Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
1,200
Countries
21
Sites
168
Crohn’s Disease
1.Study 1: US/FDA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per Crohn’s Disease Activity Index score at Week 52 2.Study 1: EU/EMA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportio…
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 24 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2023-508636-61-00
- WHO UTN
- U1111-1298-6080
- ClinicalTrials.gov
- NCT06430801
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Dose response, Pharmacodynamic, Therapy, Safety, Pharmacokinetic
1.Study 1: US/FDA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per Crohn’s Disease Activity Index score at Week 52
2.Study 1: EU/EMA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per stool frequency and abdominal pain score at Week 52
3.Study 1: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving endoscopic response at Week 52
4.Study 1: US/FDA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per Crohn’s Disease Activity Index score at Week 12
5.Study 1: EU/EMA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per stool frequency and abdominal pain score at Week 12
6.Study 1: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving endoscopic response at Week 12
Secondary objectives 20
- Study 1: To evaluate the safety and tolerability of tulisokibart
- Study 1: US/FDA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per stool frequency and abdominal pain score at Week 12
- Study 1: EU/EMA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per Crohn’s Disease Activity Index score at Week 12
- Study 1: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants with a decrease of at least 100 points in Crohn’s Disease Activity Index from baseline at Week 12
- Study 1: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the mean change from baseline in the Functional Assessment of Chronic Illness Therapy – Fatigue at Week 12
- Study 1: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants with endoscopic remission at Week 12
- Study 1: To evaluate the efficacy of tulisokibart compared with placebo in the Dx+ subpopulation as assessed by the proportion of participants with Crohn’s Disease Activity Index clinical remission at Week 12
- Study 1: To evaluate the efficacy of tulisokibart compared with placebo in the Dx+ subpopulation as assessed by the proportion of participants endoscopic response at Week 12
- Study 1: US/FDA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per stool frequency and abdominal pain score at Week 52
- Study 1: EU/EMA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per Crohn’s Disease Activity Index score at Week 52
- Study 1: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants with a decrease of at least 100 points in Crohn’s Disease Activity Index from baseline at Week 52
- Study 1: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants with endoscopic remission at Week 52
- Study 1: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants with sustained clinical remission per Crohn’s Disease Activity Index at both Week 12 and Week 52
- Study 1: US/FDA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants with clinical remission CDAI score at Week 52, in participants taking corticosteroids for CD at baseline
- Study 1: EU/EMA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants with clinical remission per corticosteroid free stool frequency/abdominal pain score at Week 52, in participants taking corticosteroids for CD at baseline
- Study 1: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants clinical remission per stool frequency and abdominal pain score and endoscopic remission at Week 52
- Study 1: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants with Crohn’s Disease Activity Index clinical remission and endoscopic remission at Week 52
- Study 1: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the mean change from baseline in the Functional Assessment of Chronic Illness Therapy – Fatigue at Week 52
- Study 1: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the mean change from baseline in the Inflammatory Bowel Disease Questionnaire at Week 52
- Study 1: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants with ulcer-free endoscopy at Week 52
Conditions and MedDRA coding
Crohn’s Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10013099 | Disease Crohns | 10017947 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Has had a diagnosis of Crohn’s Disease (CD) at least 3 months before study.
- Has moderately to severely active CD.
- Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
- Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority.
Exclusion criteria 14
- Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
- Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
- Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
- Has current stoma or need for colostomy or ileostomy.
- Is missing >2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
- Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn’s disease.
- Has surgical bowel resection within 3 months of study.
- Has prior or current gastrointestinal dysplasia.
- Has chronic infection requiring ongoing antimicrobial treatment.
- Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years.
- Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Has active tuberculosis.
- Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
- Prior exposure to tulisokibart (MK-7240, PRA023) or another anti- tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 6
- Study 1 [US/FDA]: Percentage of Participants Achieving Clinical Remission per Crohn’s Disease Activity Index (CDAI) Score at Week 52
- Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
- Study 1: Percentage of Participants Achieving Endoscopic Response at Week 52
- Study 1 [US/FDA only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
- Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
- Study 1: Percentage of Participants Achieving Endoscopic Response at Week 12
Secondary endpoints 21
- Study 1: Number of Participants Who Experienced an Adverse Event (AE)
- Study 1: Number of Participants who Discontinue Study Intervention due to an AE
- Study 1 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
- Study 1 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
- Study 1: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 12
- Study 1: Mean Change from Baseline in Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue) Score at Week 12
- Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 12
- Study 1: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI at Week 12
- Study 1: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Endoscopic Response at Week 12
- Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
- Study 1: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 52
- Study 1: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 52
- Study 1: Percentage of Participants Achieving Endoscopic Remission at Week 52
- Study 1: Percentage of Participants Achieving Sustained Clinical Remission per CDAI at Week 12 and Week 52
