Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
832
Countries
11
Sites
114
Moderate to Severe Active Ulcerative Colitis
To demonstrate equivalent efficacy of AVT16, a proposed biosimilar to Entyvio.
Key facts
- Sponsor
- Alvotech Swiss AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 29 Aug 2025 → 25 Nov 2025
- Decision date (initial)
- 2024-08-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Alvotech SWISS AG
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Efficacy, Pharmacokinetic, Therapy
To demonstrate equivalent efficacy of AVT16, a proposed biosimilar to Entyvio.
Secondary objectives 1
- To further compare the efficacy of AVT16 with Entyvio. To compare the safety of AVT16 with Entyvio. To compare the immunogenicity of AVT16 with Entyvio. To compare the PK of AVT16 with Entyvio
Conditions and MedDRA coding
Moderate to Severe Active Ulcerative Colitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10075634 | Acute haemorrhagic ulcerative colitis | 100000004856 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening period 4 weeks
|
Not Applicable | Double | [{"id":99371,"code":2,"name":"Investigator"},{"id":99372,"code":1,"name":"Subject"},{"id":99373,"code":3,"name":"Monitor"}] | |
| 2 | Active period Randomization to receive either AVT16 or Entyvio IV in a 1:1 ratio
|
Randomised Controlled | Double | [{"id":99375,"code":2,"name":"Investigator"},{"id":99376,"code":1,"name":"Subject"},{"id":99377,"code":3,"name":"Monitor"}] | Test (AVT16): Subjects will receive AVT16 300 mg IV once at Week 0, 2, 6,14, 22, 30, 38 and 46 Reference (Entyvio): Subjects will receive Entyvio 300 mg IV once at Week 0, 2, 6,14, 22, 30, 38 and 46 |
| 3 | End-of-study (EoS) visit Randomization to receive either AVT16 or Entyvio IV in a 1:1 ratio
|
Randomised Controlled | Double | [{"id":99380,"code":1,"name":"Subject"},{"id":99381,"code":3,"name":"Monitor"},{"id":99379,"code":2,"name":"Investigator"}] | Test (AVT16): Subjects will receive AVT16 300 mg IV once at Week 0, 2, 6,14, 22, 30, 38 and 46 Reference (Entyvio): Subjects will receive Entyvio 300 mg IV once at Week 0, 2, 6,14, 22, 30, 38 and 46 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Male or female subjects aged 18 to 80 years inclusive at the time of signing the informed consent form (ICF) who are voluntarily able to give informed consent. 2. Female subjects are eligible to participate if they are not pregnant, not breastfeeding, and at least ONE of the following conditions applies: a. Is not a woman of childbearing potential (WOCBP), defined as: i. Surgically sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, as confirmed by review of the subject’s medical records, medical examination, or medical history interview), or ii. Postmenopausal (defined as no menses for 12 months without an alternative medical cause). A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with more than 1 FSH measurement is required. Female subjects on HRT and whose menopausal status is in doubt will be required to use 1 of the nonestrogen hormonal highly effective contraception methods from screening (signing the ICF) until at least 18 weeks after the last investigational product (IP) administration if they want to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment. b. Is a WOCBP who agrees to use a highly effective method of contraception consistently and correctly from screening (signing the ICF) until at least 18 weeks after the last IP administration and agrees not to donate or cryopreserve ova during the course of the study and for at least 18 weeks after the last IP administration. 3. Nonsterilized male subjects with female partners of childbearing potential are eligible to participate if they agree to 1 of the following from screening (signing the ICF) until at least 18 weeks after the last IP administration: a. Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent. b. Agree to use a male condom with spermicide and have their partner use a contraceptive method with a failure rate of less than 1% per year when having penile vaginal intercourse with a WOCBP who is not currently pregnant. c. Male subjects with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom with spermicide during each episode of penile penetration. d. In addition, male subjects must refrain from donating sperm from screening (signing the ICF) until at least 18 weeks after the last IP administration. 4. Diagnosis of UC 5. Moderately to severely active UC 6. Evidence of UC 7. Subjects with extensive colitis or pancolitis of >8 years duration or left-sided colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (may be performed during screening). 8. Subjects with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or another known risk factor must be up to date on colorectal cancer surveillance (may be performed during screening). 9. Demonstrated, over the previous 5-year period, an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below: 10. May be receiving a therapeutic dose of the following drugs: a. Oral 5-aminosalicylic acid (5-ASA) compounds provided b. Oral corticosteroid therapy c. Probiotics (eg, Culturelle, Saccharomyces boulardii) d. Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea. e. Azathioprine or 6-mercaptopurine provided For the complete list please refer to protocol.
