Ireland
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Recruiting Phase 2

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

NCT06925061 · tracked via the Priya Life Science France tracker
Sponsor
Madeleine Bezault
Phase
Phase 2
Started
2025-03-31
Last updated
2025-09-17

Condition(s) studied

Crohn Disease (CD)

Investigational drug(s) / intervention(s)

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

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: Randomisation will be stratified on post-surgical treatment (none vs anti-TNF), and on smoking status (non-smoker vs smoker).

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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. — From enrollment to the end of treatment at 24 weeks
    Evaluation of the distribution of modified Rutgeerts score grouped in 4 categories (i0: No lesions in the neoterminal ileum, i1: ≤ 5 ulcerations in the neoterminal ileum - i2a: Isolated anastomotic ulceration, i2b: \>5 ulcerations in the neoterminal ileum, i3: Diffuse ileitis - i4: Diffuse ileitis with deep ulcerations and/or stenosis) at Week 24/EOT, evaluated by endoscopy with video capture, and assessed by BICR.

Trial sites (12)

FacilityCityRegionStatus
CHU Clermont-Ferrand Clermont-Ferrand France Recruiting
Hôpital Henri Mondor Créteil France Recruiting
Hôpital Bicêtre Le Kremlin-Bicêtre France Recruiting
CHU Lille Lille France Recruiting
Hospices civils Lyon Sud Lyon France Recruiting
CHU Marseille Nord Marseille France Recruiting
CHU Montpellier Montpellier France Recruiting
CHU Nancy Nancy France Recruiting
CHU Nantes Nantes France Recruiting
CHU Nice Archet 2 Nice France Recruiting
CHU Saint Louis Paris France Recruiting
Hôpital Saint Antoine Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06925061 on ClinicalTrials.gov ↗ ← All trials in France