Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
470
Countries
14
Sites
63
Crohns Disease
Part 1: The objective is to compare the efficacy and safety of risankizumab versus ustekinumab over 48 weeks for the treatment of adult subjects with moderate to severe Crohn's Disease (CD) who have failed anti-TNF therapy. Part 2: The objective is to evaluate the long-term safety of risankizumab up to 220 weeks in su…
Key facts
- Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 25 Nov 2020 → ongoing
- Decision date (initial)
- 2023-06-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AbbVie Inc.
External identifiers
- EU CT number
- 2022-501645-70-00
- EudraCT number
- 2020-002674-26
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
Part 1: The objective is to compare the efficacy and safety of risankizumab versus ustekinumab over 48 weeks for the treatment of adult subjects with moderate to severe Crohn's Disease (CD) who have failed anti-TNF therapy.
Part 2: The objective is to evaluate the long-term safety of risankizumab up to 220 weeks in subjects who received risankizumab during Part 1 and have completed the Week 48 visit.
Primary Treatment Extension (PTE)
The objective of the optional PTE is to provide Part 2 completers with continuous treatment of risankizumab with the aim to ensure uninterrupted care in accordance with local regulations until commercially available and/or the subject can access treatment locally for up to a maximum of approximately 3 years from the Part 2 completion visit date (Week 268). Additional objectives of the PTE are to continue to investigate and evaluate long-term safety data for risankizumab.
Conditions and MedDRA coding
Crohns Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10017947 | Gastrointestinal disorders | 14 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Part 1 Part 1 is a Phase 3b, multicenter, randomized, efficacy assessor-blinded, parallel-group study to compare the efficacy and safety of risankizumab versus ustekinumab over 48 weeks. The duration of Part 1 will be approximately 73 weeks and will include a 35-day screening period, a 48-week treatment period, and a 140-day follow-up phone call after the last dose of study drug (if not participating in Part 2).
|
Randomised Controlled | Double | [{"id":178489,"code":2,"name":"Investigator"},{"id":178490,"code":1,"name":"Subject"},{"id":178487,"code":4,"name":"Analyst"},{"id":178488,"code":3,"name":"Monitor"}] | Risankizumab 600mg IV (Induction dose) & Risankizumab 360mg SC (maintenance dose): 600 mg induction dose of risankizumab intravenous (IV) administered at Baseline, Weeks 4 and 8 followed by a risankizumab maintenance dose of 360 mg subcutaneous (SC) every 8 weeks (Q8w) at Week 12. Ustekinumab weight-based IV (Induction dose) & Ustekinumab 90mg SC (maintenance dose): ustekinumab weight-based IV induction dose (≤ 55 kg: 260mg dose; >55 kg to 85 kg: 390 mg dose; or> 85 kg: 520 mg) at Baseline, then at Week 8 a 90 mg subcutaneous (SC) maintenance dose every 8 weeks as per the ustekinumab label |
| 2 | Part 2 Part 2 is an open-label long-term extension to evaluate the long-term safety of risankizumab up to 220 weeks in subjects who received risankizumab during Part 1 and have completed the Week 48 visit. Subjects will receive an open-label maintenance risankizumab dose of 360 mg SC Q8w starting at Week 52. Part 2 will continue up to an additional 220 weeks of study participation (which includes the 4-week period between Week 48 and Week 52 [the first dosing visit in Part 2] and 216 weeks of study participation), or until the study is discontinued, whichever is earlier.
|
Not Applicable | None | Risankizumab maintenance dose of 360 mg SC Q8w: Open-label maintenance risankizumab dose of 360 mg subcutaneous (SC) every 8 weeks (Q8w) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Male or female aged ≥ 18 to ≤ 80 years of age at the Baseline visit. Confirmed diagnosis of Crohns disease (CD) for at least 3 months prior to Baseline.
- Crohn's disease activity index (CDAI) score 220 – 450 at Baseline. Confirmed diagnosis of moderate to severe Crohns Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD).
- Demonstrated intolerance or inadequate response to one or more anti- TNF therapies
- If female, subject must meet the contraception recommendations
Exclusion criteria 5
- Subject with a current diagnosis of ulcerative colitis or indeterminate colitis.
