Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease
A Phase 2 Multicentre, Randomised, Parallel-arm, Placebo-controlled, Double-blind Study to Evaluate the Safety and Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease
Madeleine Bezault
80 participants
Mar 31, 2025
INTERVENTIONAL
Conditions
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 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 weeks or until a study or treatment discontinuation criterion is met. Randomisation will be stratified on post-surgical treatment (none vs anti-TNF), and on smoking status (non-smoker vs smoker). The primary objective is to compare the distribution of endoscopic modified Rutgeerts scores, as centrally assessed, at 6 months post-surgery in patients with CD treated with EXL01 to patients treated with placebo. Endoscopic recurrence will be assessed using the endoscopic score assessed by central reading at Week 24 after surgery. All participants will be followed for safety until 4 weeks after end of treatment.
Eligibility
Inclusion Criteria4
- 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 Criteria16
- 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.
Interventions
Randomisation will be stratified on post-surgical treatment (none vs anti-TNF), and on smoking status (non-smoker vs smoker).
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT06925061