Crohn'sRecruiting
Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease
Phase 2 · 12 sites · Madeleine Bezault
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing an intervention as supportive care (to help with symptoms or quality of life). Condition(s) listed: Crohn Disease (CD).
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 1 more requirement(s). There are also 16 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 80 participants are expected to take part.
- Start date: 2025-03-31.
- Main results expected around 2026-09-13 (estimate from the record).
- 12 study sites listed (12 marked recruiting) in France.
Main thing being measured
- 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)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Crohn Disease (CD) |
| Lead sponsor | Madeleine Bezault |
| Enrollment | 80 (estimated) |
| Start date | 2025-03-31 |
| Primary completion (est.) | 2026-09-13 |
| First posted | 2025-04-13 |
| Last updated | 2025-09-17 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06925061 |
Interventions
- 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 (Drug)
Randomisation will be stratified on post-surgical treatment (none vs anti-TNF), and on smoking status (non-smoker vs smoker).
Full eligibility criteria (from the record)
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.
Locations (12)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.