- Subjects with unstable doses of concomitant CD therapy
- Receipt of CD approved biologic agents prior to baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol)
- Subject with prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).
- Subject with complications of CD (strictures, short bowel, etc.)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Part 1: Clinical remission (non-inferiority) at Week 24: CDAI < 150
- Part 1: Endoscopic remission (superiority) at Week 48: defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤ 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer
- Part 2: Evaluation of long-term safety
Secondary endpoints 5
- Achievement of clinical remission (CDA < 150) at Week 48: superiority of risankizumab vs. ustekinumab.
- Achievement of endoscopic response at Week 48, superiority of risankizumab vs. ustekinumab
- Achievement of endoscopic response at Week 24, superiority of risankizumab vs. ustekinumab
- Achievement of steroid-free endoscopic remission Week 48, superiority of risankizumab vs. ustekinumab
- Achievement of steroid-free clinical remission at Week 48, superiority of risankizumab vs. ustekinumab.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD10391031 · Product
- Active substance
- Risankizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1800 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
PRD10369455 · Product
- Active substance
- Risankizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 360 mg milligram(s)
- Max total dose
- 11520 mg milligram(s)
- Max treatment duration
- 256 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
PRD10246143 · Product
- Active substance
- Risankizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 1800 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
PRD9602765 · Product
- Active substance
- Risankizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 360 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 256 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 2
STELARA 90 mg solution for injection in pre-filled syringe
PRD3349059 · Product
- Active substance
- Ustekinumab
- Substance synonyms
- Bmab 1200, CNTO 1275, ABP-654, CNTO-1275, BAT2206, CT-P43
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 450 mg milligram(s)
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC05 — -
- Marketing authorisation
- EU/1/08/494/004
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over label for study specific use
STELARA 130 mg concentrate for solution for infusion
PRD4498328 · Product
- Active substance
- Ustekinumab
- Substance synonyms
- Bmab 1200, CNTO 1275, ABP-654, CNTO-1275, BAT2206, CT-P43
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 520 mg milligram(s)
- Max total dose
- 520 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC05 — -
- Marketing authorisation
- EU/1/08/494/005
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over label for study specific use
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Abbvie Deutschland GmbH & Co. KG
- Sponsor organisation
- Abbvie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratories Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Labcorp Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Interactive response technologies (IRT) |
| Alimentiv Inc. ORG-100006515
|
London, Canada | Other |
| Labcorp Central Laboratory Services S.a.r.l. Meyrin ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Abbvie Biotechnology GmbH ORG-100008684
|
Ludwigshafen Am Rhein, Germany | Other, Laboratory analysis |
Locations
14 EU/EEA countries · 63 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 4 | 2 |
| Belgium | Ongoing, recruitment ended | 16 | 7 |
| Bulgaria | Ongoing, recruitment ended | 15 | 4 |
| Czechia | Ongoing, recruitment ended | 15 | 3 |
| France | Ongoing, recruitment ended | 16 | 8 |
