EFC18325 (SUNSCAPE-1 - UC Induction)
Research type
Research Study
Full title
A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis.
IRAS ID
1012892
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2025-521035-37
ISRCTN Number
-
Clinicaltrials.gov Identifier
-
Research summary
This (Induction Study [SUNSCAPE-1 or EFC18325]) Phase 3 is a randomised, double-blind, placebo-controlled study, and is being run to understand if duvakitug is safe and how well it works compared to placebo in participants with moderate to severe ulcerative colitis (UC). This study is comprised of Sub-Study 1, Sub-Study 2, and Sub-Study 3.
Participants in Sub-Study 1 will receive duvakitug. The participants and their doctors will know which medicine the participants are receiving.
The participants will be assigned to the treatment randomly in Sub-Study 2 and Sub-Study 3, meaning that the participants will be allocated to the treatment by chance. Participants in Sub-Study 2 will be assigned to receive either duvakitug or placebo (a look-alike to the study medication without an active medicine). Sub-Study 2 is double blinded meaning that it has been designed so that neither the participants nor the study doctor will know which study treatment the participants are receiving. Participants who do not achieve the expected treatment response in sub-studies 1 or 2, will have the opportunity to extend their treatment for 12 additional weeks via Sub-Study 3.
In Sub-Study 3, participants and their doctors will know which medicine they are receiving but will not know the assigned dose of the medicine. If participants do not respond to additional treatment, their participation in this study will end. If the participants respond to treatment in any of the 3 sub-studies, they may enroll in a long-term maintenance study (SUN-SCAPE-2).
The total study duration per participant may be up to 35 weeks, including up to 5-week Screening period, 2 possible treatment periods of 12-weeks each (Sub-Study 1/2 and 3) and a 45-day follow-up (only for participants who do not enroll into the maintenance Study).
The study will involve around 980 participants from approximately 500 centres worldwide.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
25/WM/0193
Date of REC Opinion
1 Dec 2025
REC opinion
Further Information Favourable Opinion