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An induction study to investigate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease
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 CD. Study details include:
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 enrol into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study.
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 enrol into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study.
What you need to know
Who can take part?
Inclusion Criteria:- Participants aged ≥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
- Confirmed diagnosis of moderately to severely active Crohn's Disease (CD) for at least 3 months prior to baseline
- Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)
- Exclusion Criteria:
- Participants with Ulcerative Colitis (UC) or indeterminate colitis
- Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum
- Prior or current high-grade gastrointestinal (GI) dysplasia
- Participants on treatment with but not on stable doses of conventional therapy prior to baseline
- Participants receiving prohibited medications or therapies
- Participants with previous exposure to anti-TL1A investigational therapy
What is involved for me?
- Regular study visits on site at Mater Hospital Brisbane (South Brisbane)
- Daily eDiary entries
- Blood, stool & urine tests at regular timepoints
- Colonoscopy at specified timepoints
- Injected study medication