Exclusion criteria 1
- 1. Evidence of abdominal abscess or toxic megacolon or fulminant stage of disease during the screening period. 2. Extensive colonic resection, subtotal, or total colectomy. 3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine. 4. Prior treatmentfor UC. 5. Have received any of the following for the treatment: a. Other than those permitted in the study if last dose was given prior to the baseline endoscopy. 6. Use of topical (rectal) treatment prior to baseline endoscopy. 7. Evidence of or treatment prior to baseline endoscopy. 8. Currently require or are anticipated to require surgical intervention for UC during the study. 9. History or evidence of adenomatous colonic polyps that have not been removed. 10. History or evidence of any grade of colonic mucosal dysplasia. 11. Diagnosis of Crohn’s colitis or indeterminate colitis. Infectious Disease Exclusion Criteria 12. Chronic hepatitis B or C infection: Subjects with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune subjects (ie, HBsAg-negative and hepatitis B antibody–positive) may, however, be included. Note: If a subject tests negative for HBsAg, but positive for HBcAb, the subject would be considered eligible if the absence of HBV DNA is confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central laboratory. Subjects with chronic hepatitis C virus (HCV) (ie, positive HCV antibody [HCVAb] and HCV RNA). Note: Subjects who are HCVAb positive without evidence of HCV RNA may be considered eligible in the event of spontaneous viral clearance or previously treated and cured (defined as no evidence of HCV RNA at least 12 weeks before baseline). 13. Active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following: a. History of TB. b. A positive diagnostic TB test within 1 month of enrollment defined as: i. a positive QuantiFERON® test or 2 successive indeterminate QuantiFERON tests c. Chest X-ray within 3 months of enrollment in which active or latent pulmonary TB cannot be excluded Note: Subjects with an indeterminate QuantiFERON test are allowed if they have all of the following d. No evidence of active TB on chest radiograph within 3 months prior to the first dose of IP e. Documented history of 3 weeks of prophylaxis initiation prior to receiving IP in accordance with local recommendations and intends to complete its entire course during the study f. No known exposure to active TB after most recent prophylaxis g. Asymptomatic at screening and baseline Investigators should check with the medical monitor before enrolling such subjects 14. Any identified congenital or acquired immunodeficiency 15. Any live vaccinations within 30 days prior to IP administration except for an influenza vaccine 16. Clinically significant extra-intestinal infection within 30 days prior to baseline endoscopy 17. Previous exposure to vedolizumab 18. Female subjects who are lactating or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 0 prior to IP administration 19. Any unstable or uncontrolledmedical disorder that, in the opinion of the investigator, would confound the study results or compromise subject safety 20. Have had any surgical procedure requiring general anesthesia within 30 days prior to baseline endoscopy or are planning to undergo major surgery during the study period 21. Any history of malignancy, except for the following: (a) adequately treated nonmetastatic basal cell skin cancer; (b) any other type of nonmelanoma skin cancer that has been adequately treated and has not recurred for at least 5 years prior to baseline endoscopy; and (c) adequately treated in situ cervical cancer that has not recurred for at least 5 years prior to baseline endoscopy 22. History of any major neurological disorders For the complete list please refer to protocol.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Clinical Response at Week 6, defined as a reduction in the complete Mayo Clinic score in the rectal bleeding subscore of or an absolute rectal bleeding subscore at Week 6.
Secondary endpoints 3
- Clinical Response at Weeks 14, 22, 30, 38, and Week 46 Clinical Response at Week 52 Clinical Remission at Week 6 and Week 52. Clinical Remission at Week 52. Mucosal healing at Week 6 and Week 52 Glucocorticoid-free remissionc at Week 52 Albumin levels at Baseline, Week 6, and Week 52. CRP levels at Baseline, Week 6, and Week 52.
- Incidence, nature, and severity of AEs, graded according to the current version of the CTCAE; clinical laboratory assessments (hematology, clinical biochemistry, coagulation, inflammatory markers such as the erythrocyte sedimentation rate, urinalysis, and urine microscopy), vital signs, ECG, physical examination findings, targeted physical examination findings, infusion drug-related reactions, and injection site reactions.
- Titer and frequency of ADA. Frequency of NAb. Serum trough concentration of AVT16 and Entyvio at Weeks 0, 2, 6, 14, 22, 30, 38, 46, and 52.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10946391 · Product
- Active substance
- Vedolizumab
- Substance synonyms
- MLN0002, PB016
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 46 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- L04AA33 — -
- MA holder
- ALVOTECH SWISS AG
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
Entyvio 300 mg powder for concentrate for solution for infusion
PRD2468450 · Product
- Active substance
- Vedolizumab
- Substance synonyms
- MLN0002, PB016
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 46 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AG05 — -
- Marketing authorisation
- EU/1/14/923/001
- MA holder
- TAKEDA PHARMA A/S
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaged and relabelled for blinding purposes
Auxiliary 1
Isotonische Kochsalzlösung Fresenius
PRD2128227 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 250 ml millilitre(s)
- Max total dose
