Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease
Recruiting
Phase 2
Interventional Study
Crohn Disease (CD)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 80 (estimated)
- Sponsor
- Madeleine Bezault · Other
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About This Trial
MAINTAIN-POP is a Phase 2, randomised, double-blind, placebo-controlled, multicenter study of the impact of oral administration of EXL01 in the prevention of post-operative endoscopic recurrence of Crohn's disease after surgery.
Approximately 80 eligible patients will be randomized 1:1 to receive oral EXL01 or placebo with or without SoC treatment (based on investigator decision) for up to 24 wee…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Is male or female aged ≥18 years at the time of providing documented informed consent.
* Has a diagnosis of CD with ileal involvement (ileal only or ileocolonic; L1 or L3 in Montreal classification) for at least 3 months prior to Screening.
* Has undergone an ileocecal resecti…
Contacts