NCT06925061RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 17 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 30 Mar 2025
- Start date
- 31 Mar 2025
- Primary completion date
- 13 Sept 2026
- Lead sponsor
- Madeleine Bezault
- Diseases
- Crohn's disease
- NCT number
- NCT06925061
- EU CT number
- 2024-511357-22-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 31 Mar 2025 to the primary completion date, 13 Sept 2026
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has a not recovered adequately from any toxicity and/or complications from the surgery before the first dose of study intervention
- 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
- 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 not recovered adequately from any toxicity and/or complications from the surgery before the first dose of study intervention
- 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
- 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.
Other illness
- Has active anal fistula
- 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 active anal fistula
- 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.
Other
- Has a current stoma. Inclusion will be possible after continuity restoration (during the 5 weeks following continuity restoration)
- Has a contraindication to endoscopy or anaesthesia.
- Has a current stoma. Inclusion will be possible after continuity restoration (during the 5 weeks following continuity restoration)
- Has a contraindication to endoscopy or anaesthesia.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.