- 250 ml millilitre(s)
- Max treatment duration
- 46 Week(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- 6096595.00.00
- MA holder
- FRESENIUS KABI DEUTSCHLAND GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- RELABELLED for central distribution
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Alvotech Swiss AG
- Sponsor organisation
- Alvotech Swiss AG
- Address
- Thurgauerstrasse 54
- City
- Zurich
- Postcode
- 8050
- Country
- Switzerland
Scientific contact point
- Organisation
- Alvotech Swiss AG
- Contact name
- Fausto Berti
Public contact point
- Organisation
- Alvotech Swiss AG
- Contact name
- Luboslava Pihornova
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Fisher Clinical Services GmbH ORG-100012942
|
Allschwil, Switzerland | Code 14 |
| Norwich Clinical Services Private Limited ORG-100037434
|
Bengaluru, India | Code 8 |
| Nuvisan GmbH ORG-100011873
|
Neu-Ulm, Germany | Other, Laboratory analysis |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| BioAgilytix Europe GmbH ORG-100016335
|
Hamburg, Germany | Other, Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management, E-data capture |
| PPD Development LP ORG-100011560
|
Wilmington, United States | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 2, Interactive response technologies (IRT), Laboratory analysis, Code 5, Data management, E-data capture, Code 8 |
| Fisher Clinical Services GmbH ORG-100017323
|
Weil Am Rhein, Germany | Code 14 |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Interactive response technologies (IRT) |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| PPD International Holdings LLC ORG-100007655
|
Zaventem, Belgium | Laboratory analysis |
Locations
11 EU/EEA countries · 114 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 29 | 10 |
| Croatia | Ended | 19 | 7 |
| Czechia | Ended | 17 | 7 |
| Greece | Ended | 11 | 5 |
| Hungary | Ended | 22 | 10 |
| Italy | Ended | 33 | 14 |
| Latvia | Ended | 8 | 3 |
| Poland | Ended | 298 | 45 |
| Romania | Ended | 8 | 3 |
| Slovakia | Ended | 16 | 6 |
| Spain | Ended | 1 | 4 |
| Rest of world
Argentina, Ukraine, Bosnia and Herzegovina, Peru, India, Serbia, Mexico, Georgia, Sri Lanka, Colombia
|
— | 370 | — |
Investigational sites
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
Department of Gastroenterology, Ulitsa Dimitir Pehlivanov 5, 8800, Sliven
Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie Medika Ruse OOD
Department of Internal Diseases, Ulitsa Riga 35, 7013, Ruse
Medical Center Hera EOOD
n/a, Ulitsa Klisura 20, 1510, Sofiya
Umbal - Prof. D-R Stoyan Kirkovich AD
Department of Gastroenterology, Ulitsa General Stoletov 2, 6003, Stara Zagora
MBAL Sveta Karidad EAD
Department of Gastroenterology, Bulevard Aleksandir Stamboliyski 31, 4004, Plovdiv
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Clinic of Gastroenterology, Zdrave Street 29, 8001, Burgas
Diagnostic Consultation Center XX-Sofia EOOD
n/a, Ulitsa Gen. Stefan Toshev 15, 1618, Sofia
Medical Center Medconsult Pleven OOD
n/a, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven
First Private MHAT - Vratsa EOOD
Department of Internal Diseases, 95 Gen. Leonov Street, 3000, Vratsa
Medical center Asclepion humane medicine researches EOOD
n/a, Ulitsa Damyan Gruev 8a, 1303, Sofia
General Hospital Dr. Josip Bencevic
Gastroenterology, endocrinology and diabetology department, Ulica Dr. Andrije Stampara 42, 35000, Slavonski Brod
Specijalna Bolnica Medico
Gastroenterology and Hepatology, Agaticeva 8, 51000, Rijeka
Poliklinika Bates
Gastroenterology, Svetice 15, Zagreb, Grad Zagreb
KBC Split
Department of gastroenterology, Spinciceva 1, 21000, Split
Poliklinika Borzan d.o.o.
Gastroenterology, Dubrovacka 12, 31000, Osijek
Poliklinika Solmed d.o.o.
Clinical Research, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
Opca Bolnica Dr. Andelko Visic Bjelovar
Gastroenterology and pulmology, Antuna Mihanovica 8, 43000, Bjelovar
CCR Ostrava s.r.o.
N/A, 28. Rijna 3348/65, Moravska Ostrava, Moravska Ostrava A Privoz
Nemocnice Milosrdnych Sester Sv. Karla Boromejskeho V Praze
Gastroenterologie, Vlasska 336/36, Mala Strana, Prague
Vojenska Nemocnice Brno
Interní oddělení, Zabrdovicka 3, Zabrdovice, Brno-Zidenice
PreventaMed s.r.o.
Interní ambulance, Domovina 774/2, 779 00, Olomouc
Endohope klinika s.r.o.
N/A, Obloukova 1335/3, Vrsovice, Prague
Endohope Havirov s.r.o.
N/A, Dlouha Trida 1134/83, Podlesí, Havirov
Nemocnice Slany
Interní oddělení, Politickych Veznu 576, 274 01, Slany
University General Hospital Of Heraklion
Gastroenterology Department, Stavrakia And Voutes, 715 00, Heraklion
Evangelismos S.A.
Gastroenterology Department, Ipsiladou 45-47, 106 76, Athens
Alexandra Hospital
Hepato-Gastroenterology Department, Vassilissas Sofias Avenue 80, 115 28, Athens
Geniko Nosokomeio Peiraia Tzaneio
Gastroenterology Department, Zanni And Afentouli Street, 185 36, Piraeus
University General Hospital Of Thessaloniki Ahepa
Gastroenterelogy Department, 1st St Kiriakidis Str, 546 36, Thessaloniki
Semmelweis University
Belgyógyászati és Onkológiai Klinika, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Gasztoenterológiai osztály, Dozsa Gyorgy Ut 77, 2800, Tatabanya
MIND Klinika Kft.
N/A, Lovohaz Utca 39, Kerulet, Budapest II
University Of Pecs
Belgyógyászati és Gasztroenterológiai Osztály, Szepessy Ter 7, 7700, Mohacs
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Infektológiai Intézet, Albert Florian Ut 5-7, 1097, Budapest IX
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
I.Sz. Belgyógyászati Osztály, Seregelyesi Ut 3, 8000, Szekesfehervar
Javorszky Oedoen Korhaz
Gasztroenterológiai osztály, Argenti Dome Ter 1-3, 2600, Vac
Semmelweis University
I.Sz. Belgyógyászati Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Bekes Varmegyei Koezponti Korhaz
4. Belgyógyászat-Gasztroenterológia, Gyulai Ut 18, 5600, Bekescsaba
Obudai Egeszseguegyi Centrum Kft.
