A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Recruiting
Phase 3
Interventional Study
Crohn's Disease
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 751 (estimated)
- Sponsor
- Sanofi · Industry
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About This Trial
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). 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-…
Trial Locations
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Eligibility Criteria
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 endosc…
Contacts
Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
CONTACT