| Germany | Ongoing, recruitment ended | 16 | 5 |
| Greece | Ongoing, recruitment ended | 16 | 5 |
| Hungary | Ongoing, recruitment ended | 15 | 4 |
| Italy | Ongoing, recruitment ended | 16 | 8 |
| Netherlands | Ended | 16 | 2 |
| Poland | Ongoing, recruitment ended | 4 | 1 |
| Romania | Ongoing, recruitment ended | 15 | 1 |
| Slovakia | Ongoing, recruitment ended | 16 | 4 |
| Spain | Ongoing, recruitment ended | 16 | 9 |
| Rest of world
United States, Korea, Republic of, Switzerland, Israel, United Kingdom, China, Japan, Argentina, Ukraine, Chile, Canada, Brazil, Turkey, Russian Federation, Australia, Mexico
|
— | 274 | — |
Investigational sites
Medical University Of Vienna
Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Waehringer Guertel 18-20, Alsergrund, Vienna
Ordensklinikum Linz GmbH
Internal Medicine IV, Seilerstaette 4, 4020, Linz
Vitaz
n/a, Moerlandstraat 1, 9100, Sint-Niklaas
UZ Leuven
Universitair Ziekenhuis Leuven, Herestraat 49, 3000, Leuven
Hopital Erasme
Cliniques Universitaires de Bruxelles Hopital Erasme, Lennikse Baan 808, 1070, Anderlecht
Az Maria Middelares Gent
AZ Maria Middelares, Buitenring-Sint-Denijs 30, 9000, Gent
CHU De Liège
CHU de Liege, Avenue De L'hopital 1, 4000, Liege
CHC MontLegia
Groupe Sante CHC - Clinique du MontLegia, Boulev. De Patience Et Beajonc 2, 4000, Liege
Az Delta
AZ-Delta, Deltalaan 1, 8800, Roeselare
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
N/A, Oborishte Distr., Ul.Byalo More 8, Sofia
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Department of Gastroenterology, Bulevard Gen. Stoletov No 67a, 1233, Sofia
Acibadem City Clinic Tokuda University Hospital EAD
N/A, Bulevard Nikola Yonkov Vaptsarov 51b, 1407, Sofiya
University Multiprofile Hospital For Active Treatment Kaspela EOOD
N/A, Zapaden District, Sofia Str 64, Plovdiv
Nemocnice Ceske Budejovice a.s.
Nemocnice Ceske Budejovice a.s., B. Nemcove 585/54, 370 01, Ceske Budejovice
Iscare a.s.
ISCARE a.s., Ceskomoravska 2510/19, Liben, Prague
NH Hospital a.s.
Nemocnice Horovice - NH Hospital a.s, Okruhova 1135/44, Stodulky, Prague 13
Chu De Saint Etienne
CHU de SAINT ETIENNE - Hopital Nord, 25 Boulevard Pasteur, 42055, Saint-Etienne Cedex 2
Nouvelles Cliniques Nimoises
Polyclinique Grand Sud, 3 Rue Jean Bouin, 30000, Nimes
Centre Hospitalier Universitaire De Toulouse
Hopital Universitaire Purpan Hopital Rangueil, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Hopital Saint Eloi
CHU Montpellier - Hôpital Saint Eloi, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Nice
CHU DE NICE-HOPITAL L’ARCHET II, 151 Route De Saint Antoine, 06200, Nice
Clinique Jules Verne
Clinique Jules Verne, Entree 2, 2 Route De Paris, Nantes
Centre Hospitalier Universitaire De Nantes
CHU de Nantes, Hotel Dieu -HME, 1 Place Alexis Ricordeau, 44000, Nantes
CHU Nancy - Hôpital Brabois
CHU DE NANCY - HÔPITAL BRABOIS ADULTES, Rue du Morvan, 54511, Vandoeuvre lès Nancy
Servicegesellschaft Krankenhaus Waldfriede mbH
Krankenhaus Waldfriede, Haus A 2, Argentinische Allee 40, Berlin
University Medical Centre Schleswig-Holstein
Universitaetsklinikum Schleswig-Holstein Campus Kiel, Arnold-Heller-Strasse 3, Brunswik, Kiel
Medical Center - University Of Freiburg
Universitaetsklinikum Freiburg, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Eugastro GmbH
EUGASTRO GmbH, Johannisplatz 1, Zentrum Sudost, Leipzig
Universitatsklinikum Erlangen AöR
Universitaetsklinikum Erlangen, Maximiliansplatz 2, Innenstadt, Erlangen
Hippokration Hospital
N/A, Vassilissas Sofias Avenue 114, 115 27, Athens
Thoracic General Hospital Of Athens I Sotiria
N/A, Messogion Avenue 152, 115 27, Athens
Evangelismos S.A.
N/A, Ipsiladou 45-47, 106 76, Athens
General Hospital of Nikaia-Piraeus “Agios Panteleimon”
N/A, Andrea Mantouvalou 3, 18454, PIREAUS
University General Hospital Of Heraklion
N/A, Stavrakia And Voutes, 715 00, Heraklion
Clinfan Szolgaltato Kft.