N/A, Lajos Utca 74-76, 1036, Budapest III
Congregazione Delle Suore Infermiere Dell'Addolorata
UOC Gastroenterologia, Via Dante Alighieri 11, 22100, Como
Humanitas Mirasole S.p.A.
Unità Malattie Infiammatorie Croniche Intestinali (IBD Center), Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliera Ordine Mauriziano Di Torino
SC Gastroenterologia, Via Ferdinando Magellano 1, 10128, Turin
Azienda Sanitaria Locale Roma 2
UOC Transmurale di Gastroenterologia ed Endoscopia Digestiva, Via Dei Monti Tiburtini 385, 00157, Rome
Casa Sollievo Della Sofferenza
UOC di Gastroenterologia ed Endoscopia Digestiva, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
National Institute Of Gastroenterology Saverio De Bellis Research Hospital
U.O.S. Malattie Infiammatorie Croniche Intestinali, Via Turi 27, 70013, Castellana Grotte
Ospedale San Raffaele S.r.l.
Gastroenterologia ed Endoscopia digestiva, Via Olgettina 60, 20132, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC di Medicina Interna e Gastroenterologia, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Unità Operativa di Gastroenterologia ed Epatologia, Via Del Vespro 129, 90127, Palermo
Policlinico San Donato S.p.A.
Unità di Gastroenterologia ed Endoscopia Digestiva, Piazza Edmondo Malan 2, 20097, San Donato Milanese
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
S.C. Medicina ad indirizzo Epatologico e Gastroenterologico, Via Antonio Di Rudini' 8, 20142, Milan
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
UOSD Malattie Infettive Croniche Intestinali, Via Trabucco 180, 90146, Palermo
Azienda Ospedaliero Universitaria Di Modena
Struttura Complessa di Gastroenterologia ed Endoscopia Digestiva, Largo Del Pozzo 71, 41124, Modena
Fondazione IRCCS Policlinico San Matteo
UOC Gastroenterologia Dipartimento di Medicina Interna e Terapia Medica, Viale Camillo Golgi 19, 27100, Pavia
Pauls Stradins Clinical University Hospital
N/A, Pilsonu Iela 13, 1002, Riga
Digestive Diseases Centre Gastro SIA
N/A, Gailezera Iela 1, 1079, Riga
Liepajas Regionala Slimnica SIA
N/A, Slimnicas Iela 25, 3414, Liepaja
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
n/a, Zamiejska 17, 03-580, Warsaw
EMC Instytut Medyczny S.A.
Prywatna Lecznica Certus Szpital Nr 1, Prywatna Lecznica Certus Ambulatorium, Ul. Grunwaldzka 156, 60-309, Poznan
Mz Badania Slowik Zymla Sp. j.
n/a, Ul. Ks. Alojzego Kozielka 8, 44-190, Knurow
Nzoz For Med Sp. z o.o.
n/a, Ul. Lwowska 93, 34-100, Wadowice
Centrum Medyczne Lukamed JOANNA ŁUKA
n/a, Ul. Mickiewicza 39, 89-600, Chojnice
Pratia S.A.
Centrum Medyczne Pratia Poznań, Ul. Poznanska 14, 60-185, Skorzewo
Centrum Medyczne Medyk Sp. z o.o. S.K.
n/a, Al. Tadeusza Rejtana 53, 35-326, Rzeszow
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
n/a, U2 U3 U4 U5, Ul. Tadeusza Szafrana 5d, Cracow
Twoja Przychodnia - Opolskie Centrum Medyczne
n/a, ul. Kurpiowska 6/2, 45-819, Opole
Amicare Sp. z o.o. S.K.
AmiCare Centrum Medyczne, Ul. Zgierska 249, 91-495, Lodz
Endoskopia Sp. z o.o.
n/a, Ul. Boleslawa Chrobrego 6/8, 81-756, Sopot
Globe Badania Kliniczne Sp. z o.o.
n/a, Ul. Janusza Kusocinskiego 3a, 57-300, Klodzko
Gastromed Sp. z o.o.
n/a, Ul. Grudziadzka 11/13-14, 87-100, Torun
Eb Group Sp. z o.o.
Centrum Zdrowia MDM, Ul. Inflancka 4a, 00-189, Warsaw
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
n/a, Ul. Macieja Jakubowskiego 2, 30-688, Cracow
Medrise Sp. z o.o.
n/a, Ul. Onyksowa 10, 20-582, Lublin
Vistamed & Vertigo Sp. z o.o.
n/a, Ul Raclawicka 105 1b, 53-149, Wroclaw
Korczowski Bartosz, Gabinet Lekarski
n/a, ul. Litewska 4A/7, 35-302, Rzeszow
EMC Instytut Medyczny S.A.
n/a, Ul. Pilczycka 144/148, 54-144, Wroclaw
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
n/a, Ul. Ul. Jana Dlugosza 4, 51-162, Wroclaw
Centrum Medyczne Uno-Med Sp. z o.o.
n/a, Ul. Gumniska 11, 33-100, Tarnow
Wsd Medi Clinical Sp. z o.o.
n/a, Aleja Jana Rodowicza "Anody" 22/U4, 02-786, Warszawa
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
n/a, Ul. Dr Stefana Kopcinskiego 22, 90-153, Lodz
Sonomed Sp. z o.o.
n/a, Ul. Ks. Bp. Wladyslawa Bandurskiego 98/u12, 71-685, Szczecin
Medical Network Sp. z o.o.
n/a, Ul. Plowiecka 103, 04-501, Warsaw
Wojewodzki Szpital Specjalistyczny W Olsztynie
n/a, Ul. Zolnierska 18, 10-561, Olsztyn
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
n/a, Ul. Polskiej Organizacji Wojskowej 12 C, 97-300, Piotrkow Trybunalski
H-T.Centrum Medyczne Sp. z o.o. sp.k.
