Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruiting
Participants planned
207
Countries
18
Sites
69
Ulcerative Colitis
To evaluate the safety and efficacy of lutikizumab compared to adalimumab in adult participants with moderately to severely active ulcerative colitis (UC).
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
- 19 Aug 2024 → ongoing
- Decision date (initial)
- 2024-07-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- AbbVie Inc.
External identifiers
- EU CT number
- 2023-505678-14-00
- ClinicalTrials.gov
- NCT06257875
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To evaluate the safety and efficacy of lutikizumab compared to adalimumab in adult participants with moderately to severely active ulcerative colitis (UC).
Secondary objectives 1
- Not Applicable
Conditions and MedDRA coding
Ulcerative Colitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10009900 | Colitis ulcerative | 100000004856 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- Yes
- IPD plan description
- AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participant has had a diagnosis of UC for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the investigator, must be available.
- Active UC with a Modified Mayo Score (mMS) of 5 to 9 points and Mayo Endoscopic Subscore (ESS) of 2 to 3 (confirmed by central review).
- Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunomodulators, and/or advanced therapies.
Exclusion criteria 3
- Current diagnosis of CD or inflammatory bowel disease-unclassified.
- Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
- Prior inadequate response, intolerance or loss of response to adalimumab (including biosimilars). Note: Subject may be enrolled if he/she discontinued adalimumab for reasons other than those listed above (e.g., loss of insurance) or if he/she has been exposed to other advanced therapies, including anti-TNFs other than adalimumab.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of Participants who Achieve Endoscopic Improvement at week 12
Secondary endpoints 3
- Percentage of Participants who Achieve Clinical Remission Per Modified Mayo Score (mMS) at week 12
- Percentage of Participants who Achieve Clinical Response Per mMS at week 12
- Percentage of Participants who Achieve Endoscopic Remission at week 12
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD2194826 · Product
- Active substance
- Lutikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
PRD10668516 · Product
- Active substance
- Lutikizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 5
Humira 80 mg solution for injection in pre-filled syringe
PRD5952373 · Product
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/03/256/020
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Humira 40 mg solution for injection in pre-filled syringe
PRD5952366 · Product
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/03/256/013
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Humira 40 mg solution for injection in pre-filled syringe
PRD5952368 · Product
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/03/256/015
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Humira 40 mg solution for injection in pre-filled syringe
PRD5952367 · Product
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/03/256/014
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Humira 40 mg solution for injection in pre-filled syringe
PRD5956777 · Product
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/03/256/012
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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 9
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Medical Equipment Supplies And Management Limited ORG-100044212
|
Chorley, United Kingdom | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Code 2 |
| Medable Inc. ORG-100043083
|
Palo Alto, United States | E-data capture |
| Q Squared Solutions Holdings LLC ORG-100043288
|
Durham, United States | Laboratory analysis |
| Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Interactive response technologies (IRT) |
| Alimentiv Inc. ORG-100006515
|
London, Canada | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Cytel Inc. ORG-100042560
|
Waltham, United States | Other |
Locations
18 EU/EEA countries · 69 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 3 | 3 |
| Belgium | Ended | 6 | 6 |
| Bulgaria | Ended | 7 | 7 |
| Croatia | Ongoing, recruitment ended | 11 | 5 |
| Estonia | Ongoing, recruitment ended | 4 | 4 |
| France | Ended | 5 | 5 |
| Germany | Ongoing, recruitment ended | 6 | 6 |
| Greece | Ongoing, recruitment ended | 4 | 4 |