N/A, Pollack Mihaly utca 50., 7100, Szekszard
Clinexpert Kft.
N/A, Kaszasdulo Utca 5, 1033, Budapest III
Semmelweis University
n/a, Ulloi Ut 78, 1082, Budapest
University Of Szeged
N/A, Kalvaria Sugarut 57, 6725, Szeged
Azienda Ospedaliera Policlinico Universitario Tor Vergata
N/A, Viale Oxford 81, 00133, Rome
IRCCS Ospedale Policlinico San Martino
N/A, Largo Rosanna Benzi 10, 16132, Genoa
ASST Fatebenefratelli Sacco
N/A, Via Giovanni Battista Grassi 74, 20157, Milan
Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero
N/A, SS 554 km 4,500, 9042, Monserrato
San Camillo Forlanini Hospital
N/A, Circonvallazione Gianicolense 87, 00152, Rome
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
N/A, Via Trabucco 180, 90146, Palermo
ASST Rhodense/Presidio Ospedaliero di Rho
N/A, Corso Europa 250, 20017, Rho
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
N/A, Via Francesco Sforza 35, 20122, Milan
Academisch Medisch Centrum
N/A, Meibergdreef 9, 1105 AZ, Amsterdam
St. Elisabeth Hospital Tilburg
N/A, Hilvarenbeekseweg 60, 5022 GC, Tilburg
KM Management spol. s r.o.
gastroenterology, Hodzova 408/46, 949 01, Nitra
Fakultna Nemocnica S Poliklinikou Nove Zamky
N/A, Slovenska 11a, 940 02, Nove Zamky
F D Roosevelt University General Hospital Of Banska Bystrica
N/A, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica
Gastro I s.r.o.
N/A, Puskinova 18, 080 01, Presov
Hospital Clinico Universitario De Valencia
n/a, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Y Politecnico La Fe
n/a, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Virgen De La Macarena
n/a, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario De Fuenlabrada
n/a, Camino Del Molino 2, 28942, Fuenlabrada
Complexo Hospitalario Universitario De Santiago
n/a, Calle Choupana Da S/n, 15706, Santiago De Compostela
University Hospital Virgen Del Rocio S.L.
n/a, Avenida De Manuel Siurot S/n, 41013, Sevilla
Area Sanitaria De Ferrol
n/a, Avenida Residencia S/n, 15405, Ferrol
Hospital Universitario Puerta De Hierro De Majadahonda
n/a, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Universitario La Paz
n/a, Paseo Castellana 261, 28046, Madrid
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 | 2021-02-09 | 2021-08-10 | 2022-01-26 | ||
| Belgium | 2021-06-25 | 2021-09-13 | 2022-06-30 | ||
| Bulgaria | 2021-02-18 | 2021-03-15 | 2022-06-13 | ||
| Czechia | 2021-04-20 | 2021-06-02 | 2022-06-23 | ||
| France | 2021-06-25 | 2021-07-13 | 2022-06-29 | ||
| Germany | 2021-02-25 | 2021-03-03 | 2022-06-20 | ||
| Greece | 2021-03-02 | 2021-03-18 | 2022-06-22 | ||
| Hungary | 2021-02-05 | 2021-04-12 | 2022-06-09 | ||
| Italy | 2021-03-01 | 2021-04-26 | 2022-06-28 | ||
| Netherlands | 2021-02-24 | 2025-01-20 | 2021-04-19 | 2022-06-16 | |
| Poland | 2021-01-29 | 2021-03-16 | 2022-03-02 | ||
| Romania | 2021-03-21 | 2021-04-19 | 2022-06-17 | ||
| Slovakia | 2021-03-08 | 2021-03-25 | 2022-06-23 | ||
| Spain | 2020-11-25 | 2020-11-26 | 2022-06-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 156 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_m20259-protocol-redacted | 4 |
| Protocol (for publication) | D1_m20259-protocol-redacted-GR | 4 |
| Protocol (for publication) | m20259-patient-facing-ibdq public | 1 |
| Protocol (for publication) | m20259-patient-facing-sf-36-epro public | 1 |
| Protocol (for publication) | m20259-patient-facing-single-item-epro public | 1 |
| Protocol (for publication) | m20259-patient-facing-subject-daily-diary public | 1 |
| Recruitment arrangements (for publication) | K1_M20-259 AT EU CTR Recruitment and ICF Procedures - Study_public | 1 |
| Recruitment arrangements (for publication) | K1_M20-259 IT Recruitment and ICF Procedures | 2 |
| Recruitment arrangements (for publication) | K2_M20-259 AT text for local recruitment video DARMPLUS_public | 1 |
