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.
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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

Matthieu Allez

+33(1) 57276817

matthieu.allez@aphp.fr

CONTACT