| Hungary | Ended | 5 | 1 |
| Ireland | Ended | 2 | 2 |
| Italy | Ended | 4 | 4 |
| Latvia | Ended | 3 | 3 |
| Lithuania | Ongoing, recruitment ended | 9 | 3 |
| Netherlands | Not authorised | 2 | 2 |
| Norway | Ended | 2 | 2 |
| Poland | Ongoing, recruitment ended | 16 | 6 |
| Slovenia | Ended | 3 | 3 |
| Spain | Ongoing, recruitment ended | 4 | 3 |
| Rest of world
Argentina, Canada, Serbia, South Africa, Brazil, Puerto Rico, Japan, Turkey, Taiwan, Israel, Chile, Korea, Republic of, Egypt, United States, United Kingdom, Switzerland, Australia, New Zealand
|
— | 111 | — |
Investigational sites
Noe LGA Gesundheit Region Mitte GmbH
University Hospital St. Poelten, Department of Internal Medicine II, Dunant-Platz 1, 3100, St. Poelten
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
LKH Salzburg, Department of Internal Medicine I, Muellner Hauptstrasse 48, 5020, Salzburg
Medical University Of Vienna
Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Waehringer Guertel 18-20, Alsergrund, Vienna
UZ Leuven
Gastro Enterology, Herestraat 49, 3000, Leuven
Vitaz
Gastro Enterology, Moerlandstraat 1, 9100, Sint-Niklaas
Centre hospitalier universitaire de Liege
Gastro Enterology, Avenue De L'hopital 1, 4000, Liege
Hopital Erasme
Gastro Enterology, Lennikse Baan 808, 1070, Anderlecht
Universitair Ziekenhuis Gent
Gastro Enterology, Corneel Heymanslaan 10, 9000, Gent
Az Maria Middelares Gent
Gastro Enterology, Buitenring-Sint-Denijs 30, 9000, Gent
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Clinic of Gastroenterology, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia
Medicinski Centar Doverie AD
N/A, Friedrich Grunanger 2, 1632, Sofia
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Clinic of Gastroenterology, Oborishte Distr., Ul.Byalo More 8, Sofia
Second Multiprofile Hospital For Active Treatment Sofia EAD
Department of Gastroenterology in clinic of internal medicine, Bulevard Hristo Botev 120, 1202, Sofia
University Hospital St Marina Varna
Clinic of Gastroenterology, Hristo Smirnenski St 1, 9010, Varna
Acibadem City Clinic Diagnostic And Consultation Center Ltd.
Clinic of Gastroenterology, Bulevard Tsarigradsko Shose 66a, 1784, Sofia
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Department of Gastroenterology, Zapaden District, Sofia Str 64, Plovdiv
KBC Split
Department for gastroenterology, Spinciceva 1, 21000, Split
KBC Zagreb
Gastroenterology and Hepatology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Poliklinika Solmed d.o.o.
Department for gastroenterology, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
Poliklinika Borzan d.o.o.
Gastroenterology, Dubrovacka 12, 31000, Osijek
Specijalna Bolnica Medico
Department for gastroenterology, Agaticeva 8, 51000, Rijeka
Tartu University Hospital
Gastroenterology department, L. Puusepa Tn 1a, 50406, Tartu Linn
Laane-Tallinna Keskhaigla AS
Endoscopy department, Paldiski Mnt 68, 10617, Pohja-Tallinna Linnaosa
Sihtasutus Parnu Haigla
Endoscopy department, Ristiku Tn 1, 80010, Parnu Linn
Aktsiaselts Medicum Tervishoiuteenused
Medicum, Punane Tn 61, Lasnamae Linnaosa, Tallinn
Assistance Publique Hopitaux De Paris
Gastroenterology, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Centre Hospitalier Universitaire De Saint Etienne
Gastroenterology, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Centre Hospitalier Universitaire De Toulouse
Gastroenterology and Nutrition, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire De Nice
Gastroenterology and Nutrition, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Nantes
Gastroenterology, 1 Place Alexis Ricordeau, 44000, Nantes
Eugastro GmbH
N/A, Johannisplatz 1, Zentrum Sudost, Leipzig
Universitaetsklinikum Schleswig-Holstein AöR
N/A, Arnold-Heller-Strasse 3, Brunswik, Kiel
Klinikum rechts der Isar der TU Muenchen AöR
N/A, Ismaninger Strasse 22, Au-Haidhausen, Munich
University Medical Center Hamburg-Eppendorf
N/A, Martinistrasse 52, Eppendorf, Hamburg
St. Marien Und St. Annastiftskrankenhaus
N/A, Salzburger Strasse 15, Gartenstadt, Ludwigshafen Am Rhein
Universitaetsklinikum Ulm AöR
N/A, Albert-Einstein-Allee 23, Eselsberg, Ulm
University General Hospital Of Heraklion
Gastroenterology Department, Stavrakia And Voutes, 715 00, Heraklion
Thoracic General Hospital Of Athens I Sotiria
3rd University Internal Medicine Department, Messogion Avenue 152, 115 27, Athens
Evaggelismos Hospital
Gastroenterology Department, Ipsiladou 45-47, 106 76, Athens
Ippokratio General Hospital Of Thessaloniki
B’ Propaeudeutic Medicine Department, Konstadinoupoleos 49, 546 42, Thessaloniki
Clinexpert Kft.
