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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.