- Study 1 [US/FDA]:: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per CDAI Score at Week 52
- Study 1 [EU/EMA]: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 52
- Study 1: Percentage of Participants Achieving Clinical Remission per Stool Frequency, Abdominal Pain Score, and Endoscopic Remission at Week 52
- Study 1: Percentage of Participants Achieving Clinical Remission per CDAI and Endoscopic Remission at Week 52
- Study 1: Mean Change from Baseline in FACIT-Fatigue Score at Week 52
- Study 1: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 52
- Study 1: Percentage of Participants with Ulcer-Free Endoscopy at Week 52
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10740873 · Product
- Active substance
- Tulisokibart
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED INJECTOR
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 208 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10740872 · Product
- Active substance
- Tulisokibart
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Placebo to Subcutaneous or intravenous MK-7240 (Tulisokibart)
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Paulette Chandler
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Paulette Chandler
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Syneos Health Clinique Inc. ORG-100028348
|
Quebec, Canada | Laboratory analysis |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Interactive response technologies (IRT) |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Alimentiv B.V. ORG-100030611
|
Amsterdam, Netherlands | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| PPD International Holdings LLC ORG-100007655
|
Zaventem, Belgium | Laboratory analysis |
Locations
21 EU/EEA countries · 168 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 10 | 3 |
| Belgium | Ongoing, recruitment ended | 10 | 3 |
| Croatia | Ongoing, recruitment ended | 22 | 5 |
| Czechia | Ongoing, recruitment ended | 15 | 6 |
| Denmark | Ongoing, recruitment ended | 6 | 2 |
| Finland | Ongoing, recruitment ended | 6 | 3 |
| France | Ongoing, recruitment ended | 60 | 21 |
| Germany | Ongoing, recruitment ended | 70 | 17 |
| Greece | Ongoing, recruitment ended | 12 | 5 |
| Hungary | Ongoing, recruitment ended | 27 | 9 |
| Ireland | Ended | 8 | 1 |
| Italy | Ongoing, recruitment ended | 38 | 15 |
| Latvia | Ongoing, recruitment ended | 6 | 2 |
| Lithuania | Ongoing, recruitment ended | 6 | 2 |
| Netherlands | Ongoing, recruitment ended | 22 | 9 |
| Poland | Ongoing, recruitment ended | 150 | 33 |
| Portugal | Ongoing, recruitment ended | 28 | 7 |
| Romania | Ongoing, recruitment ended | 16 | 6 |
| Slovakia | Ongoing, recruitment ended | 20 | 5 |
| Spain | Ongoing, recruitment ended | 29 | 11 |
| Sweden | Ongoing, recruitment ended | 6 | 3 |
| Rest of world
Saudi Arabia, Switzerland, Singapore, Colombia, United Kingdom, Serbia, Peru, United States, Georgia, Chile, Hong Kong, Israel, China, Taiwan, Mexico, Australia, Malaysia, Ukraine, Japan, Turkey, Brazil, Korea, Republic of, South Africa, Canada, New Zealand
|
— | 633 | — |
Investigational sites
Medizinische Universitaet Innsbruck
Medizinishe Universität Innsbruck Universitätsklinik für Innere Medizin I, Anichstrasse 35, 6020, Innsbruck
Medical University Of Vienna
Medinzinische Universität Wien Abteilung für Gastroenterologie und Hepatologie, 7I, Waehringer Guertel 18-20, Alsergrund, Vienna
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Uniklinikum Salzburg Universitätsklinik für Innere Medizin I Landeskrankenhaus, Muellner Hauptstrasse 48, 5020, Salzburg
Universitair Ziekenhuis Gent
IBD-centrum, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Maag-darm-leverziekten, Herestraat 49, 3000, Leuven
Algemeen Ziekenhuis Delta
Maag-darm-leverziekten, Deltalaan 1, 8800, Roeselare
University Hospital Centre Zagreb
Zavod za gastroenterologiju i hepatologiju, Ulica Mije Kispatica 12, 10000, Zagreb
Poliklinika Solmed d.o.o.
NA, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
Poliklinika Bates
NA, Svetice 15, Zagreb, Grad Zagreb
Poliklinika Borzan d.o.o.
NA, Dubrovacka 12, 31000, Osijek
Klinicka bolnica Merkur
NA, Ulica Ivana Zajca 19, 10000, Zagreb
Iscare a.s.
Klinické centrum ISCARE a.s., Ceskomoravska 2510/19, Liben, Prague
Vojenska Nemocnice Brno
Interní oddělení, Zabrdovicka 3, Zabrdovice, Brno-Zidenice
Pratia Brno s.r.o.
Gastroenterologicka ambulance, Hybesova 258/20, Stare Brno, Brno-Stred
Hepato-Gastroenterologie HK s.r.o.
Hepato-Gastroenterologie, Trida Edvarda Benese 1549/34, 500 12, Hradec Kralove
Institute For Clinical And Experimental Medicine
Klinika hepatogastroentrologie, Videnska 1958/9, Krc, Prague
Nemocnice Slany
Gastroenterologická a hepatologická ambulance, Politickych Veznu 576, 274 01, Slany
Odense University Hospital
Gastroenterologisk afdeling, Kloevervaenget 47, 5000, Odense C
Region Hovedstaden
Afdeling for mave-, tarm- og leversygdomme, Borgmester Ib Juuls Vej 1, 2730, Herlev
North Karelia Central Hospital
Gastroenterology, Tikkamaentie 16, 80210, Joensuu
Tampere University Hospital
Gastroenterology Outpatient Clinic, Elamanaukio 2, 33520, Tampere
Turku University Hospital
Gastroenterology Outpatient Clinic, Kiinamyllynkatu 4-8, 20520, Turku
Centre Hospitalier Universitaire De Nantes
Hépato-Gastro-Entérologie, 1 Place Alexis Ricordeau, 44000, Nantes
Assistance Publique Hopitaux De Paris
Hépato-Gastro-Entérologie, 78 Rue Du General Leclerc, 94270, Le Kremlin-Bicetre
Centre Hospitalier Universitaire De Nice
Hépato-Gastro-Entérologie, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Lille
Hépato-Gastro-Entérologie, Rue Michel Polonovski, 59037, Lille Cedex
Centre Hospitalier Universitaire Amiens Picardie
Hépato-Gastro-Entérologie, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier Universitaire Reims
Hépato-Gastro-Entérologie, 45 Rue Cognacq Jay, 51092, Reims Cedex
Centre Hospitalier Valence
Hépato-Gastro-Entérologie, 179 Boulevard Marechal Juin, 26000, Valence
Hospices Civils De Lyon
Hépato-Gastro-Entérologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Dijon
Hépato-Gastro-Entérologie, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire De Nimes
Hépato-Gastro-Entérologie, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Assistance Publique Hopitaux De Paris
Hépato-Gastro-Entérologie, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
CHU Besancon
Hépato-Gastro-Entérologie, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Medico Chirurgical Ambroise Pare Hartmann
Hépato-Gastro-Entérologie, 25 Boulevard Victor Hugo, 92200, Neuilly-Sur-Seine
Centre Hospitalier Universitaire De Toulouse
Hépato-Gastro-Entérologie, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire De Montpellier
Hépato-Gastro-Entérologie, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Regional De Marseille
Hépato-Gastro-Entérologie, 265 Chemin Des Bourrely, 13015, Marseille
Centre Hospitalier Universitaire De Bordeaux
Hépato-Gastro-Entérologie, Avenue De Magellan, 33600, Pessac
Assistance Publique Hopitaux De Paris
Hépato-Gastro-Entérologie, 100 Boulevard Du General Leclerc, 92110, Clichy
CHRU De Nancy
Hépato-Gastro-Entérologie, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Clinique Des Cedres.
