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NCT07184944 | RECRUITING | Crohn's Disease

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Sponsor:

Sanofi

Brief Summary:

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

Condition or disease

Crohn's Disease

Intervention/treatment

Duvakitug

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 671 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2026-01-29
Estimated Primary Completion Date : 2029-08-13
Estimated Study Completion Date : 2034-03-20

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 16 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 participant's potential participation in a clinical trial.
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

Location Details

NCT07184944

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Precision Clinical Research-Site Number: 8400059

Coral Springs, florida, United States, 33065

RECRUITING

United States, Florida

Regis Clinical Research, LLC-Site Number: 8400041

Miami, florida, United States, 33126

RECRUITING

United States, Florida

Correa Research Center-Site Number: 8400010

Miami, florida, United States, 33186