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An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931

RecruitingPhase 3

Sponsor: Sanofi

Conditions: Crohn's Disease

Interventions: Duvakitug, Placebo

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include: The study duration may be up to 35 weeks with: * Up to 5-week Screening Period. * 12-week Sub-Study 1 (Single Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction). * 12-week Sub-Study 3 (Extended Induction for non-responders). * 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.

Eligibility overview

Sex: ALL

Age: 16 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \<18 years of age who meet the definition of Tanner Stage 5 for development
* Confirmed diagnosis of moderately to severely active Crohn's Disease (CD) for at least 3 months prior to baseline
* Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)

Exclusion Criteria:

* Participants with Ulcerative Colitis (UC) or indeterminate colitis
* Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum
* Prior or current high-grade gastrointestinal (GI) dysplasia
* Participants on treatment with but not on stable doses of conventional therapy prior to baseline
* Participants receiving prohibited medications or therapies
* Participants with previous exposure to anti-TL1A investigational therapy

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Locations (301)
  • Peoria, Arizona, United States
  • Scottsdale, Arizona, United States
  • Tucson, Arizona, United States
  • Little Rock, Arkansas, United States
  • Canoga Park, California, United States
  • Coronado, California, United States
  • Folsom, California, United States
  • Los Angeles, California, United States
  • Murrieta, California, United States
  • Rancho Cucamonga, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • San Diego, California, United States
  • Tarzana, California, United States
  • Thousand Oaks, California, United States
  • Valencia, California, United States
  • Victorville, California, United States
  • Colorado Springs, Colorado, United States
  • Denver, Colorado, United States
  • Clermont, Florida, United States
  • Coral Springs, Florida, United States
  • Gainesville, Florida, United States
  • Kissimmee, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • + 271 more on CT.gov