Hépato-Gastro-Entérologie, 21 Rue Albert Londres, 38130, Echirolles
Assistance Publique Hopitaux De Paris
Hépato-Gastro-Entérologie, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil
Staedtisches Klinikum Lueneburg gGmbH
Klinik für Allgemeine Innere Medizin, Gastroenterologie und Pneumologie, Boegelstrasse 1, Mittelfeld, Lueneburg
Universitaetsklinikum Ulm AöR
Klinik für Innere Medizin I CED-Studienambulan, Albert-Einstein-Allee 23, Eselsberg, Ulm
Magen-Darm-Zentrum-Remscheid
Magen-Darm-Zentrum Remscheid, Rosenhügelerstr. 2, 42859, Remscheid
Medizinisches Versorgungszentrum Portal 10
Zentrum für Leber-, Magen- und Darmerkrankungen, Albersloher Weg 10, 48155, Muenster
Medizinisches Versorgungszentrum fuer spezialaerztliche Versorgung Professor Dr. Friedrichs GmbH
Medizinisches Versorgungszentrum fuer spezialaerztliche Versorgung Professor Dr. Friedrichs GmbH, Zu Den Rehwiesen 9, Wanheimerort, Duisburg
Universitaetsklinikum Schleswig-Holstein AöR
Campus Kiel Klinik für Innere Medizin, Arnold-Heller-Strasse 3, Brunswik, Kiel
Siloah St Trudpert Klinikum
Klinik für Innere Medizin I, Wilferdinger Strasse 67, Nordstadt, Pforzheim
Medizinische Hochschule Hannover
Klinik für Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Brandenburg an der Havel GmbH
Klinik für Innere Medizin II, Hochstrasse 29, Altstadt, Brandenburg An Der Havel
Rostock University Medical Center
Zentrum für Innere Medizin, Ernst-Heydemann-Strasse 6, Hansaviertel, Rostock
Gastroenterologische Gemeinschaftspraxis Minden
-, Hausberger Str. 2b, 32423, Minden
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik für Hepatologie und Gastroenterologie, Augustenburger Platz 1, Wedding, Berlin
Universitaetsklinikum Leipzig AöR
Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Klinikum rechts der Isar der TU Muenchen AöR
Klinik und Poliklinik für Innere Medizin II, Ismaninger Strasse 22, Au-Haidhausen, Munich
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik II, Marchioninistrasse 15, Hadern, Munich
St. Marien Und St. Annastiftskrankenhaus
Klinik für Innere Medizin, Salzburger Strasse 15, Gartenstadt, Ludwigshafen Am Rhein
Evangelisches Krankenhaus Kalk gGmbH
Klinik für Gastroenterologie, Pulmologie, allg. Innere Medizin, Buchforststrasse 2, Kalk, Cologne
Evangelismos S.A.
Gastroenterology Department, Ipsiladou 45-47, 106 76, Athens
Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis I
Department of Gastroenterology, Dimitrios Mantouvalos Str. 3, 184 54, Νikaia
University General Hospital Of Heraklion
Department of Gastroenterology, Stavrakia And Voutes, 715 00, Heraklion
Thoracic General Hospital Of Athens I Sotiria
GI Unit, 3rd Academic Department of Internal Medicine, Messogion Avenue 152, 115 27, Athens
Hippokration Hospital
2nd Propedeutic Department of Internal Medicine, Konstadinoupoleos 49, 546 42, Thessaloniki
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
Belgyógyászati-Infektológiai Centrum, Gasztroenterológiai Részleg, Knezich Karoly Utca 1, 3300, Eger
Gyoengyosi Bugat Pal Koerhaz
Gasztroenterológiai Egység, Dozsa Gyorgy Utca 20-22, 3200, Gyongyos
Pannonia Maganorvosi Centrum Kft.
N/A, Pannonia Utca 35-37, 1136, Budapest XIII
VeszLife Kft.
N/A, Szofia Utca 2/1, 8200, Veszprem
Clinexpert Kft.
N/A, Kaszasdulo Utca 5, 1033, Budapest III
Central Hospital Of Northern Pest Military Hospital
Gasztroenterológia, Podmaniczky Utca 109, 1062, Budapest VI
Bekes Varmegyei Koezponti Korhaz
4.Belgyógyászat- 2.Gasztroenterológia, Gyulai Ut 18, 5600, Bekescsaba
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Gasztroenterológia, Dozsa Gyorgy Ut 77, 2800, Tatabanya
Semmelweis University
Sebészeti, Transzplantációs és Gasztroenterológiai Klinika, Ulloi Ut 78, 1082, Budapest
Azienda Ospedaliero-Universitaria Di Cagliari
S.C. Gastroenterologia, Strada Statale 554 N. 1, 09042, Monserrato
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
U.O.S.D. Malattie Infiammatorie Croniche dell'Intestino (M.I.C.I.), Via Trabucco 180, 90146, Palermo
IRCCS Ospedale Sacro Cuore Don Calabria
Malattie Croniche Intestinali – IBD Unit, Via Don Angelo Sempreboni 5, 37024, Negrar
Azienda Ospedaliero Universitaria Careggi
S.O.D. Gastroenterologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Struttura Semplice Dipartimentale per le Malattie Infiammatorie Croniche Intestinali, Via Pietro Albertoni 15, 40138, Bologna
University Hospital Consorziale Policlinico
U.O. Gastroenterologia, Piazza Giulio Cesare 11, 70124, Bari
Azienda Ospedaliera Policlinico Universitario Tor Vergata
U.O.C. Gastroenterologia, Viale Oxford 81, 00133, Rome
Azienda Ospedaliera Dei Colli
U.O.C. Gastroenterologia ed Endoscopia Digestiva, Via Leonardo Bianchi, 80131, Naples
Humanitas Mirasole S.p.A.