| Recruitment arrangements (for publication) | M20-259 BE Patient Brochure Dutch Public | 1 |
| Recruitment arrangements (for publication) | M20-259 BE Patient Brochure English Public | 1 |
| Recruitment arrangements (for publication) | M20-259 BE Patient Brochure French Public | 1 |
| Recruitment arrangements (for publication) | M20-259 BE Patient Flyer Dutch Public | 1 |
| Recruitment arrangements (for publication) | M20-259 BE Patient Flyer English Public | 1 |
| Recruitment arrangements (for publication) | M20-259 BE Patient Flyer French Public | 1 |
| Recruitment arrangements (for publication) | M20-259 BE Patient Welcome Guide PART 1 Dutch Public | 1 |
| Recruitment arrangements (for publication) | M20-259 BE Patient Welcome Guide PART 1 English Public | 1 |
| Recruitment arrangements (for publication) | M20-259 BE Patient Welcome Guide PART 1 French Public | 1 |
| Recruitment arrangements (for publication) | M20-259 BE Patient Welcome Guide PART 2 Dutch Public | 1 |
| Recruitment arrangements (for publication) | M20-259 BE Patient Welcome Guide PART 2 English Public | 1 |
| Recruitment arrangements (for publication) | M20-259 BE Patient Welcome Guide PART 2 French Public | 1 |
| Recruitment arrangements (for publication) | M20-259 BE Recruitment and ICF Procedures_Public | 1 |
| Recruitment arrangements (for publication) | M20-259 BE Recruitment Poster Dutch public | 1 |
| Recruitment arrangements (for publication) | M20-259 BE Recruitment Poster English public | 1 |
| Recruitment arrangements (for publication) | M20-259 BE Recruitment Poster French public | 1 |
| Recruitment arrangements (for publication) | M20-259 BG EU CTR Part II_Recruitment and ICF Procedures_public | 1.0 |
| Recruitment arrangements (for publication) | M20-259 BG_Patient Brochure_public | 1.0 |
| Recruitment arrangements (for publication) | M20-259 BG_Patient Brochure-public | 1.0 |
| Recruitment arrangements (for publication) | M20-259 BG_Patient Flyer_public | 1.0 |
| Recruitment arrangements (for publication) | M20-259 BG_Patient Flyer-public | 1.0 |
| Recruitment arrangements (for publication) | M20-259 BG_Patient Welcome Guide_PART2_public | 1.0 |
| Recruitment arrangements (for publication) | M20-259 BG_Patient Welcome Guide_PART2_public | 1.0 |
| Recruitment arrangements (for publication) | M20-259 BG_Patient Welcome Guide_public | 3.0 |
| Recruitment arrangements (for publication) | M20-259 BG_Patient Welcome Guide_public | 3.0 |
| Recruitment arrangements (for publication) | M20-259 CZ Patient Brochure public | 1 |
| Recruitment arrangements (for publication) | M20-259 CZ Patient Flyer public | 1 |
| Recruitment arrangements (for publication) | M20-259 CZ Patient Welcome Guide PART 1 public | 3 |
| Recruitment arrangements (for publication) | M20-259 CZ Patient Welcome Guide PART 2 public | 1 |
| Recruitment arrangements (for publication) | M20-259 CZ Recruitment and ICF Procedures-public | 1 |
| Recruitment arrangements (for publication) | M20-259 CZ Recruitment Poster public | 1 |
| Recruitment arrangements (for publication) | M20-259 DE Recruitment and ICF Procedures_public | 1 |
| Recruitment arrangements (for publication) | M20-259 DE Recruitment Brochure GER public | 1 |
| Recruitment arrangements (for publication) | M20-259 DE Recruitment Welcome Guide Part 1 Ger -public | 1 |
| Recruitment arrangements (for publication) | M20-259 ES Patient Brochure -public | 1 |
| Recruitment arrangements (for publication) | M20-259 EU CTR Part II Recruitment and ICF Procedures - Study -public | 1 |
| Recruitment arrangements (for publication) | M20-259 EU CTR Part II Recruitment and ICF Procedures_public | 2.0 |
| Recruitment arrangements (for publication) | M20-259 EU Recruitment and ICF Procedures -public | 1 |
