EFC18327 (STARSCAPE-2 - CD 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 Crohn’s disease.
IRAS ID
1012894
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2025-521037-86
Research summary
This study (Maintenance Study [STARSCAPE-2 or EFC18327]) is for patients who completed the induction study STARSCAPE-1 (EFC18326) and showed improvement in symptoms of moderate to severe Crohn’s Disease (CD). This study aims to further test how safe and effective an experimental medication called duvakitug is at reducing the symptoms of (CD). Duvakitug works by blocking a protein that helps to reduce inflammation in the body.
This study is comprised of 2 sub-studies. Following a screening period, participants will be enrolled into the Pivotal Maintenance Sub-Study and will receive up to 40 weeks of treatment. After completing the Pivotal Maintenance Sub-Study, participants may be offered to continue treatment in an Open Label Extension [OLE] Sub-Study for an additional 240 weeks (60months). Participants will enter a follow-up period of 45 days after receiving their last treatment dose.
In the Pivotal Maintenance Sub-Study participants will receive either duvakitug or placebo, or alternate doses of duvakitug and placebo, every two weeks (there is a 67% chance of receiving duvakitug). Treatment is randomly chosen for each participant, meaning determined by chance using a computer program. Placebo looks like the medicine being tested, but it does not contain any real medicine in it. In the OLE Sub-Study, participants will receive duvakitug or placebo every 2 or 4 weeks, according to the dosing frequency in the previous Sub-Study. These doses will be administered under the skin by injections.
Participants will attend approximately 6 hospital visits (every 8 weeks) during the Pivotal Maintenance Sub-Study and approximately 11 hospital visits (every 6 months) during the OLE Sub-Study. Participants will 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.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
25/WM/0194
Date of REC Opinion
5 Dec 2025
REC opinion
Further Information Favourable Opinion