N/A, Kaszasdulo Utca 5, 1033, Budapest III
Beaumont Hospital
Gastroenterology, Beaumont Road, Beaumont, Dublin 9
St Vincent's University Hospital
Gastroenterology, Nutley Lane Donnybrook, Elm Park, Dublin 4
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC CEMAD, Largo Francesco Vito 1, 00168, Rome
San Camillo Forlanini Hospital
UOC Gastroenterologia ed Endoscopia Digestiva Diagnostica ed Operativa, Circonvallazione Gianicolense 87, 00152, Rome
IRCCS Ospedale Sacro Cuore Don Calabria
Gastroenterologia ed endoscopia Digestiva, Via Don Angelo Sempreboni 5, 37024, Negrar
Azienda Ospedaliero-Universitaria Di Cagliari
UOC Gastroenterologia, Strada Statale 554 N. 1, 09042, Monserrato
Liepajas Regionala Slimnica SIA
Outpatient department, Slimnicas Iela 25, 3414, Liepaja
Pauls Stradins Clinical University Hospital
Center of Gastroenterology Hepatology and Nutrition, Pilsonu Iela 13, 1002, Riga
SIA Polana-D
Private practice, Viestura street 5, LV-5401, Daugavpils
Panevezys Republican Hospital VšĮ
Gastroenterology Department, Smelynes G. 25, Panevezio M. Sav., Panevezys
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Santaros Clinics, Santariskiu G 2, Vilniaus M. Sav., Vilnius
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Gastroenterology Department, Eiveniu G. 2, Kauno M. Sav., Kaunas
Radboud universitair medisch centrum / RADBOUDUMC
N/A, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Elisabeth-Tweesteden Ziekenhuis
N/A, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Akershus University Hospital
Department of Gastroenterology, Sykehusveien 25, 1474, Loerenskog
Universitetssykehuset Nord-Norge HF
Department of Gastroenterology, Sykehusvegen 38, 9019, Tromsoe
Centrum Medyczne Lukamed Sp. z o.o.
N/A, Ul. Mickiewicza 39, 89-600, Chojnice
H-T.Centrum Medyczne Sp. z o.o. sp.k.
N/A, Aleja Bielska 103a, 43-100, Tychy
Medrise Sp. z o.o.
N/A, Ul. Onyksowa 10, 20-582, Lublin
Centrum Opieki Zdrowotnej Orkan-Med Stec - Michalska Sp. j.
N/A, Ul. Wladyslawa Orkana 3, 95-054, Ksawerow
Melita Medical Sp. z o.o.