| Recruitment arrangements (for publication) | M20-259 FR EU CTR Part II Recruitment and ICF Procedures-public | 1.0 |
| Recruitment arrangements (for publication) | M20-259 FR_posterflyer public | 1 |
| Recruitment arrangements (for publication) | M20-259 FR_Screen Shot website of study info_public | 1 |
| Recruitment arrangements (for publication) | M20-259 GR Recruitment and ICF Procedures - Study - public | 1 |
| Recruitment arrangements (for publication) | M20-259 IT Patient Brochure-public | 1.0 |
| Recruitment arrangements (for publication) | M20-259 IT Patient Flyer-public | 1.0 |
| Recruitment arrangements (for publication) | M20-259 IT Patient Poster-public | 1.0 |
| Recruitment arrangements (for publication) | M20-259 IT Patient Welcome Guide Part 1 -public | 3.0 |
| Recruitment arrangements (for publication) | M20-259 IT Patient Welcome Guide Part 2 -public | 1.0 |
| Recruitment arrangements (for publication) | M20-259 NL Patient Brochure-public | 1 |
| Recruitment arrangements (for publication) | M20-259 NL Patient Flyer -public | 1 |
| Recruitment arrangements (for publication) | M20-259 NL Patient Poster - public | 1 |
| Recruitment arrangements (for publication) | M20-259 NL Patient Welcome Guide part 1 -public | 3 |
| Recruitment arrangements (for publication) | M20-259 NL Patient Welcome Guide part 2 -public | 1 |
| Recruitment arrangements (for publication) | M20-259 NL Recruitment Procedure-public | 1 |
| Recruitment arrangements (for publication) | M20-259 SK Patient Welcome Guide PART 1 public | 3.0 |
| Recruitment arrangements (for publication) | M20-259 SK Patient Welcome Guide PART 2 public | 1.0 |
| Recruitment arrangements (for publication) | M20-259_GR Patient Brochure -public | 1 |
| Recruitment arrangements (for publication) | M20-259_GR Patient Flyer -public | 1 |
| Recruitment arrangements (for publication) | M20-259_GR Patient Welcome Guide -public | 3 |
| Recruitment arrangements (for publication) | M20-259_GR Patient Welcome Guide_PART2-public | 1 |
| Recruitment arrangements (for publication) | M20-259_GR Recuitment Poster -public | 1 |
| Recruitment arrangements (for publication) | M20-259_HU_Patient Welcome Guide -public | 1 |
| Recruitment arrangements (for publication) | M20-259_HU_Patient Welcome Guide_PART2 - public | 1 |
| Recruitment arrangements (for publication) | M20-259_PL-Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | M20-259_RO_Patient Brochure | 1 |
| Recruitment arrangements (for publication) | M20-259_RO_Patient Flyer | 1 |
| Recruitment arrangements (for publication) | M20-259_RO_Patient Welcome Guide Part 1 | 1 |
| Recruitment arrangements (for publication) | M20-259_RO_Patient Welcome Guide Part 2 | 1 |
| Recruitment arrangements (for publication) | M20-259_RO_Recruitment and ICF Procedures_public | 1 |
| Subject information and informed consent form (for publication) | L1 M20-259 CZ Main ICF_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1 M20-259 CZ Privacy ICF_Public | 5 |
| Subject information and informed consent form (for publication) | L1 M20-259 ES Main ICF_Public | 6.1 |
| Subject information and informed consent form (for publication) | L1 M20-259 ES Pregnant Partner ICF_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1 M20-259 FR Addendum ICF French_Public | 1 |
| Subject information and informed consent form (for publication) | L1 M20-259 SK Main ICF_Public | 5.1 |
| Subject information and informed consent form (for publication) | L1 M20-259 SK Privacy ICF_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1 M20-259 SK PTE Addendum_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1 M20-259_FR-ICF Main French_Public Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_M20-259 AT - ICF Main_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M20-259 AT - ICF Other IRB_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-259 HU_ICF MAIN_public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M20-259 IT ICF CTTP_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-259 IT ICF Optional_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-259 IT Pregnancy_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-259_AT blank document_ICF site contact details_public | 1 |
