Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease
Condition(s) studied
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: 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
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)
| Facility | City | Region | 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 |
Other trials for the same condition
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