N/A, Ul. Strzegomska 2-4, 53-611, Wroclaw
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
N/A, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
Splosna Bolnisnica Murska Sobota
Department of internal medicine, Rakican, Ulica Dr. Vrbnjaka 6, Murska Sobota
University Medical Center Ljubljana
Clinical Department of Gastroenterology, Japljeva Ulica 2, 1000, Ljubljana
Splosna Bolnisnica Celje
Department for intestinal diseases, Oblakova Ulica 5, 3000, Celje
Complexo Hospitalario Universitario De Santiago
Digestive, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario La Paz
Digestive, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Virgen De La Macarena
Digestive, Avenida Del Doctor Fedriani 3, 41009, Sevilla
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 | 2024-12-18 | ||||
| Belgium | 2024-09-03 | 2025-01-13 | 2025-07-09 | ||
| Bulgaria | 2024-09-30 | 2024-12-20 | 2025-07-09 | ||
| Croatia | 2024-08-19 | 2024-08-26 | 2025-07-09 | ||
| Estonia | 2024-08-30 | 2025-01-20 | 2025-07-09 | ||
| France | 2024-08-29 | 2025-09-22 | 2024-11-19 | 2025-07-09 | |
| Germany | 2024-09-27 | 2024-10-16 | 2025-07-09 | ||
| Greece | 2024-11-14 | 2024-11-26 | 2025-07-09 | ||
| Hungary | 2024-08-30 | 2026-01-13 | 2024-10-24 | 2025-07-09 | |
| Ireland | 2024-11-25 | 2025-09-16 | 2025-04-14 | 2025-07-09 | |
| Italy | 2024-11-28 | 2025-01-29 | 2025-07-09 | ||
| Latvia | 2024-09-02 | 2025-02-04 | 2025-07-09 | ||
| Lithuania | 2024-09-25 | 2024-09-26 | 2025-07-09 | ||
| Norway | 2024-10-28 | 2025-07-31 | 2024-12-12 | 2025-07-09 | |
| Poland | 2024-08-27 | 2024-10-15 | 2025-07-09 | ||
| Slovenia | 2024-09-25 | 2025-07-30 | 2024-12-10 | 2025-07-09 | |
| Spain | 2024-09-18 | 2024-12-03 | 2025-07-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 168 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_M23-703 -Protocol Amend - Greek _Public Redacted | 4 |
| Protocol (for publication) | D1_m23703-protocol_Public Redacted | 4 |
| Protocol (for publication) | D1_m23703-protocol-admin-change | 6 |
| Recruitment arrangements (for publication) | K1 M23-703 NO Recruitment and ICF Procedures Public | 4 |
| Recruitment arrangements (for publication) | K1 M23-703 SI Recruitment and ICF Procedures Public | 2 |
| Recruitment arrangements (for publication) | K1_M23-703 AT Recruitment and ICF Procedures_public | 2.0 |
| Recruitment arrangements (for publication) | K1_M23-703 BE Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_M23-703 EE Recruitment and ICF Procedures_Public | 3 |
| Recruitment arrangements (for publication) | K1_M23-703 FR Recruitment and ICF Procedures_Public | 2 |
| Recruitment arrangements (for publication) | K1_M23-703 HR Recruitment and ICF Procedures Clean Public | 2 |
| Recruitment arrangements (for publication) | K1_M23-703 HU Recruitment and ICF Procedures_Public | 2 |
| Recruitment arrangements (for publication) | K1_M23-703 IT Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_M23-703 LV Recruitment and ICF Procedures_Public | 2 |
| Recruitment arrangements (for publication) | K1_M23-703 PL Recruitment and ICF Procedures_Public | 2 |
| Recruitment arrangements (for publication) | K1_M23-703_BG_Recruitment and ICF Procedure Clean_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_M23-703_DE_Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_M23-703_IE_Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K2 M23-703 IT Participant Brochure_Public | 2 |
| Recruitment arrangements (for publication) | K2 M23-703 IT Participant Flyer_Public | 2 |
| Recruitment arrangements (for publication) | K2 M23-703 IT Participant Poster_Public | 2 |
| Recruitment arrangements (for publication) | K2 M23-703 SI Recruitment Material - Brochure Public | V02 SVN01 |
| Recruitment arrangements (for publication) | K2 M23-703 SI Recruitment Material - Flyer Public | 02 |
| Recruitment arrangements (for publication) | K2 M23-703 SI Recruitment Material - Poster Public | 02 |
| Recruitment arrangements (for publication) | K2_M23-703 AT Advertisement and Recruitment Materials_Participant Brochure_public | 2 |
| Recruitment arrangements (for publication) | K2_M23-703 AT Advertisement and Recruitment Materials_Participant Poster_public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703 AT Advertisement and Recruitment Materials_Video Script Darmplus.at_addendum_public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-703 AT Advertisement and Recruitment Materials_Video Script Darmplus.at_public | 1.0 |
