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Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease

RecruitingPhase 2Ages 18 Years - anyAllMadeleine Bezault
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In plain words

What the trial is, and whether it could suit you

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 readi

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📋 Eligibility rules (as published)
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 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 Criteria: * 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.
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What it tests

  • After surgery for Crohn's disease, 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
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Where

12 sites
CHU Clermont-Ferrand
Clermont-Ferrand, France
Hôpital Henri Mondor
Créteil, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
CHU Lille
Lille, France
Hospices civils Lyon Sud
Lyon, France
CHU Marseille Nord
Marseille, France
CHU Montpellier
Montpellier, France
CHU Nancy
Nancy, France

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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