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

Evaluating Efficacy and Safety of Investigational Medication in Moderately to Severely Active Ulcerative Colitis

Recruiting
16 years - 80 years
All
Phase 3
671 participants needed
21 Locations

Study Overview

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 Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ulcerative Colitis
  • Age: 16 years - 80 years
  • Gender: All

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.

This study investigates moderately to severely active ulcerative colitis. It focuses on evaluating the safety and effectiveness of an investigational medication.

The study evaluates how well the investigational medication works and how safe it is for people with this condition.

  • Who can participate: Participants aged 18 to 80 years, and those 16 to 18 years meeting specific developmental criteria, may join. Key factors include having completed certain prior studies and a clinical response.
  • Study details: Participants aged 18 to 80 years, and those 16 to 18 years meeting specific developmental criteria, may join. Key factors include having completed certain prior studies and a clinical response. Participants will take the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study requires 32 visits and will last up to 286 weeks for some participants and up to 46 weeks for others.
  • Study visits: The study requires 32 visits.
Updated on 20 May 2026. Study ID: NCT07185009

Find a study site near you

We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
United States Only: Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language