Unità Operativa Malattie Infiammatorie Croniche Intestinali, Via Alessandro Manzoni 56, 20089, Rozzano
Ospedale San Raffaele S.r.l.
Unità Operativa di Gastroenterologia ed Endoscopia Digestiva, Via Olgettina 60, 20132, Milan
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Unità di Gastroenterologia ed Endoscopia, Via Francesco Sforza 28, 20122, Milan
Azienda Ospedaliera Universitaria Gaetano Martino Messina
UOC Gastroenterologia e Malattie Intestinali Croniche Dip. di Medicina Clinica e Sperimental, Via Consolare Valeria N 1, 98124, Messina
Azienda Ospedaliera Ordine Mauriziano Di Torino
S.C. Gastroenterologia, Via Ferdinando Magellano 1, 10128, Turin
Azienda Unita Sanitaria Locale Toscana Nord Ovest
Endoscopia Digestiva, Via Roma 147, 56025, Pontedera
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC CEMAD - UOS Malattie Infiammatorie Croniche Intestinali, Largo Francesco Vito 1, 00168, Rome
Pauls Stradins Clinical University Hospital
Gastroenterology department, Pilsonu Iela 13, 1002, Riga
M & M centrs SIA
Doctor practice, Gaujas Iela 11, 6, Adazi
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Gastroenterology department, Eiveniu G. 2, Kauno M. Sav., Kaunas
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Department of Clinical trails and Pharmacology, Santariskiu G 2, Vilniaus M. Sav., Vilnius
Novamed Robert Koteras
Twoja Przychodnia Opolskie Centrum Medyczne, ul. Kurpiowska 6/2, 45-819, Opole
Sint Franciscus Vlietland Groep Stichting
Department of Gastroenterology & hepatology, Kleiweg 500, 3045 PM, Rotterdam
Stichting Radboud universitair medisch centrum
Department of Gastroenterology & hepatology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Universitair Medisch Centrum Groningen
Department of Gastroenterology & hepatology, Hanzeplein 1, 9713 GZ, Groningen
Bernhoven B.V.
Department of Gastroenterology & hepatology, Nistelrodeseweg 10, 5406 PT, Uden
Universitair Medisch Centrum Utrecht
Department of Gastroenterology & hepatology, Heidelberglaan 100, 3584 CX, Utrecht
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department of Gastroenterology & hepatology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Amsterdam UMC
Department of Gastroenterology & hepatology, De Boelelaan 1117, 1081 HV, Amsterdam
Stichting Elisabeth-Tweesteden Ziekenhuis
Department of Gastroenterology & hepatology, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Topolowa Medicenter Ryszawa & Wspolnicy Sp. j.
NA, Ul. Topolowa 33/7, 31-506, Cracow
EMC Instytut Medyczny S.A.
Prywatna Lecznica Certus – Szpital i Ambulatorium, Ul. Grunwaldzka 156, 60-309, Poznan
Etg Zamosc Sp. z o.o.
ETG Zamość Poradnie Specjalistyczne, Ul. Gesia 3, 22-400, Zamosc
Planetmed Sp. z o.o.
N/A, Ul. Lubinowa 12/8, 52-210, Wroclaw
Allmedica Badania Kliniczne Sp. z o.o. sp.k.
N/A, Ul. Kowaniec 2a, 34-400, Nowy Targ
Promed P.Lach R.Glowacki Sp. j.
Centrum Medyczne PROMED, Ul. Olszanska 5g, 31-513, Cracow
H-T.Centrum Medyczne Sp. z o.o. sp.k.
Endoterapia, Aleja Bielska 103a, 43-100, Tychy
Amicare Sp. z o.o. S.K.
N/A, Ul. Jozefa Ignacego Kraszewskiego 8/17, 58-500, Jelenia Gora
Medicome Sp. z o.o.
Oświęcimskie Centrum Badań Klinicznych, Plac Tadeusza Kosciuszki 12, 32-600, Oswiecim
EMC Instytut Medyczny S.A.
EuroMediCare Przychodnia Specjalistyczna we Wrocławiu, Ul. Pilczycka 144/148, 54-144, Wroclaw
M2M Med. Sp. z o.o. Sp. j.
N/A, Ul. Lwowska 34, 41-500, Chorzow
Medrise Sp. z o.o.
N, Ul. Onyksowa 10, 20-582, Lublin
Vistamed & Vertigo Sp. z o.o.
NA, Ul Raclawicka 105 1b, 53-149, Wroclaw
Futuremeds Sp. z o.o.
NA, Ul. Mikolaja Kopernika 32, 31-501, Cracow
Gastromed Sp. z o.o.
N/A, Ul. Grudziadzka 11/13-14, 87-100, Torun
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.
NA, Ul. Barska 13, 87-800, Wloclawek
Etg Warszawa Sp. z o.o.
N/A, Ul. Wynalazek 4, 02-677, Warsaw
Eb Group Sp. z o.o.
Centrum Zdrowia MDM, Ul. Inflancka 4a, 00-189, Warsaw
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Twoja Przychodnia SCM, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
Pratia S.A.
