Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
59
Countries
2
Sites
6
Ulcerative Colitis
The objective of the study is to evaluate the long-term safety, tolerability, and maintenance of clinical response, of repeated administration of adalimumab in pediatric subjects with ulcerative colitis who participated in, and successfully completed, Protocol M11-290 through Week 52.
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 24 Nov 2015 → 9 Apr 2025
- Decision date (initial)
- 2024-02-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AbbVie Inc.
External identifiers
- EU CT number
- 2023-504711-32-00
- EudraCT number
- 2015-001346-29
- ClinicalTrials.gov
- NCT02632175
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
The objective of the study is to evaluate the long-term safety, tolerability, and maintenance of clinical response, of repeated administration of adalimumab in pediatric subjects with ulcerative colitis who participated in, and successfully completed, Protocol M11-290 through Week 52.
Secondary objectives 1
- Not applicable
Conditions and MedDRA coding
Ulcerative Colitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10045365 | Ulcerative colitis | 10017947 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Open label period 288-week open label maintenance period
|
Not Applicable | None | ||
| 2 | Follow-up period 70-day follow-up period
|
Not Applicable | None |
Regulatory references
- 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 https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
| EU CT number | Title | Sponsor |
|---|---|---|
| 2013-003032-77 | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis., Multicentrické, randomizované, dvojito zaslepené skúšanie humánnej Anti-TNF monoklonálnej protilátky Adalimumab u detských pacientov so stredne ťažkou až ťažkou ulceróznou kolitídou. , Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo del anticuerpo monoclonal humano anti-TNF Adalimumab en sujetos pediátricos con colitis ulcerosa moderada o grave, Multicentrické, randomizované, dvojitě zaslepené, placebem kontrolované klinické hodnocení zkoumající monoklonální protilátku adalimumab proti lidskému TNF u pediatrických pacientů se střední až těžkou ulcerózní kolitidou |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Subject must have successfully enrolled in and completed Protocol M11-290 through Week 52.
Exclusion criteria 1
- Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for continuing therapy in the Study M10-870.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- This study will utilize the PMS (and Mayo score if available) and PUCAI to determine efficacy of the study drug.
Secondary endpoints 1
- Safety analyses will be performed on all subjects who receive at least one dose of study drug.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
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
- 80 mg milligram(s)
- Max total dose
- 11520 mg milligram(s)
- Max treatment duration
- 288 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
- 80 mg milligram(s)
- Max total dose
- 11520 mg milligram(s)
- Max treatment duration
- 288 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 20 mg solution for injection in pre-filled syringe
PRD5952375 · Product
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 11520 mg milligram(s)
- Max treatment duration
- 288 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/03/256/022
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Humira 40 mg/0.8 ml solution for injection
PRD5952355 · Product
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 11520 mg/h milligram(s)/hour
- Max treatment duration
- 288 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB04 — -
- Marketing authorisation
- EU/1/03/256/001
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- 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 4
| Organisation | City, country | Duties |
|---|---|---|
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | E-data capture |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Laboratory analysis |
| Labcorp Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Interactive response technologies (IRT) |
| Clinipace Inc. ORG-100042162
|
Morrisville, United States | On site monitoring, Code 12 |
Locations
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 42 | 5 |
| Slovakia | Ended | 4 | 1 |
| Rest of world
United Kingdom, United States
|
— | 13 | — |
Investigational sites
Instytut Centrum Zdrowia Matki Polki
Klinika Gastroenterologii, Alergologii i Pediatrii, Ul. Rzgowska 281/289, 93-338, Lodz
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Pediatrii, Gastroenterologii i Żywienia, Ul. Marii Curie-Sklodowskiej 50/52, 50-369, Wroclaw
Eb Group Sp. z o.o.
., Ul. Inflancka 4a, 00-189, Warsaw
Uniwersytecki Szpital Dzieciecy W Krakowie
Klinika Pediatrii, Gastroenterologii i Żywienia, Ul. Wielicka 265, 30-663, Cracow
Gabinet Lekarski Bartosz Korczowski
., ul. Litewska 4A/7, 35-302, Rzeszów
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 |
|---|---|---|---|---|---|
| Poland | 2016-03-11 | 2025-04-08 | 2016-03-15 | 2019-08-28 | |
| Slovakia | 2015-11-24 | 2024-07-17 | 2015-11-25 | 2018-11-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| CTIS M10-870 Final Results SUM-99867
|
2025-09-29T23:14:11 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| m10870-results-lay-summary-en-en | 2025-09-29T20:08:39 | Submitted | Laypersons Summary of Results |
| m10870-results-lay-summary-pl-pl | 2025-09-29T20:08:57 | Submitted | Laypersons Summary of Results |
| m10870-results-lay-summary-sk-sk | 2025-09-29T20:09:07 | Submitted | Laypersons Summary of Results |
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | CTIS M10-870 Final CSR | 1 |
| Laypersons summary of results (for publication) | m10870-results-lay-summary-en-en | 1 |
| Laypersons summary of results (for publication) | m10870-results-lay-summary-pl-pl | 1 |
| Laypersons summary of results (for publication) | m10870-results-lay-summary-sk-sk | 1 |
| Protocol (for publication) | M10-870 Protocol-Public_Redacted | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC-adalimumab | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC-adalimumab-redlines | NA |
| Summary of results (for publication) | CTIS M10-870 Final Results 29SEP25 | 1 |
| Synopsis of the protocol (for publication) | M10-870 Protocol synopsis_ENG-Public | 5 |
| Synopsis of the protocol (for publication) | M10-870 Protocol synopsis_PL-Public | 5 |
| Synopsis of the protocol (for publication) | M10-870 Protocol synopsis_SK-Public | 5 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-15 | Poland | Acceptable 2024-01-30
|
2024-01-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-19 | Poland | Acceptable 2024-01-30
|
2024-03-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-07 | Poland | Acceptable 2025-06-08
|
2025-06-13 |