| Subject information and informed consent form (for publication) | L1_M20-259_BG_Main ICF Bulgarian Clean_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M20-259_BG_Main ICF English Clean_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M20-259_GR_ ICF Main_public | 6 |
| Subject information and informed consent form (for publication) | L1_M20-259_GR_ICF Optional PGenetic _public | 6.1 |
| Subject information and informed consent form (for publication) | L1_M20-259_PL_ICF Addendum_Public | 2 |
| Subject information and informed consent form (for publication) | L1_M20-259_PL_ICF Main_Public | 6 |
| Subject information and informed consent form (for publication) | L1_M20-259_RO_Addendum_PTE ICF_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_M20-259_RO-ICF Main Country Sample_Public | 5.0 |
| Subject information and informed consent form (for publication) | L2_M20-259_HU_Patient ID Card_Blank_Public | 3.0 |
| Subject information and informed consent form (for publication) | M20-259 BE CTE ICF Addendum_Dutch_Public | 2 |
| Subject information and informed consent form (for publication) | M20-259 BE CTE ICF Addendum_English_Public | 2 |
| Subject information and informed consent form (for publication) | M20-259 BE CTE ICF Addendum_French_Public | 2 |
| Subject information and informed consent form (for publication) | M20-259 CZ CTE Addendum public | 1 |
| Subject information and informed consent form (for publication) | M20-259 DE ICF CTE Addendum_public | 1.0 |
| Subject information and informed consent form (for publication) | M20-259 ES ICF Addend Country Sample Spanish -public | 1.0 |
| Subject information and informed consent form (for publication) | M20-259 GR Informed consent Addendum_CTTP-Public | 1 |
| Subject information and informed consent form (for publication) | M20-259 NL CTE ICF Addendum -public | 1.1 |
| Subject information and informed consent form (for publication) | M20-259_BE Main ICF_Dutch_Public | 12 |
| Subject information and informed consent form (for publication) | M20-259_BE Main ICF_English_Public | 12 |
| Subject information and informed consent form (for publication) | M20-259_BE Main ICF_French_Public | 12 |
| Subject information and informed consent form (for publication) | M20-259_BE Optional ICF_Dutch_Public | 6 |
| Subject information and informed consent form (for publication) | M20-259_BE Optional ICF_English_Public | 6 |
| Subject information and informed consent form (for publication) | M20-259_BE Optional ICF_French_Public | 6 |
| Subject information and informed consent form (for publication) | M20-259_BG CTE ICF Addendum_BG-Public | 1.0 |
| Subject information and informed consent form (for publication) | M20-259_BG CTE ICF Addendum_EN-public | 1.0 |
| Subject information and informed consent form (for publication) | M20-259_CZ-ICF Submission Informed Consent PharmacoGenetic_public | 2.0 |
| Subject information and informed consent form (for publication) | M20-259_DE-ICF Main_public | 5.1 |
| Subject information and informed consent form (for publication) | M20-259_DE-ICF Other Optional_public | 2.0 |
| Subject information and informed consent form (for publication) | M20-259_ES-ICF Other Optional_public | 2.0 |
| Subject information and informed consent form (for publication) | M20-259_GR -PregPart Informed Consent_public | 1 |
| Subject information and informed consent form (for publication) | M20-259_HU-ICF Main IRB Approved-_public | 3.0 |