H-T. Centrum Medyczne - Endoterapia, Aleja Bielska 103a, 43-100, Tychy
Santa Sp. z o.o. sp.k.
n/a, Ul. Zagorska 20/26, 25-355, Kielce
Dc-Med Sp. z o.o. S.K.
n/a, Ul. Dworcowa 5, 58-100, Swidnica
Bodyclinic Sp. z o.o. sp.k.
n/a, Ul. Ulica Jozefa Sierakowskiego 4/u3, 03-712, Warsaw
Pro Life Medica Sp. z o.o.
ETG Zamość, Ul. Spadek 41, 22-400, Zamosc
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
n/a, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
Centrum Opieki Zdrowotnej Orkan-Med Stec - Michalska Sp. j.
n/a, Ul. Wladyslawa Orkana 3, 95-054, Ksawerow
4 Wojskowy Szpital Kliniczny Z Polikliniką Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
n/a, Ul. Rudolfa Weigla 5, 50-981, Wroclaw
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.
n/a, Os. Lecha 15a, 61-293, Poznan
Vitamed Galaj I Cichomski Sp. j.
n/a, Ul. Tadeusza Kosciuszki 35, 85-079, Bydgoszcz
Topolowa Medicenter Ryszawa & Wspolnicy Sp. j.
n/a, Ul. Topolowa 33/7, 31-506, Cracow
Centrum Medyczne Clw-Med Aneta Cichomska I Joanna Luka-Wendrowska Sp. j.
n/a, Ul. Mieszka I 5, 86-300, Grudziadz
Manermed Sp. z o.o.
Centrum Medyczne Medis, Ul. Garbary 5/l4, 85-229, Bydgoszcz
M2M Med. Sp. z o.o. Sp. j.
n/a, Ul. Lwowska 34, 41-500, Chorzow
Gyncentrum Sp. z o.o.
NZOZ Holsamed – Oddział Libero, Ul. Tadeusza Kosciuszki 229, 40-600, Katowice
Dc-Med. Michał Kowalski S.k.
n/a, ul. Kilińskiego 6, 26-610, Radom
Klinika Reuma Park Sp. z o.o. S.K.
CENTRUM MEDYCZNE REUMA PARK, Aleja Wilanowska 333, 02-665, Warsaw
Centrum Leczenia Migre
N/A, Łubinowa 12/7, 52-210, Wrocław
Cabinet Particular Policlinic Algomed S.R.L.
Gastroenterology Department, Strada Blaga Lucian Nr 4, 300002, Timisoara
Spitalul Clinic Judetean Mures
Gastroenterology Department, Piata Bernady Gyorgy Nr 6, 540072, Targu Mures
Gastromed S.R.L.
Gastroenterology Department, Strada Bucuresti 21, 900161, Constanta
Fakultna Nemocnica Trnava
N/A, Andreja Zarnova 11, 917 02, Trnava
Gastro LM s.r.o.
N/A, Jurkovicova 7081/18, 080 01, Presov
Endomed s.r.o.
Gastroenterologická ambulancia, Americka Trieda 17, Poliklinika Tahanovce, Kosice
Penta Hospitals SK a.s.
Gastroenterologická ambulancia, Srobarova 1, 979 01, Rimavska Sobota
F D Roosevelt University General Hospital Of Banska Bystrica
N/A, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica
Cliniq s.r.o.