| Recruitment arrangements (for publication) | K2_M23-703 BE Dr to patient letter_Dutch | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703 BE Dr to patient letter_English | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703 BE Dr to patient letter_French | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703 BE Recruitment Brochure Dutch_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703 BE Recruitment Brochure English_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703 BE Recruitment Brochure French_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703 BE Recruitment Flyer Dutch_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703 BE Recruitment Flyer English_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703 BE Recruitment Flyer French_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703 BE Recruitment Poster Dutch_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703 BE Recruitment Poster English_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703 BE Recruitment Poster French_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703 HR Horizon Participant Brochure Public | V02HRV01 |
| Recruitment arrangements (for publication) | K2_M23-703 HR Horizon Participant Flyer Public | V02HRV01 |
| Recruitment arrangements (for publication) | K2_M23-703 HU Recruitment Brochure_Public | 2 |
| Recruitment arrangements (for publication) | K2_M23-703 IT Subject doctor letter_Public | 3 |
| Recruitment arrangements (for publication) | K2_M23-703 PL Dr to Patient Letter_Public | 2 |
| Recruitment arrangements (for publication) | K2_M23-703 PL Patient Brochure_Public | 2 |
| Recruitment arrangements (for publication) | K2_M23-703 PL Patient Flyer_Public | 2 |
| Recruitment arrangements (for publication) | K2_M23-703 PL Patient Poster_Public | 2 |
| Recruitment arrangements (for publication) | K2_M23-703_ IE_ Dr to patient letter_public | 3.0 |
| Recruitment arrangements (for publication) | K2_M23-703_BG_Recruitment Brochure Clean_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703_BG_Recruitment Flyer Clean_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703_DE_Doctor to Patient Letter_Public | 3.0 |
| Recruitment arrangements (for publication) | K2_M23-703_DE_Patient Brochure_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703_DE_Patient Flyer_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703_DE_Patient Poster_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703_EE_Patient Brochure_Estonian_Public | 02 |
| Recruitment arrangements (for publication) | K2_M23-703_EE_Patient Brochure_Russian_Public | 02 |
| Recruitment arrangements (for publication) | K2_M23-703_EE_Patient Flyer_Estonian_Public | 02 |
| Recruitment arrangements (for publication) | K2_M23-703_EE_Patient Flyer_Russian_Public | 02 |
| Recruitment arrangements (for publication) | K2_M23-703_EE_Patient Poster_Estonian_Public | 02 |
| Recruitment arrangements (for publication) | K2_M23-703_EE_Patient Poster_Russian_Public | 02 |
| Recruitment arrangements (for publication) | K2_M23-703_FR_Ad and Recruitment_Patient Brochure_French_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703_FR_Ad and Recruitment_Patient Flyer_French_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703_HR_Dr to patient letter_Public | 3.0 |
| Recruitment arrangements (for publication) | K2_M23-703_IE_Patient Brochure_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703_IE_Patient Flyer_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703_IE_Patient Poster_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M23-703_LV_Patient Brochure_Latvian_Public | 02 |
| Recruitment arrangements (for publication) | K2_M23-703_LV_Patient Brochure_Russian_Public | 02 |
| Recruitment arrangements (for publication) | K2_M23-703_LV_Patient Flyer_Latvian_Public | 02 |
| Recruitment arrangements (for publication) | K2_M23-703_LV_Patient Flyer_Russian_Public | 02 |
| Recruitment arrangements (for publication) | K2_M23-703_LV_Patient Poster_Latvian_Public | 02 |
| Recruitment arrangements (for publication) | K2_M23-703_LV_Patient Poster_Russian_Public | 02 |
| Recruitment arrangements (for publication) | K2_M23-703_NO_Patient Brochure_Public | 4 |
| Recruitment arrangements (for publication) | M23-703 ES Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | M23-703 LT Recruitment and ICF Procedures_Public | 1.0 |
| Recruitment arrangements (for publication) | M23-703_GR_EU CTR Recruitment and ICF Procedures_Public | 1 |
| Subject information and informed consent form (for publication) | EU CTR blank document | 1.0 |
| Subject information and informed consent form (for publication) | L1 M23-703 HU Main PIS and ICF Hungarian_Public Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1 M23-703 HU Mandatory Genetic ICF Hungarian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M23-703 HU Mandatory Genetic PIS Hungarian_Public Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1 M23-703 HU Optional Genetic ICF Hungarian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M23-703 HU Optional Genetic PIS Hungarian_Public Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1 M23-703 HU Optional LTE PIS and ICF Hungarian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ M23-703_DE_ICF_Main LTE_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 AT ICF LTE_public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 AT ICF Main_public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 AT ICF pregnant subject_public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 BE ICF LTE_Public_Dutch | 1.