EFC18326 (STARSCAPE-1 - CD 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 Crohn’s Disease
IRAS ID
1012893
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2025-521036-11
ISRCTN Number
-
Clinicaltrials.gov Identifier
-
Research summary
This study (Induction Study [STARSCAPE-1 or EFC18326]) aims to test how safe and effective an experimental medication called duvakitug is at reducing the symptoms of Chron’s Disease (CD). Duvakitug works by blocking a protein that helps to reduce inflammation in the body.
This study is comprised of 3 sub-studies. Following a screening period, participants will be enrolled into either Sub-Study 1 or Sub-Study 2 and will receive 12 weeks of treatment. Participants that do not achieve the expected response, will have the opportunity to extend treatment for 12 additional weeks in Sub-Study 3. If participants do not respond to additional treatment their participation in this study will end. After completing treatment in this study, participants may be offered to continue treatment in a Maintenance Study (STARSCAPE-2). Participants who do not continue onto the maintenance study will enter a follow-up period of 45 days.
In Sub-Study 1 participants will all receive the same dose of duvakitug. For Sub-Study 2 and 3, treatment is randomly chosen for each participant, meaning determined by chance using a computer program. In Sub-Study 2 participants will be randomly assigned to receive either one of two doses of duvakitug or placebo (there is a 67% chance of receiving duvakitug). Placebo looks like the medicine being tested, but it does not contain any real medicine in it. In Sub-Study 3 participants will receive one of two doses of duvakitug. These doses will be administered under the skin by injections.
Participants will attend approximately 10 hospital visits during this study and undergo several assessments, including physical examinations, collection of blood, urine and stool samples, questionnaires, eDiary completion, electrocardiograms, endoscopy and biopsies.
This study is sponsored by Sanofi-Aventis Recherche & Développement and is taking place in approximately 41 countries. It is planned to start in October 2025.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
25/WM/0195
Date of REC Opinion
27 Nov 2025
REC opinion
Further Information Favourable Opinion