Gastroenterologická ambulancia, Bezrucova 5, Stare Mesto, Bratislava
Centro Medico Teknon-Grupo Quironsalud
Digestivo, Calle Vilana 12, 08022, Barcelona
Hospital Universitario Reina Sofia
Digestivo, Avenida Menendez Pidal S/n, 14004, Cordoba
Complexo Hospitalario Universitario De Santiago
Digestivo, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario De Navarra
Digestivo, Irunlarrea Kalea 3, 31008, Pamplona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Bulgaria | 2024-10-09 | 2024-11-05 | 2025-04-25 | ||
| Croatia | 2024-10-15 | 2024-12-05 | 2025-04-25 | ||
| Latvia | 2024-09-20 | 2024-10-22 | 2025-04-25 | ||
| Poland | 2024-09-17 | 2024-09-23 | 2025-04-25 | ||
| Romania | 2024-10-10 | 2025-01-16 | 2025-04-25 | ||
| Slovakia | 2024-09-26 | 2024-10-16 | 2025-04-25 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 18 · Art. 38 CTR
Temporary halt TH-90424
- Halt date
- 2025-04-25
- Member states concerned
- Latvia
- Publication date
- 2025-07-14
- Reason
- Sponsor decision, Study management related
- Explanation
- Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025. This decision is not related to any safety concern arising from the use of the product. This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial. In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)). As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened. All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Note: This is administrative resubmission of temporary halt due to ticket number: INC0133360. - Follow-up measures
- Participants will continue with treatment according to the protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-90423
- Halt date
- 2025-04-25
- Member states concerned
- Croatia
- Publication date
- 2025-07-14
- Reason
- Sponsor decision, Study management related
- Explanation
- Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025. This decision is not related to any safety concern arising from the use of the product. This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial. In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)). As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened. All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Note: This is administrative resubmission of temporary halt due to ticket number: INC0133360. - Follow-up measures
- Participants will continue with treatment according to the protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-90422
- Halt date
- 2025-04-25
- Member states concerned
- Romania
- Publication date
- 2025-07-14
- Reason
- Sponsor decision, Study management related
- Explanation
- Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025. This decision is not related to any safety concern arising from the use of the product. This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial. In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)). As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened. All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Note: This is administrative resubmission of temporary halt due to ticket number: INC0133360. - Follow-up measures
- Participants will continue with treatment according to the protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-90421
- Halt date
- 2025-04-25
- Member states concerned
- Poland
- Publication date
- 2025-07-14
- Reason
- Sponsor decision, Study management related
- Explanation
- Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025. This decision is not related to any safety concern arising from the use of the product. This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial. In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)). As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened. All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Note: This is administrative resubmission of temporary halt due to ticket number: INC0133360. - Follow-up measures
- Participants will continue with treatment according to the protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-90420
- Halt date
- 2025-04-25
- Member states concerned
- Bulgaria
- Publication date
- 2025-07-14
- Reason
- Sponsor decision, Study management related
- Explanation
- Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025. This decision is not related to any safety concern arising from the use of the product. This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial. In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)). As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened. All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Note: This is administrative resubmission of temporary halt due to ticket number: INC0133360. - Follow-up measures
- Participants will continue with treatment according to the protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-80891
- Halt date
- 2025-04-25
- Member states concerned
- Bulgaria
- Publication date
- 2025-04-30
- Reason
- Sponsor decision, Study management related
- Explanation
- "Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025.
This decision is not related to any safety concern arising from the use of the product.
This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial.
In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)).
As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened.
All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Number of patients is provided below, based on the status as of 28th of April 2025. - Follow-up measures
- Patients will continue with the treatment according to the protocol
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-90419
- Halt date
- 2025-04-25
- Member states concerned
- Slovakia
- Publication date
- 2025-07-14
- Reason
- Study management related, Sponsor decision
- Explanation
- Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025. This decision is not related to any safety concern arising from the use of the product. This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial. In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)). As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened. All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Note: This is administrative resubmission of temporary halt due to ticket number: INC0133360. - Follow-up measures
- Participants will continue with treatment according to the protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-95868
- Halt date
- 2025-08-25
- Member states concerned
- Slovakia
- Publication date
- 2025-08-29
- Reason
- Sponsor decision, Study management related
- Explanation
- "Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025.
This decision is not related to any safety concern arising from the use of the product.
This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial.
In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)).
As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened.
All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Number of patients is provided below, based on the status as of 28th of April 2025."
Note as of 29-Aug-2025:
As per recommendation of EMA IT helpdesk in ticket number INC0139041:
Please be note per system design, currently it is not possible to submit/update a Serious Breach when a trial is temporarily halted. As a WA you can temporarily restart the trial in order to submit the Serious Breach, then submit the halt of trial again.
Based on EMA IT recommendation, Alvotech updated SB notification, and put the trial on hold again. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-95869
- Halt date
- 2025-08-25
- Member states concerned
- Bulgaria
- Publication date
- 2025-08-29
- Reason
- Sponsor decision, Study management related
- Explanation
- "Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025.
This decision is not related to any safety concern arising from the use of the product.
This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial.
In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)).
As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened.
All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Number of patients is provided below, based on the status as of 28th of April 2025."
Note as of 29-Aug-2025:
As per recommendation of EMA IT helpdesk in ticket number INC0139041:
Please be note per system design, currently it is not possible to submit/update a Serious Breach when a trial is temporarily halted. As a WA you can temporarily restart the trial in order to submit the Serious Breach, then submit the halt of trial again.
Based on EMA IT recommendation, Alvotech updated SB notification, and put the trial on hold again. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-80889
- Halt date
- 2025-04-25
- Member states concerned
- Croatia
- Publication date
- 2025-04-30
- Reason
- Sponsor decision, Study management related
- Explanation
- "Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025.
This decision is not related to any safety concern arising from the use of the product.
This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial.
In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)).
As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened.
All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Number of patients is provided below, based on the status as of 28th of April 2025. - Follow-up measures
- Patients will continue with the treatment according to the protocol
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-95871
- Halt date
- 2025-08-25
- Member states concerned
- Romania
- Publication date
- 2025-08-29
- Reason
- Sponsor decision, Study management related
- Explanation
- "Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025.
This decision is not related to any safety concern arising from the use of the product.
This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial.
In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)).
As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened.
All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Number of patients is provided below, based on the status as of 28th of April 2025."
Note as of 29-Aug-2025:
As per recommendation of EMA IT helpdesk in ticket number INC0139041:
Please be note per system design, currently it is not possible to submit/update a Serious Breach when a trial is temporarily halted. As a WA you can temporarily restart the trial in order to submit the Serious Breach, then submit the halt of trial again.
Based on EMA IT recommendation, Alvotech updated SB notification, and put the trial on hold again. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-95870
- Halt date
- 2025-08-25
- Member states concerned
- Poland
- Publication date
- 2025-08-29
- Reason
- Sponsor decision, Study management related
- Explanation
- "Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025.
