EFC18359 (SUNSCAPE-2 - UC Maintenance)
Research type
Research Study
Full title
A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants with Moderately to Severely Active Ulcerative Colitis.
IRAS ID
1012895
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2025-521038-27
Research summary
This study (maintenance [SUNSCAPE-2 or EFC18359]) is a randomised, double-blind, placebo-controlled, Phase 3 study.
All participants who responded to duvakitug in induction study will join this study and receive treatment (placebo or duvakitug), that is randomly chosen for each participant, meaning it is determined by chance using a computer program. The placebo looks like the medicine being tested, but it does not have real medicine in it. Each participant can receive study treatment up to Week 40 where the participant or study doctor does not know which medication is given. This is called "Double-blind" (DB). 'Placebo-controlled' means some participants in the study may receive placebo treatment. Each participant who completes 40 weeks of treatment may be eligible to roll over to an open-label (OL) treatment period with the study medicine for up to 240 weeks. “Open-label” means that the participants and researchers both know which treatment is given. In case of worsening of symptoms, participants will be eligible for duvakitug rescue therapy.
The participants will be expected to participate in the study for up to 286 weeks; 40 weeks of DB treatment period, 240 weeks of OL treatment period and 45-day follow-up visit. Note that participant who does not participate in OL, duration will be up to 46 weeks, including 40-week DB treatment period and a 45-day follow-up visit.
The study will involve around 504 participants from approximately 40 centres worldwide.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
25/WM/0196
Date of REC Opinion
24 Nov 2025
REC opinion
Further Information Favourable Opinion