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 BE ICF LTE_Public_English | 1.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 BE ICF LTE_Public_French | 1.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 BE ICF Main_Public_Dutch | 4.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 BE ICF Main_Public_English | 4.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 BE ICF Main_public_French | 4.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 BE ICF Optional substudy_Public_Dutch | 2.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 BE ICF Optional substudy_public_English | 2.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 BE ICF Optional substudy_Public_French | 2.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 EE ICF Addendum LTE_Estonian_Public | 2.2 |
| Subject information and informed consent form (for publication) | L1_M23-703 EE ICF Addendum LTE_Russian_Public | 2.2 |
| Subject information and informed consent form (for publication) | L1_M23-703 EE ICF Main_Estonian_Public redacted | 3.2 |
| Subject information and informed consent form (for publication) | L1_M23-703 EE ICF Main_Russian_Public redacted | 3.2 |
| Subject information and informed consent form (for publication) | L1_M23-703 ES ICF Main_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 FR Main ICF_French_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 FR Optional LTE ICF_French_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_M23-703 GR ICF Main _public | 3 |
| Subject information and informed consent form (for publication) | L1_M23-703 HR ICF Addendum Public | 2 |
| Subject information and informed consent form (for publication) | L1_M23-703 IT ICF Main_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_M23-703 IT ICF Optional LTE_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_M23-703 IT ICF Optional_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_M23-703 IT ICF Pregnant data release_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_M23-703 LT ICF Main_Public Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_M23-703 LT ICF Optional LTE Addendum_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_M23-703 LT ICF Optional_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 LV ICF Main_Latvian_Public redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_M23-703 LV ICF Main_Russian_Public redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_M23-703 LV ICF Optional LTE Addendum_Latvian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 LV ICF Optional LTE Addendum_Russian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_M23-703 NO ICF Main_Public | 6 |
| Subject information and informed consent form (for publication) | L1_M23-703 NO ICF Optional LTE Addendum_Public | 3 |
| Subject information and informed consent form (for publication) | L1_M23-703 NO ICF Optional_public | 5 |
| Subject information and informed consent form (for publication) | L1_M23-703 PL ICF Addendum Treatment Continuation_Public | 2 |
| Subject information and informed consent form (for publication) | L1_M23-703 PL ICF Main_Public redacted | 4 |
| Subject information and informed consent form (for publication) | L1_M23-703 PL ICF Optional_Public | 3 |
| Subject information and informed consent form (for publication) | L1_M23-703 PL ICF Pregnancy_Public | 1 |
| Subject information and informed consent form (for publication) | L1_M23-703 SI Addendum ICF | 1 |
| Subject information and informed consent form (for publication) | L1_M23-703 SI ICF Main_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M23-703_ IE_ICF Addendum_Public | 1 |
| Subject information and informed consent form (for publication) | L1_M23-703_BG_ICF Addendum Bulgarian_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_M23-703_BG_ICF Addendum English_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_M23-703_BG_ICF Main Bulgarian Clean_Public Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M23-703_BG_ICF Main English Clean_Public Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M23-703_DE_ICF_Main_German_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M23-703_ES_Continued Treatment ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1_M23-703_ES_ICF_Optional ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1_M23-703_GR_ICF LTE_public | 2.1 |
| Subject information and informed consent form (for publication) | L1_M23-703_GR_ICF Optional Testing_Public | 2 |
| Subject information and informed consent form (for publication) | L1_M23-703_HR_ICF Main_Public | 6 |
| Subject information and informed consent form (for publication) | L1_M23-703_HR_ICF Optional_Public | 4 |
| Subject information and informed consent form (for publication) | L1_M23-703_HR_ICF_Pregnant subject_Public | 4 |
| Subject information and informed consent form (for publication) | L1_M23-703_IE ICF Main_Public | 4 |
