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

Purpose

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.

Condition

  • Ulcerative Colitis

Eligibility

Eligible Ages
Between 16 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Duvakitug - dose 1 		Subcutaneous (SC) injection as per protocol
  • Drug: Duvakitug
    Pharmaceutical form: Injection solution Route of administration: SC injection
Experimental
Duvakitug - dose 2 		SC injection as per protocol
  • Drug: Duvakitug
    Pharmaceutical form: Injection solution Route of administration: SC injection
Experimental
Duvakitug - dose 3 		SC injection as per protocol
  • Drug: Duvakitug
    Pharmaceutical form: Injection solution Route of administration: SC injection
Placebo Comparator
Placebo 		SC injection as per protocol
  • Drug: Placebo
    Pharmaceutical form:Injection solution-Route of administration:SC injection

Recruiting Locations

Royal Palm Clinical Research - Site Number: 8400065
Fort Myers, Florida 33901

Clinical Research of Osceola - Site Number: 8400013
Kissimmee, Florida 34741

Bioresearch Partner-Kendale Lakes - Site Number: 8400053
Miami, Florida 33155

GI Alliance - Baton Rouge - Site Number: 8400129
Baton Rouge, Louisiana 70809

Delta Research Partners - Site Number: 8400087
Monroe, Louisiana 71291

BVL Clinical Research - Site Number: 8400005
Liberty, Missouri 64068

New York Gastroenterology Associates - Site Number: 8400009
New York, New York 10075

Ohio Gastroenterology Group Inc. - Site Number: 8400006
Columbus, Ohio 43202

Tyler Research Institute, LLC - Site Number: 8400095
Tyler, Texas 75701

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
contact-us@sanofi.com