This decision is not related to any safety concern arising from the use of the product.
This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial.
In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)).
As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened.
All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Number of patients is provided below, based on the status as of 28th of April 2025."
Note as of 29-Aug-2025:
As per recommendation of EMA IT helpdesk in ticket number INC0139041:
Please be note per system design, currently it is not possible to submit/update a Serious Breach when a trial is temporarily halted. As a WA you can temporarily restart the trial in order to submit the Serious Breach, then submit the halt of trial again.
Based on EMA IT recommendation, Alvotech updated SB notification, and put the trial on hold again. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-95873
- Halt date
- 2025-08-25
- Member states concerned
- Latvia
- Publication date
- 2025-08-29
- Reason
- Sponsor decision, Study management related
- Explanation
- "Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025.
This decision is not related to any safety concern arising from the use of the product.
This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial.
In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)).
As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened.
All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Number of patients is provided below, based on the status as of 28th of April 2025."
Note as of 29-Aug-2025:
As per recommendation of EMA IT helpdesk in ticket number INC0139041:
Please be note per system design, currently it is not possible to submit/update a Serious Breach when a trial is temporarily halted. As a WA you can temporarily restart the trial in order to submit the Serious Breach, then submit the halt of trial again.
Based on EMA IT recommendation, Alvotech updated SB notification, and put the trial on hold again. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-95872
- Halt date
- 2025-08-25
- Member states concerned
- Croatia
- Publication date
- 2025-08-29
- Reason
- Sponsor decision, Study management related
- Explanation
- "Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025.
This decision is not related to any safety concern arising from the use of the product.
This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial.
In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)).
As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened.
All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Number of patients is provided below, based on the status as of 28th of April 2025."
Note as of 29-Aug-2025:
As per recommendation of EMA IT helpdesk in ticket number INC0139041:
Please be note per system design, currently it is not possible to submit/update a Serious Breach when a trial is temporarily halted. As a WA you can temporarily restart the trial in order to submit the Serious Breach, then submit the halt of trial again.
Based on EMA IT recommendation, Alvotech updated SB notification, and put the trial on hold again. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-80893
- Halt date
- 2025-04-25
- Member states concerned
- Latvia
- Publication date
- 2025-04-30
- Reason
- Sponsor decision, Study management related
- Explanation
- "Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025.
This decision is not related to any safety concern arising from the use of the product.
This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial.
In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)).
As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened.
All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Number of patients is provided below, based on the status as of 28th of April 2025. - Follow-up measures
- Patients will continue with the treatment according to the protocol
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-80895
- Halt date
- 2025-04-25
- Member states concerned
- Poland
- Publication date
- 2025-04-30
- Reason
- Sponsor decision, Study management related
- Explanation
- "Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025.
This decision is not related to any safety concern arising from the use of the product.
This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial.
In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)).
As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened.
All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Number of patients is provided below, based on the status as of 28th of April 2025. - Follow-up measures
- Patients will continue with the treatment according to the protocol
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-80897
- Halt date
- 2025-04-25
- Member states concerned
- Romania
- Publication date
- 2025-04-30
- Reason
- Sponsor decision, Study management related
- Explanation
- "Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025.
This decision is not related to any safety concern arising from the use of the product.
This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial.
In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)).
As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened.
All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Number of patients is provided below, based on the status as of 28th of April 2025. - Follow-up measures
- Patients will continue with the treatment according to the protocol
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-80899
- Halt date
- 2025-04-25
- Member states concerned
- Slovakia
- Publication date
- 2025-04-30
- Reason
- Sponsor decision, Study management related
- Explanation
- "Participant recruitment for the clinical trial AVT16- GL-C01 is being temporarily halted with an effective date on Friday 25-Apr-2025.
This decision is not related to any safety concern arising from the use of the product.
This decision has been made as Alvotech is awaiting feedback from the health authorities about the scientific/regulatory necessity of the study. This feedback may have significant implications on the role of the trial.
In alignment with ethical and scientific principles, Alvotech has decided to temporarily halt recruitment in the study to avoid exposing participants to a clinical trial setting, as continuing a trial without scientific necessity would violate the foundational ethical principle of non-maleficence (do no harm). This action is taken in accordance with the International Council for Harmonization Guideline for Good Clinical Practice (ICH GCP E6(R2)).
As of Friday, 25-Apr-2025, end of the day (recruitment halt), the IRT system was closed for new screenings. Participants, who have already been screened before the recruitment halt will be allowed to continue the screening process and, if eligible, will be randomized. Participants declared ineligible are not allowed to be re-screened.
All ongoing study procedures for currently enrolled participants should continue as per the protocol. All participants screened in the study as of 25-Apr-2025 and successfully enrolled will be permitted to continue treatment according to the current protocol.