Pratia Poznań, Ul. Gryfinska 1, 60-192, Poznan
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Gastroenterologii Onkologicznej, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Endoskopia Sp. z o.o.
N/A, Ul. Boleslawa Chrobrego 6/8, 81-756, Sopot
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Centrum Medyczne Plejady, Ul. Tadeusza Szafrana 5d / U2-U5, 30-363, Cracow
Sonomed Sp. z o.o.
N/A, Ul. Ks. Bp. Wladyslawa Bandurskiego 98/u12, 71-685, Szczecin
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Kliniczny Oddział Gastroenterologii, Hepatologii i Chorób Wewnętrznych, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
Ip Clinic Sp. z o.o.
N/A, Ul. Gen. Lucjana Zeligowskiego 3/5, 90-752, Lodz
Melita Medical Sp. z o.o.
NA, Ul. Strzegomska 2-4, 53-611, Wroclaw
Centrum Medyczne Med-Gastr Sp. z o.o.
N/A, Ul. Mokra 4, 91-034, Lodz
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
NZOZ Centrum Medyczne KERmed, Ul. Krolowej Jadwigi 16, 85-231, Bydgoszcz
Vivamed Sp. z o.o.
NA, Ul. Zamiejska 17, 03-580, Warsaw
Amicare Sp. z o.o. S.K.
N/A, Ul. Zgierska 249, 91-495, Lodz
Medical Network Sp. z o.o.
WIP Warsaw IBD Point Profesor Kierkuś, Ul. Plowiecka 103, 04-501, Warsaw
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
Twoja Przychodnia PCM, Ul. Marcelinska 92, 60-324, Poznan
Lusiadas S.A.
Serviço de Gastroenterologia, Rua Abilio Mendes 12, 1500-458, Lisbon
Unidade Local de Saude do Algarve E.P.E.
Serviço de Gastroenterologia, Sitio Do Poco Seco, 8500-338, Portimao
Hospital Da Luz S.A.
Serviço de Gastroenterologia, Avenida Lusiada 100, 1500-650, Lisbon
Unidade Local De Saude Do Alto Ave E.P.E.
Serviço de Gastroenterologia, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes
Unidade Local De Saude Do Alto Minho E.P.E.
Serviço de Gastroenterologia, Estrada De Santa Luzia, 4904-858, Viana Do Castelo
Unidade Local De Saude Da Regiao De Leiria E.P.E.
Serviço de Gastroenterologia, Rua Das Olhalvas, 2410-197, Leiria
Unidade Local De Saude De Viseu Dao-Lafoes E.P.E.
Serviço de Gastroenterologia, Avenida Rei Dom Duarte, 3504-509, Viseu
Memorial Healthcare International S.R.L.
Gastroenterologie, Soseaua Ionescu-Sisesti Gheorghe Nr 8a, 013823, Bucharest
Institutul Clinic Fundeni
Gastroenterologie, Soseaua Fundeni 258, 022328, Bucharest
Gastro Med S.R.L.
Gastroenterologie, Strada Moldovei Nr. 3, 400380, Cluj-Napoca
Asociatia Oncohelp
Gastroenterologie, Strada Porumbescu Ciprian 59, 300239, Timisoara
Monza-Ares S.R.L.
Gastroenterology, Strada Bulandra Tony Actor Nr. 27 Sectorul 2, 021967, Bucharest
Spitalul Clinic Judetean Mures
Gastroenterologie, Strada Marinescu Gheorghe Nr. 1, 540103, Targu Mures
Gastro I. s.r.o.
Gastroenterologická ambulancia, Jana Holleho 5898/14, 080 01, Presov
KM Management spol. s r.o.
Gastroenterologické a hepatologické centrum, Hodzova 408/46, 949 01, Nitra
F D Roosevelt University General Hospital Of Banska Bystrica
Gastroenterologická ambulancia, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica
Gastro LM s.r.o.
Gastroenterológia, Jurkovicova 7081/18, 080 01, Presov
Cliniq s.r.o.
Gastroenterologické centrum, Bezrucova 5, Stare Mesto, Bratislava
Area Sanitaria De Ferrol
Departamente de Gastroenterologia, Avenida Residencia S/n, 15405, Ferrol
Hospital Universitario Miguel Servet
Servicio de Gastroenterología, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Clinic De Barcelona
Servicio de Gastroenterología, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Puerta De Hierro De Majadahonda
Aparato Digestivo, Calle De San Martin De Porres 4, 28035, Madrid
Complexo Hospitalario Universitario De Pontevedra
Aparato Digestivo, Calle Mourente S/n, 36164, Pontevedra
Hospital Universitario Y Politecnico La Fe
Aparato Digestivo, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Germans Trias I Pujol
Aparato Digestivo, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario Nuestra Senora De Candelaria
Aparato Digestivo, Carretera De Rosario 145, Resto, Santa Cruz De Tenerife
Hospital Universitario La Paz
Aparato Digestivo, Paseo De La Castellana 261, 28046, Madrid
Hospital Clinico Universitario De Valencia
Aparato Digestivo, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario De Torrejon
Aparato Digestivo, Calle De Mateo Inurria 1, 28850, Torrejon De Ardoz
Karolinska University Hospital
Tema Inflammation & Åldrande, IBD Mag-Tarm, Forskning, Eugeniavagen 3, 171 64, Solna
Danderyds Sjukhus AB
Gastrosektionen VO Medicinsk Specialistvård, Morbygardsvagen 88, 182 88, Danderyd
Region Oestergoetland
Mag-tarmmedicinska kliniken, Universitetssjukhuset I Linkoping, 581 85, Linkoping
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 |
|---|---|---|---|---|---|
| Austria | 2025-01-03 | 2025-07-08 | 2026-05-19 | ||
| Belgium | 2025-02-07 | 2025-02-07 | 2026-05-19 | ||
| Croatia | 2025-02-25 | 2025-03-07 | 2026-05-19 | ||
| Czechia | 2025-05-16 | 2025-05-20 | 2026-05-19 | ||
| Denmark | 2025-04-09 | 2025-08-14 | 2026-05-19 | ||
| Finland | 2024-12-27 | 2025-01-13 | 2026-05-19 | ||
| France | 2024-11-12 | 2024-11-12 | 2026-05-19 | ||
| Germany | 2024-11-05 | 2024-11-06 | 2026-05-19 | ||
| Greece | 2024-12-23 | 2025-01-02 | 2026-05-19 | ||
| Hungary | 2024-11-25 | 2025-01-02 | 2026-05-19 | ||
| Ireland | 2025-08-05 | 2026-03-20 | |||
| Italy | 2024-11-20 | 2024-12-09 | 2026-05-19 | ||