| Subject information and informed consent form (for publication) | L2 M23-703 HU Patient ID Card_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2 M23-703 SI Biomarker Educational Material_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_M23-703_IE_Other Subject Information_public | 2.0 |
| Subject information and informed consent form (for publication) | M23-703 AT biomarker education_public | 1.0 |
| Subject information and informed consent form (for publication) | M23-703 BE Biomarker Educational Materials_Dutch | 1 |
| Subject information and informed consent form (for publication) | M23-703 BE Biomarker Educational Materials_English | 1 |
| Subject information and informed consent form (for publication) | M23-703 BE Biomarker Educational Materials_French | 1 |
| Subject information and informed consent form (for publication) | M23-703 BG Biomarker Educational Materials Bulgarian_Public | 1 |
| Subject information and informed consent form (for publication) | M23-703 BG Biomarker Educational Materials English_Public | 1 |
| Subject information and informed consent form (for publication) | M23-703 DE Biomarker Info Given to Subjects German_Public | 1 |
| Subject information and informed consent form (for publication) | M23-703 EE Info Given to Subjects_Estonian_Public | 1.0 |
| Subject information and informed consent form (for publication) | M23-703 EE Info Given to Subjects_Russian_Public | 1.0 |
| Subject information and informed consent form (for publication) | M23-703 ES Biomarker Educational Material_Public | 1 |
| Subject information and informed consent form (for publication) | M23-703 FR Biomarker Educational Material_Public | 1 |
| Subject information and informed consent form (for publication) | M23-703 GR Biomarker Info Given to Subjects_Greek_Public | 1 |
| Subject information and informed consent form (for publication) | M23-703 HU Biomarker Education Material Hungarian_Public | 1 |
| Subject information and informed consent form (for publication) | M23-703 IT Biomarker Educational Material_Public | 1 |
| Subject information and informed consent form (for publication) | M23-703 LT Info Given to Subjects _Public | 1.0 |
| Subject information and informed consent form (for publication) | M23-703 LV Info Given to Subjects_Latvian_Public | 1.0 |
| Subject information and informed consent form (for publication) | M23-703 LV Info Given to Subjects_Russian_Public | 1.0 |
| Subject information and informed consent form (for publication) | M23-703_HR_Biomarker Educational Material_Public | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC-humira-epar-product-information_en | 1 |
| Synopsis of the protocol (for publication) | D1_m23703-EU CTR-protocol-synopsis-EN | 1 |
| Synopsis of the protocol (for publication) | D1_m23703-EU CTR-protocol-synopsis-ES | 1 |
| Synopsis of the protocol (for publication) | D1_m23703-EU CTR-protocol-synopsis-GR | 1 |
| Synopsis of the protocol (for publication) | D1_m23703-EU CTR-protocol-synopsis-HU | 1 |
| Synopsis of the protocol (for publication) | D1_m23703-EU CTR-protocol-synopsis-LT | 1 |
| Synopsis of the protocol (for publication) | D1_m23703-EU CTR-protocol-synopsis-PL | 1 |
| Synopsis of the protocol (for publication) | D1_m23703-scientific-protocol-synopsis-HU | 4 |
Application history
20 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-02 | France | Acceptable 2024-07-22
|
2024-07-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-08-07 | Acceptable 2024-07-22
|
2024-08-07 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-16 | Acceptable | 2024-11-01 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-16 | Acceptable | 2024-09-13 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-16 | Acceptable | 2024-10-14 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-09-17 | Acceptable | 2024-09-24 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-14 | 2024-09-18 | Acceptable | 2024-10-02 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-09-19 | 2024-11-04 | ||
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-09-19 | Acceptable | 2024-10-24 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-11 | 2024-09-19 | Acceptable | 2024-10-30 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-12 | 2024-09-19 | Acceptable | 2024-11-27 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-09-20 | Acceptable | 2024-11-25 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-09-20 | Acceptable | 2024-10-25 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-09-20 | Acceptable | 2024-12-13 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-13 | 2024-09-20 | Acceptable | 2024-11-05 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-15 | 2024-09-20 | Acceptable | 2024-10-28 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-16 | 2024-09-20 | Acceptable | 2024-10-28 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-17 | 2024-09-24 | France | Acceptable | 2024-10-28 |
| 19 | SUBSTANTIAL MODIFICATION | SM-18 | 2025-03-07 | France | Acceptable 2025-06-11
|
2025-06-11 |
| 20 | SUBSTANTIAL MODIFICATION | SM-20 | 2025-09-26 | France | Acceptable 2025-12-31
|
2025-12-31 |