Number of patients is provided below, based on the status as of 28th of April 2025. - Follow-up measures
- Patients will continue with the treatment according to the protocol
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 56 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Recruitment arrangements (for publication) | K1_AVT16-GL-C01_Informed-Consent and Patient-Recruitment-Procedure_SVK_Public | n/a |
| Recruitment arrangements (for publication) | K1_AVT16-GL-C01_Recruitment and Informed Consent procedure_HU_Public | n/a |
| Recruitment arrangements (for publication) | K1_AVT16-GL-C01_Recruitment-and Informed-Consent-Procedure_CZE_Public | N/A |
| Recruitment arrangements (for publication) | K1_AVT16-GL-C01_Recruitment-and-Informed-consent-procedure_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_AVT16-GL-C01_Recruitment-Arrangements_ES_Public | 1 |
| Recruitment arrangements (for publication) | K1_AVT16-GL-C01_Recruitment-Arrangements_GRC_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_AVT16-GL-C01_Recruitment-Arrangements_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_AVT16-GL-C01 _GP-Letter_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_AVT16-GL-C01_ Poster_GRC_Greek_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_AVT16-GL-C01_Flyer_GRC_Greek_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_AVT16-GL-C01_Flyer_HU_Hungarian_Public | 2 |
| Recruitment arrangements (for publication) | K2_AVT16-GL-C01_Flyer_PL_Polish_Public | 2 |
| Recruitment arrangements (for publication) | K2_AVT16-GL-C01_Poster_HU_Hungarian_Public | 2 |
| Recruitment arrangements (for publication) | K2_AVT16-GL-C01_Poster_PL_Polish_Public | 2 |
| Recruitment arrangements (for publication) | K2_AVT16-GL-C01_Ulcerative-Colitis-Flyer_CZE_Czech_Public | 2 |
| Recruitment arrangements (for publication) | K2_AVT16-GL-C01_Ulcerative-Colitis-Flyer_IT_Italian | 3.0 |
| Recruitment arrangements (for publication) | K2_AVT16-GL-C01_Ulcerative-Colitis-Poster_CZE_Czech_Public | 2 |
| Recruitment arrangements (for publication) | K2_AVT16-GL-C01_Ulcerative-Colitis-Poster_IT_Italian | 3.0 |
| Recruitment arrangements (for publication) | K2_AVT16-GL-C01_UlcerativeColitis_Flyer_SVK_Slovak_Public | 2 |
| Recruitment arrangements (for publication) | K2_AVT16-GL-C01_UlcerativeColitis_Poster_SVK_Slovak_Public | 2 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_GDPR-ICF_SVK_Slovak_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_GDPR-Notice_CZE_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Main ICF_HU_Hungarian_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Main-ICF_CZE_Czech_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Main-ICF_ES_Spanish_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Main-ICF_GRC_English_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Main-ICF_GRC_Greek_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Main-ICF_IT_Italian_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Main-ICF_PL_Polish_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Main-ICF_SVK_Slovak_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Preg-Part-Preg-Particip-Newborn-ICF_ES_Spanish_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Pregnancy Follow Up ICF_HU_Hungarian_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Pregnancy Follow Up-ICF_SVK_Slovak_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Pregnancy FU ICF_IT_Italian_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Pregnancy-Follow-up-ICF_PL_Polish_Public | 2.1 adm. 1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Pregnant Partner ICF_HU_Hungarian_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Pregnant Partner-ICF_SVK_Slovak_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Pregnant-Partner-ICF_CZE_Czech_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Pregnant-Partner-ICF_IT_Italian_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Pregnant-Partner-ICF_PL_Polish_Public | 2.1 adm. 1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Pregnant-Partner-Participant-Infant-ICF_GRC_English_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Pregnant-Partner-Participant-Infant-ICF_GRC_Greek_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Privacy ICF_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Scout-ICF_CZE_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Scout-ICF_SVK_Slovak_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_AVT16-GL-C01_Study Information_Public | n/a |
| Subject information and informed consent form (for publication) | L2_AVT16-GL-C01_Patient card_HU_Hungarian_Public | 1.2.0 |
| Subject information and informed consent form (for publication) | L2_AVT16-GL-C01_Patient Card_SVK_Slovak_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L3_AVT16-GL-C01_eCOA PIN Activation_QRC_SVK_Slovak_final_Public | 1.1 |
| Subject information and informed consent form (for publication) | L3_AVT16-GL-C01_eCOA PIN ActivationPD_QRC_SVK_Slovak_final_Public | 1.0 |
| Subject information and informed consent form (for publication) | L3_AVT16-GL-C01_MSS_Diary_Final Screens_SVK_Slovak_Public | n/a |
| Subject information and informed consent form (for publication) | L3_AVT16-GL-C01_MSS_History_Final Screens_SVK_Slovak_Public | n/a |
| Subject information and informed consent form (for publication) | L3_AVT16-GL-C01_Patient Cloud Notification_Final Report_SVK_Slovak_Public | n/a |
| Subject information and informed consent form (for publication) | L3_AVT16-GL-C01_SC_PFD_Email Comm_SVK_Slovak_Public | 1.0 |
| Subject information and informed consent form (for publication) | L3_AVT16-GL-C01_SC_PFD_Study Brochure_SVK_Slovak_Public | 1.0 |
| Subject information and informed consent form (for publication) | L3_AVT16-GL-C01_Stool Sample Instructions_SVK_Slovak_Public | 1.0 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-29 | Latvia | Acceptable 2024-08-19
|
2024-08-20 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-04 | Acceptable 2024-08-19
|
2024-09-04 | |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-10-23 | Acceptable 2024-08-19
|
2025-01-21 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-10-28 | Acceptable 2024-08-19
|
2025-02-04 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2024-10-28 | 2025-02-05 | ||
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2024-10-29 | Acceptable 2024-08-19
|
2025-02-04 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-30 | Acceptable | 2024-12-10 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2024-10-30 | 2025-01-09 |