| Latvia | 2025-06-17 | 2025-07-28 | 2026-05-19 | ||
| Lithuania | 2025-05-08 | 2025-07-10 | 2026-05-19 | ||
| Netherlands | 2024-10-24 | 2024-11-27 | 2026-05-19 | ||
| Poland | 2025-01-27 | 2025-02-05 | 2026-05-19 | ||
| Portugal | 2024-10-31 | 2025-02-04 | 2026-05-19 | ||
| Romania | 2024-11-11 | 2024-11-25 | 2026-05-19 | ||
| Slovakia | 2025-02-07 | 2025-04-03 | 2026-05-19 | ||
| Spain | 2025-02-24 | 2025-03-14 | 2025-09-15 | ||
| Sweden | 2024-11-07 | 2025-07-15 | 2026-05-19 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Serious breaches 1 · Art. 52 CTR
Serious breach SB-96667
- Sponsor became aware
- 2025-08-29
- Date of breach
- 2025-08-25
- Submission date
- 2025-09-05
- Member states concerned
- Austria, Croatia, Finland, France, Germany, Greece, Hungary, Italy, Portugal, Romania, Spain, Sweden, Netherlands, Slovakia, Belgium, Czechia, Denmark, Ireland, Latvia, Lithuania, Poland
- Categories
- Protocol
- Areas impacted
- Subject rights
- Benefit-risk balance changed
- No
- Description
- Product: MK7240
Protocol Number: MK7240-008
EU CTR number: 2023-508636-61-00
Per protocol, only the first infusion dose requires the full amount of Investigational Medical Product (IMP) contained in the vial. All subsequent doses should use half contents of the vial. One participant on MK7240-008, received an overdose on Visits 3 and 5 with full vials due to incorrect dose preparation by the site as wrong prep (prep) protocol was selected in CATO pharmacy drug dispensing system.
On 25Aug 2025, Research Nurse discovered Visit 3 overdosing when collecting information for data entry. Site Pharmacy did an immediate recheck of other dosing, and a second overdose was discovered. PI and participant were informed the evening of 25Aug2025, and no AEs or any symptoms were reported. Sponsor was notified on 26Aug2025.
Root cause (provided by site with sponsor review): Study participant ‘overdosed’ due to incorrect dose preparation by the site as wrong prep protocol was selected in pharmacy drug dispensing system (CATO) due to unclear description/naming convention of prep protocol and application process at site. At this site, there is a Clinical Trials Unit (CTU) and separate Preparation Unit. The preparation pharmacist is responsible for defining preparation protocols in the system, but process errors contributed to preparation mistakes. The CTU pharmacy transfers vials with a non protocol-specific site application form to the Prep Unit, which uses this form to retrieve protocol-specific preparation instructions by visit from CATO. Sponsor CRA called CTU between Visits 2 and 3 to remind of dose change, and the IRT confirmation includes change warning, the CTU didn’t highlight on application form, and it is not confirmed if IRT printout was included in application per instruction. Additionally, prep protocols were ambiguously named and visit names on the application form did not match those in the CATO system. As a result, at Visits 3 and 5, the Preparation Unit selected incorrect protocols, causing misdosing. Although a secondary quality check exists, unclear naming led to these errors being overlooked.
This is determined to be a potential serious breach based on impact to participant rights by receiving double the protocol-defined dose at Visit 3 and Visit 5. Root cause is determined to be at site level. This case was considered along with Serious Breach report SB-67370 for a participant in Croatia on MK7240-001 at Site ORG-100048409/LOC-100080172, for which the sponsor program team has further controlled through substantial programmatic preventive actions that are under continued evaluation including targeted CAPA effectiveness check. At the time of prior report on 21/Jan/2025, 10 participants on MK7240-001 (US, China, Argentina, and Croatia) and 1 participant on MK7240-008 (US) had been exposed to an overdose during induction. Executable actions at study level were implemented and may be referred to in SB-67370. No other overdoses have been reported at this time, until this site event. As of 25Aug2025, study team reported that 2,182 infusions have been given in study MK7240-008 with a 0.13% infusion overdose (3 events) rate.
For SB-67370 submission, SB 2nd reason of “Other” was marked denoting: “Potential Participant Safety (no SAEs, or significant safety events reported at this time; potential impact to participant safety is being evaluated as part of the overall investigation).” In review of the doses administered for this participant (Visit 2 and 5 correct dose, Visit 3 and 5 full vial), Cmax remains within the range of previously observed values of exposure from Phase 1 study (NCT04676178 - max 1000 mg IV single dose) where no clinically significant adverse events were observed. At this time, it is unknown if participants are on active IMP or placebo. Based on the cases of overdoses reported, there is no observation of any clinically significant outcomes/events - Sponsor actions
- Actions Taken/Planned for site as of 29Aug2025:
Corrective Actions:
• Principal Investigator and Participant notified the evening of 25Aug2025.
• 25Aug25 AE check participant: no AEs after 1st and last overdose. Participant was informed to alert site if AEs occur and will continue to be monitored as active participant.
