M19-751 Phase 3 Risankizumab Pediatric Ulcerative Colitis
Research type
Research Study
Full title
A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab with Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) with Moderately to Severely Active Ulcerative Colitis.
IRAS ID
1012165
Contact name
Bernhard Dodell
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG B1-2
Eudract number
2024-514695-41
Clinicaltrials.gov Identifier
Research summary
Ulcerative colitis (UC) is a type of inflammatory bowel
disease that causes inflammation and bleeding from the
lining of the rectum and colon (large intestine). This study
will assess how Risankizumab moves through the body as
well as how safe and effective it is in treating pediatric
participants with moderate to severely active UC. Adverse
events and change in disease activity will be assessed.
Risankizumab is an approved medication for moderate to
severe UC in multiple countries and is being developed for
the treatment of UC in pediatrics. This study is comprised
of 3 cohorts that may participate in 3 substudies (SS).
Cohort 1 will enroll participants with ages from 6 to less
than 18 years. Cohort 2 will enroll participants with ages
from 2 to less than 6 years. Cohort 3 will enroll participants
with ages from 2 to less than 18 years. SS1 is an open-label
induction period where participants will receive a
weight-based induction regimen of risankizumab. SS2 is a
double-blind maintenance period where participants will be
randomized to receive 1 of 2 doses of weight-based
maintenance regimen of risankizumab. SS3 is an open-label
extension period where participants will receive
risankizumab based off of their response in SS2.
Around
120 pediatric participants with UC will be enrolled at
around 80 sites worldwide.
Participants in SS1 will receive risankizumab intravenously
during the 12-week induction period. Participants in SS2
will receive risankizumab subcutaneously during the
52-week randomized maintenance period. Participants in
SS3 will receive risankizumab subcutaneously during the
208-week open label period. Participants will be
followed-up for approximately 140 days.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
25/EE/0221
Date of REC Opinion
11 Dec 2025
REC opinion
Further Information Favourable Opinion