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

Part of paid clinical trials in Colorado Springs, Colorado.

Sponsor
Sanofi
Study ID
NCT07184944
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Duvakitug — DRUG
    Pharmaceutical form:Injection solution-Route of administration:SC injection
  • Placebo — DRUG
    Pharmaceutical form:Injection solution-Route of administration:SC injection

Study Details

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

Key Dates

First listed
Sep 22, 2025
Start date
Jan 22, 2026
Status verified
Jun 2026
Primary completion
Aug 13, 2029
Completion
Mar 20, 2034

Study Design

Enrollment
751 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Duvakitug dose 1
    Subcutaneous (SC) injection as per protocol
  • Experimental: Du vakitug dose 2
    SC injection as per protocol
  • Experimental: Du vakitug dose 3
    SC injection as per protocol
  • Placebo Comparator: Placebo
    SC injection as per protocol

Primary Outcome Measure

Co-primary endpoints US/FDA: Pivotal Maintenance Sub-Study Cohort 1 Proportion of participants achieving clinical remission (CDAI) at Week 40 [ Time Frame: Week 40 ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (22)

FacilityCityStateZIPSite coordinators
Peak Gastroenterology Associates - Colorado Springs-Site Number: 8400039Colorado SpringsColorado80907-
Clinical Research of Osceola-Site Number: 8400013KissimmeeFlorida34741-
Bioresearch Partner-Kendale Lakes-Site Number: 8400053MiamiFlorida33175-
NMC Research LLC-Site Number: 8400033TampaFlorida33607-
Gastroenterology Health Partners, PLLC - New Albany-Site Number: 8400100New AlbanyIndiana47150-
GI Alliance - Baton Rouge-Site Number: 8400129Baton RougeLouisiana70809-
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville-Site Number: 8400128MandevilleLouisiana70471-
Gateway Gastroenterology-Site Number: 8400097St LouisMissouri63141-
MedTraits NY-Site Number: 8400045MaspethNew York11378-
New York Gastroenterology Associates-Site Number: 8400009New YorkNew York10075-
NYU Langone Health-Site Number: 8400091New YorkNew York10016-
Weill Cornell Medicine - NewYork-Presbyterian Hospital-Site Number: 8400040New YorkNew York10065-
UNC Hospitals, The University of North Carolina at Chapel Hill-Site Number: 8400074Chapel HillNorth Carolina27514-
Cross Creek Medical Clinic-Site Number: 8400057FayettevilleNorth Carolina28304-
Ohio Gastroenterology Group Inc.-Site Number: 8400006ColumbusOhio43202-
OSU Wexner Medical Center-Site Number: 8400077ColumbusOhio43210-
North Shore Gastroenterology Research-Site Number: 8400130WestlakeOhio44145-
University of Pennsylvania School of Medicine-Site Number: 8400072PhiladelphiaPennsylvania19104-6243-
GI Alliance - Lubbock-Site Number: 8400092LubbockTexas79410-
Gastroenterology Research of San Antonio LLC-Site Number: 8400054San AntonioTexas78229-
Tyler Research Institute LLC-Site Number: 8400095TylerTexas75701-
Gastroenterology Associates of Western Michigan-Site Number: 8400060WyomingWyoming49519-

Find similar trials in Colorado Springs, CO

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Peak Gastroenterology Associates - Colorado Springs· Colorado Springs, COClinical Research of Osceola· Kissimmee, FLBioresearch Partner-Kendale Lakes· Miami, FLNMC Research LLC· Tampa, FLGastroenterology Health Partners, PLLC - New Albany· New Albany, INGI Alliance - Baton Rouge· Baton Rouge, LA

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