• 25Aug25 Recheck preparation protocols at site for all subjects in MK7240-001 (1 participant) and MK7240-008 (2 participants) -no other overdoses found
• 26Aug25 Notification to Sponsor
• Unscheduled visit - Participant came in for safety labs and metabolic panel: no reported AE related to the overdoses or clinically meaningful changes in lab results following each overdose
• 27Aug25 Pharmacist checked all processes and the system to obtain root cause, meeting with sponsor 28Aug25 to discuss findings
• 27Aug25 Important Protocol Deviation logged
• 27Aug25 Action Item at site opened by CRA to document corrective and preventive action measures with site.
Preventative Actions:
• Site has indicated implementation of additional QC step, above the 2nd level QC already in place, when preparation protocol has been selected in system (extra check by pharmacist; CRA to verify planned update at next site visit.
• Preparation protocol name has been adjusted to prevent incorrect selection and remove ambiguity. Specific Weeks are added to instructions to differentiate loading dose at Visit 2 instructions, versus Visit 3,4, 5 Induction instructions. These were released 28Aug2025.
• Application Form (CTU provides preparation unit) instructions updated to clearly add phase and type of visit, and reinforcement of procedure to include IRT instructions with application form.
• Reinforcement of timely data entry by CRA to enable identification of overdoses earlier at sponsor level, to prevent additional cases.
• Site to review all dosing information for Merck Studies in CATO system and confirm correct
• CSSM to instruct CRM/CRA to contact site when next participant is screened to review dosing instructions
CRA will review preventive actions with site at next scheduled visit week of 08Sep2025. Country Operations to review with Headquarters team week of 15Sep2025 post site visit. Country Quality will review case to determine additional actions as indicated. In addition, programmatic directives related to prevention of overdoses will continue at site, and a supplemental notification and discussion occurred at the 27Aug2025 Global Clinical Trial Team Meeting to enforce preventive measures at sites.
| Organisation | City | Country | Type |
|---|---|---|---|
| Stichting Radboud universitair medisch centrum | Nijmegen | Netherlands | Clinical investigator |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 302 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-508636-61_GRC_EL_SM17_for pub | 02R |
| Protocol (for publication) | D1_Protocol_2023-508636-61_SM17_for pub | 02R |
| Protocol (for publication) | D4_Subject questionnaire_ePROs_SM17_for pub | 04DEC2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_AUT_EN_SM17-RFI004_for pub | 1-6 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_BEL_EN_SM17_for pub | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DEU_EN_SM30_for pub | v3 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FIN_FI_SM17_for pub | 09APR2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_SM17_for pub | 10APR2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_GRC_EN_for pub | 14JUN2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_HRV_EN_for pub | 19JUN2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_HUN_EN_SM31_for pub | 22SEP2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ITA_EN_SM31_for pub | 13NOV2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_LTU_LT_for pub | 2-0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_LVA_EN_for pub | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_NLD_EN_SM31_for pub | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_POL_PL_SM18_for pub | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_PRT_EN_SM31_for pub | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ROU_RO_SM08-RFI002_for pub | 28JAN2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_Study 1_DNK_EN_SM17_for pub | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_Study 1_IRL_EN_SM17_for pub | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_SVK_SK_for pub | 20June2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_SWE_SV_SM17_for pub | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_CZE_CS_for pub | 08APR2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_ESP_ES_for pub | 23FEB2024R |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Advertisement_DEU_DE_SM06_for pub | 08NOV2024 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Advertisement_SWE_SV_SM17_for pub | 14APR2025 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Advocacy Card_DEU_DE_SM06_for pub | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Advocacy Card_GRC_EL_SM07_for pub | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Advocacy Card_IRL_EN_for pub | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_BEL_EN_for pub | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_BEL_FR_for pub | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_BEL_NL_for pub | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_DEU_DE_SM06_for pub | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_FIN_FI_SM31_for pub | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_FRA_FR_for pub | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_GRC_EL_SM07_for pub | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_GRC_EL_SM31_for pub | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_IRL_EN_SM27_for pub | v3 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_NLD_NL_SM31_for pub | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_POL_PL_SM18_for pub | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_PRT_PT_SM29_for pub_ | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_ROU_RO_SM23-RFI001_for pub | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Clinical Trial Brochure_DEU_DE_SM06_for pub | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Community Pharmacy Landing Page_ITA_IT_SM31_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Community Pharmacy Patient Flyer_ITA_IT_SM31_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Community Pharmacy Poster_ITA_IT_SM31_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Flow Chart Study 1_IRL_EN_SM31_for pub | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Generic Template_CZE_CS_SM17_for pub | 10 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Generic Template_SVK_SK_SM17_for pub | 10 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Indication Brochure_PRT_PT_SM29_for pub | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Leave Behind Flyer_DEU_DE_SM06_for pub | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Letter of Invitation_DEU_DE_SM06_for pub | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Material Description_CZE_CS_SM17_for pub | 10.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Material Description_SVK_SK_SM17_for pub | 10.