STARSCAPE-1

This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's disease (CD).

The study duration may be up to 35 weeks with:

• Up to 5-week 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).
• 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study.

The number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.

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 Crohn's disease (CD) 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 (ATs).

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

• Have ulcerative colitis (UC) or indeterminate colitis.
• Have two entire missing segments of the following:
  • Terminal ileum
  • Right colon transverse colon
  • Sigmoid and left colon
  • Rectum
• Have previously had or currently have high-grade gastrointestinal (GI) dysplasia.
• Have had treatment with, but not on stable doses of, conventional therapy prior to baseline.
• Have had prohibited medications or therapies.
• 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.