Status:
RECRUITING
Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease
Lead Sponsor:
Madeleine Bezault
Conditions:
Crohn Disease (CD)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 Cr...
Detailed Description
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 Cr...
Eligibility Criteria
Inclusion
- 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 resection or iterative ileo-colonic resection, as per institutional SoC, between 5 days to 5 weeks before randomization.
- Is scheduled, in SoC context, to receive no treatment for CD or anti-TNF agents in the 6 months after surgery
Exclusion
- Has a not recovered adequately from any toxicity and/or complications from the surgery before the first dose of study intervention
- Has a current stoma. Inclusion will be possible after continuity restoration (during the 5 weeks following continuity restoration)
- Has active anal fistula
- Is scheduled, according to SoC, to receive a biotherapy at the exception of anti-TNF agent in the 6 months after surgery
- Has had more than 2 past small bowel resections or cumulated intestinal resection superior to 50 cm
- Has a contraindication to endoscopy or anaesthesia.
- Is receiving antibiotics at time of randomization or is likely to require antibiotic treatment within 6 weeks of the first dose of EXL01 or placebo.
- Has a history of hypersensitivity to EXL01 and/or any excipients, which are listed in the Investigator Brochure (IB), and/or to soybean or soy-containing products.
- Has a not recovered adequately from any toxicity and/or complications from the surgery before the first dose of study intervention
- Has a current stoma. Inclusion will be possible after continuity restoration (during the 5 weeks following continuity restoration)
- Has active anal fistula
- Is scheduled, according to SoC, to receive a biotherapy at the exception of anti-TNF agent in the 6 months after surgery
- Has had more than 2 past small bowel resections or cumulated intestinal resection superior to 50 cm
- Has a contraindication to endoscopy or anaesthesia.
- Is receiving antibiotics at time of randomization or is likely to require antibiotic treatment within 6 weeks of the first dose of EXL01 or placebo.
- Has a history of hypersensitivity to EXL01 and/or any excipients, which are listed in the Investigator Brochure (IB), and/or to soybean or soy-containing products.
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06925061
Start Date
March 31 2025
End Date
December 31 2026
Last Update
September 17 2025
Active Locations (12)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France
2
Hôpital Henri Mondor
Créteil, France
3
Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94270
4
CHU Lille
Lille, France