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Banner Ad_DEU_DE_SM06_for pub | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Banner Ad_FRA_FR_SM19_for pub | v3 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Banner Ad_GRC_EL_SM22_for pub | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Banner Ad_IRL_EN_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Banner Ad_ROU_RO_SM23_for pub | v3 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_AUT_DE_SM17-RFI004_for pub | 4-0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_FRA_FR_SM19_for pub | v4 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_GRC_EL_SM22_for pub | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_HUN_HU_SM25_for pub | v4 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_IRL_EN_SM27-RFI002_for pub | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_ITA_IT_SM31_for pub | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_POL_PL_SM18_for pub | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_ROU_RO_SM23_for pub | v3 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_SWE_SV_SM28_for pub | 4-0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Flyer_AUT_DE_SM17-RFI004_for pub | 3-0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Flyer_FRA_FR_SM19_for pub | v3 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Flyer_GRC_EL_SM22_for pub | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Flyer_HUN_HU_SM25_for pub | v3 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Flyer_IRL_EN_SM27_for pub | v3 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Flyer_ITA_IT_SM21_for pub | 3 |
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| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_BEL_DE_SM31_for pub | 3.1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_BEL_FR_SM31_for pub | 3.1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_BEL_NL_SM31_for pub | 3.1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_CZE_CS_SM31_for pub | 3.1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_DEU_DE_SM31_for pub | 3.1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_ESP_ES_SM31_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_FRA_FR_SM31_for pub | 3.1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_GRC_EL_SM31_for pub | 3.1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_HRV_HR_SM31_for pub | 3.1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_HUN_HU_SM31_for pub | 3.1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_ITA_IT_SM31_for pub | 3.1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_LTU_LT_SM31_for pub | 3.1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_NLD_NL_SM31_for pub | 3.1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_POL_PL_SM31_for pub | 3.1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_PRT_PT_SM31_for pub | 3.1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_ROU_RO_SM31_for pub | 3.1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_SVK_SK_SM31_for pub | 3.1 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-508636-61_SWE_SV_SM31_for pub | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2023-508636-61_AUT_DE_SM17_for pub | AM02R |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2023-508636-61_ROU_RO_SM17_for pub | 27FEB2025R |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2023-508636-61_SVK_SK_SM17_for pub | 2R |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2023-508636-61-00_CZE_CS_SM17_for pub | 2R |
Application history
43 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-02 | Spain | Acceptable 2024-10-21
|
2024-10-21 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-29 | Acceptable 2024-10-21
|
2024-10-29 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-10-29 | Acceptable 2024-10-21
|
2024-10-29 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-11-06 | Acceptable 2024-10-21
|
2025-01-16 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2024-11-06 | 2025-02-13 | ||
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2024-11-06 | Acceptable 2024-10-21
|
2025-02-06 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2024-11-06 | Acceptable 2024-10-21
|
2025-02-12 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2024-11-06 | Acceptable 2024-10-21
|
2025-02-10 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2024-11-07 | Acceptable 2024-10-21
|
2025-02-14 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-07 | Acceptable | 2024-12-11 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-12 | Acceptable | 2025-01-23 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-11-12 | Acceptable | 2025-03-03 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-13 | Acceptable | 2024-12-18 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-11-13 | Acceptable | 2025-01-06 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-11-13 | Acceptable | 2025-01-09 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-11-13 | Acceptable | 2025-02-14 | |
| 17 | SUBSEQUENT ADDITION OF MSC | APP-17 | 2024-11-14 | Acceptable 2024-10-21
|
2025-01-21 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-11-15 | Acceptable | 2024-12-03 | |
| 19 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-12-03 | Acceptable | 2025-01-21 | |
| 20 | SUBSTANTIAL MODIFICATION | SM-11 | 2024-12-13 | Spain | Acceptable | 2025-01-21 |
| 21 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-01-27 | Acceptable | 2025-03-12 | |
| 22 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-02-12 | Acceptable | 2025-03-27 | |
| 23 | SUBSTANTIAL MODIFICATION | SM-15 | 2025-02-14 | Acceptable | 2025-03-10 | |
| 24 | SUBSTANTIAL MODIFICATION | SM-16 | 2025-02-19 | Acceptable | 2025-03-13 | |
| 25 | SUBSTANTIAL MODIFICATION | SM-17 | 2025-04-15 | Spain | Acceptable 2025-06-16
|
2025-06-16 |
| 26 | SUBSTANTIAL MODIFICATION | SM-25 | 2025-07-29 | Acceptable | 2025-09-02 | |
| 27 | SUBSTANTIAL MODIFICATION | SM-26 | 2025-07-29 | Acceptable | 2025-09-15 | |
| 28 | SUBSTANTIAL MODIFICATION | SM-21 | 2025-07-30 | Acceptable | 2025-09-09 | |
| 29 | SUBSTANTIAL MODIFICATION | SM-23 | 2025-07-30 | Acceptable | 2025-09-29 | |
| 30 | SUBSTANTIAL MODIFICATION | SM-28 | 2025-07-30 | Acceptable | 2025-08-07 | |
| 31 | SUBSTANTIAL MODIFICATION | SM-24 | 2025-08-01 | Acceptable | 2025-08-27 | |
| 32 | SUBSTANTIAL MODIFICATION | SM-19 | 2025-08-04 | Acceptable | 2025-09-01 | |
| 33 | SUBSTANTIAL MODIFICATION | SM-18 | 2025-08-05 | Acceptable | 2025-09-17 | |
| 34 | SUBSTANTIAL MODIFICATION | SM-20 | 2025-08-05 | Acceptable | 2025-09-01 | |
| 35 | SUBSTANTIAL MODIFICATION | SM-22 | 2025-08-07 | Acceptable | 2025-10-03 | |
| 36 | SUBSTANTIAL MODIFICATION | SM-27 | 2025-08-08 | Acceptable | 2025-10-15 | |
| 37 | SUBSTANTIAL MODIFICATION | SM-29 | 2025-08-12 | Acceptable | 2025-08-18 | |
| 38 | SUBSTANTIAL MODIFICATION | SM-30 | 2025-09-02 | Acceptable | 2025-10-15 | |
| 39 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-10-15 | Spain | 2025-10-15 | |
| 40 | SUBSTANTIAL MODIFICATION | SM-31 | 2025-11-27 | Spain | Acceptable 2026-02-09
|
2026-02-09 |
| 41 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-02-17 | Spain | Acceptable 2026-02-09
|
2026-02-17 |
| 42 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-02-17 | Acceptable 2026-02-09
|
2026-02-17 | |
| 43 | SUBSTANTIAL MODIFICATION | SM-41 | 2026-02-17 | Acceptable | 2026-03-18 |