SUNSCAPE-1

Clinical Trial Title An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

National Clinical Trial Number: NCT07184996

Clinical Trial Protocol Description:

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

The study duration may be up to 35 weeks with the following:

Screening period
12-week Sub-Study 1 (Single-Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction)
12-week Sub-Study 3 (Extended Induction for non-responders)
45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359)
The treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

Are ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to <18 years of age who meet the definition of Tanner Stage 5 for development may participate.
Have a confirmed diagnosis of moderately to severely active UC for at least 3 months prior to Baseline.
Have demonstrated inadequate response and have shown loss of response or intolerance to conventional therapies or advanced therapies.

You will be excluded from the study if any of the following criteria apply to you:

Have with Crohn's disease (CD) and/or indeterminate colitis.
Have a current diagnosis of ulcerative proctitis.
Have had with surgical bowel resection within the past 3 months prior to Baseline, or have a history of >3 bowel resections.
Have previously had or currently have high-grade gastrointestinal (GI) dysplasia.
Have had treatment with, but not on stable doses of, conventional therapies prior to baseline.
Have had prohibited medications or therapies prior to baseline.
Have had previous exposure to anti-TL1A investigational therapy.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.