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

NCT07185009

RecruitingPhase 3

Sponsor: Sanofi

Conditions: Ulcerative Colitis

Interventions: Duvakitug, Placebo

Countries: United States, Canada, Georgia, Japan, Lithuania, Poland, Serbia, Ukraine

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.

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 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.
Locations (46)
  • Tucson, Arizona, United States
  • Coronado, California, United States
  • Murrieta, California, United States
  • Victorville, California, United States
  • Colorado Springs, Colorado, United States
  • Fort Myers, Florida, United States
  • Kissimmee, Florida, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • New Albany, Indiana, United States
  • Baton Rouge, Louisiana, United States
  • Mandeville, Louisiana, United States
  • Monroe, Louisiana, United States
  • Wyoming, Michigan, United States
  • Chesterfield, Missouri, United States
  • Liberty, Missouri, United States
  • Maspeth, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Fayetteville, North Carolina, United States
  • Columbus, Ohio, United States
  • Columbus, Ohio, United States
  • Westlake, Ohio, United States
  • Lubbock, Texas, United States
  • San Antonio, Texas, United States
  • Southlake, Texas, United States
  • Tyler, Texas, United States
  • Vancouver, Washington, United States
  • Toronto, Ontario, Canada
  • Hamilton, Canada
  • + 16 more on CT.gov