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RecruitingPhase 3

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Sanofi · with Teva Branded Pharmaceutical Products R&D LLC · NCT07185009

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 16–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
751
US sites recruiting
37
Study start
January 16, 2026
Record last updated
October 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC).

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 Pivotal Maintenance Sub-Study
  • 240 weeks in OLE Sub-Study

The total number of on-site visit will be up to 32:

  • 21 visits in the Pivotal Maintenance Sub-Study.
  • 11 visits in the OLE Sub-Study.

Being studied: Duvakitug; Placebo

Conditions: Ulcerative Colitis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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 SUNSCAPE-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.

Recruiting US locations

  • Del Sol Research Management, LLC - Site Number: 8400012

    Tucson, AZ 85715

  • Southern California GI & Liver Centers - Site Number: 8400062

    Coronado, CA 92118

  • United Medical Doctors CA - Site Number: 8400044

    Murrieta, CA 92563

  • Om Research, LLC - Victorville - Site Number: 8400022

    Victorville, CA 92395

  • Peak Gastroenterology Associates - Colorado Springs - Site Number: 8400039

    Colorado Springs, CO 80907

  • Clinical Research of Osceola - Site Number: 8400013

    Kissimmee, FL 34741

  • Bioresearch Partner-Kendale Lakes - Site Number: 8400053

    Miami, FL 33155

  • NMC Research LLC - Site Number: 8400033

    Tampa, FL 33607

  • Atlanta Gastroenterology Associates-Site Number: 8400109

    Atlanta, GA 30342

  • Grand Teton Research Group, PLLC-Site Number: 8400127

    Idaho Falls, ID 83404

  • GI Alliance - Gurnee-Site Number:

    Gurnee, IL 60031

  • Gastroenterology Health Partners, PLLC - New Albany - Site Number: 8400100

    New Albany, IN 47150

  • University of Kentucky Hospital/UK Albert B. Chandler Hospital-Site Number: 8400058

    Lexington, KY 40536-0293

  • GI Alliance - Baton Rouge - Site Number: 8400129

    Baton Rouge, LA 70809

  • Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance - Mandeville - Site Number: 8400128

    Mandeville, LA 70471

  • Delta Research Partners - Site Number: 8400087

    Monroe, LA 71291

  • UMass Memorial Medical Center-Site Number: 8400121

    Worcester, MA 01655

  • Gastroenterology Associates of Western Michigan - Site Number: 8400060

    Wyoming, MI 49519

  • Gateway Gastroenterology - Site Number: 8400097

    Chesterfield, MO 63017

  • BVL Clinical Research - Site Number: 8400005

    Liberty, MO 64068

  • Premier Health Research, LLC-Site Number: 8400114

    Sparta, NJ 07871

  • MedTraits NY - Site Number: 8400045

    Maspeth, NY 11378

  • NYU Langone Health-Site Number: 8400091

    New York, NY 10016

  • Weill Cornell Medicine - NewYork-Presbyterian Hospital - Site Number: 8400040

    New York, NY 10065

  • Lenox Hill Hospital-Site Number: 8400052

    New York, NY 10075

  • New York Gastroenterology Associates - Site Number: 8400009

    New York, NY 10075

  • Cross Creek Medical Clinic - Site Number: 8400057

    Fayetteville, NC 28304

  • Ohio Gastroenterology Group Inc. - Site Number: 8400006

    Columbus, OH 43202

  • North Shore Gastroenterology Research - Site Number: 8400130

    Westlake, OH 44145

  • The Allegheny Health Network (AHN) Center for Digestive Health-Site Number: 8400107

    Pittsburgh, PA 15212

  • University Gastroenterology-Site Number: 8400103

    Providence, RI 02904

  • One of a Kind Clinical Research Center TX, LLC-Site Number: 8400125

    Kingwood, TX 77339

  • GI Alliance - Lubbock - Site Number: 8400092

    Lubbock, TX 79410

  • Gastroenterology Research of San Antonio LLC - Site Number: 8400054

    San Antonio, TX 78229

  • Texas Digestive Disease Consultants, PLLC. dba GI Alliance - Southlake - Corporate Office - Site Number: 8400101

    Southlake, TX 76092

  • Tyler Research Institute, LLC - Site Number: 8400095

    Tyler, TX 75701

  • The Vancouver Clinic Inc. P.S. - Site Number: 8400090

    Vancouver, WA 98664

Study contacts (from the official record)

  • Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · contact-us@sanofi.com
A Maintenance Study to Investigate the Efficacy and Safety of… (NCT07185009) | Bored Studies