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A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
NCT07184944 · Sanofi
In plain English
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Official 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
About this study
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include:
The study duration may be up to 286 weeks including:
* 40-week Pivotal Maintenance Sub-Study
* 240-week Open-Label Extension (OLE) Sub-Study
* 45-day Follow-Up visit
Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.
The treatment duration may be up to 280 weeks including:
* 40 weeks in the Pivotal Maintenance Sub-Study
* 240 weeks in OLE Sub-Study
The total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study
Eligibility criteria
Inclusion Criteria:
* Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to \<18 years of age who meet the definition of Tanner stage 5 for development)
* Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of STARSCAPE-1
* OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study
Exclusion Criteria:
* Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator
* Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Study design
Enrollment target: 671 participants
Allocation: randomized
Masking: quadruple
Age groups: child, adult, older_adult
Timeline
Starts: 2026-01-22
Estimated completion: 2034-03-20
Last updated: 2026-04-06
Interventions
Drug: DuvakitugDrug: Placebo
Primary outcomes
- • Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission (CDAI) at Week 40 (Week 40)
- • Proportion of participants achieving Endoscopic Response (SES-CD) at Week 40 (Week 40)
- • Co-primary endpoints EU/EMA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission per PRO-2 at Week 40 (Week 40)
Sponsor
Sanofi · industry
With: Teva Branded Pharmaceutical Products R&D LLC
Contacts & investigators
ContactTrial Transparency email recommended (Toll free for US & Canada) · contact · Contact-US@sanofi.com · 800-633-1610
All locations (7)
Clinical Research of Osceola-Site Number: 8400013Recruiting
Kissimmee, Florida, United States
Bioresearch Partner-Kendale Lakes-Site Number: 8400053Recruiting
Miami, Florida, United States
GI Alliance - Baton Rouge-Site Number: 8400129Recruiting
Baton Rouge, Louisiana, United States
New York Gastroenterology Associates-Site Number: 8400009Recruiting
New York, New York, United States
Ohio Gastroenterology Group Inc.-Site Number: 8400006Recruiting
Columbus, Ohio, United States
Tyler Research Institute LLC-Site Number: 8400095Recruiting
Tyler, Texas, United States
Investigational Site Number : 1240003Recruiting
Toronto, Canada