| Subject information and informed consent form (for publication) | M20-259_HU-Informed Consent Patient Information Sheet_Optional Genetic_public | 1.0 |
| Subject information and informed consent form (for publication) | M20-259_HU-Informed Consent Supplementary COVID 19 Patient Information_public | 1.0 |
| Subject information and informed consent form (for publication) | M20-259_HU-Informed Consent_COVID 19_public | 1.0 |
| Subject information and informed consent form (for publication) | M20-259_HU-Informed Consent_Optional Genetic_ublic | 1.0 |
| Subject information and informed consent form (for publication) | M20-259_IT_Consent for COVID Emergency Procedures-public | 1 |
| Subject information and informed consent form (for publication) | M20-259_IT_ICF Privacy IRB Approved_public | 1 |
| Subject information and informed consent form (for publication) | M20-259_IT-ICF Main IRB_public | 1 |
| Subject information and informed consent form (for publication) | M20-259_IT-ICF Privacy IRB Approved_public | 1 |
| Subject information and informed consent form (for publication) | M20-259_NL Main ICF_public | 5.1 |
| Subject information and informed consent form (for publication) | M20-259_NL Optional ICF_public | 4 |
| Subject information and informed consent form (for publication) | M20-259_NL PregPart ICF_public | 3-1 |
| Subject information and informed consent form (for publication) | M20-259_NL-ICF Addend IRB Approved_public | 1-1 |
| Subject information and informed consent form (for publication) | M20-259_PL-ICF Other IRB Approved_public | 2 |
| Subject information and informed consent form (for publication) | M20-259_RO-ICF Main Country Sample_public | 1 |
| Subject information and informed consent form (for publication) | M20-259_SK-Informed Consent-_public | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | M20-259_smpc-stelara | 1 |
| Synopsis of the protocol (for publication) | D1-m20259-euctr-synopsis-bg-bg | 1 |
| Synopsis of the protocol (for publication) | D1-m20259-euctr-synopsis-cs-cz | 1 |
| Synopsis of the protocol (for publication) | D1-m20259-euctr-synopsis-de-be | 1 |
| Synopsis of the protocol (for publication) | D1-m20259-euctr-synopsis-el-el | 1 |
| Synopsis of the protocol (for publication) | D1-m20259-euctr-synopsis-en-en | 1 |
| Synopsis of the protocol (for publication) | D1-m20259-euctr-synopsis-es-es | 1 |
| Synopsis of the protocol (for publication) | D1-m20259-euctr-synopsis-fr-be | 1 |
| Synopsis of the protocol (for publication) | D1-m20259-euctr-synopsis-fr-fr | 1 |
| Synopsis of the protocol (for publication) | D1-m20259-euctr-synopsis-hu-hu | 1 |
| Synopsis of the protocol (for publication) | D1-m20259-euctr-synopsis-it-it | 1 |
| Synopsis of the protocol (for publication) | D1-m20259-euctr-synopsis-nl-be | 1 |
| Synopsis of the protocol (for publication) | D1-m20259-euctr-synopsis-pl-pl | 1 |
| Synopsis of the protocol (for publication) | D1-m20259-euctr-synopsis-ro-ro | 1 |
| Synopsis of the protocol (for publication) | D1-m20259-euctr-synopsis-sk-sk | 1 |
| Synopsis of the protocol (for publication) | D1-m20259-protocol synopsis-public-at-de | 4 |
| Synopsis of the protocol (for publication) | D1-m20259-protocol synopsis-public-hu | 4 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-15 | Romania | Acceptable 2023-06-06
|
2023-06-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-11 | Romania | Acceptable with conditions 2023-11-20
|
2023-11-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-11 | Romania | Acceptable 2025-02-03
|
2025-02-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-16 | 2025-07-17 | Romania | Acceptable 2025-09-15
|
2025-09-15 |
| 5 | SUBSTANTIAL MODIFICATION | SM-19 | 2026-02-06 | Romania | Acceptable 2026-04-21
|
2026-04-22 |