Actively Recruiting
Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease
Led by Madeleine Bezault · Updated on 2025-09-17
80
Participants Needed
12
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at consent
- Diagnosis of Crohn's disease involving the ileum or ileocolon for at least 3 months before screening
- Underwent ileocecal or ileocolonic resection between 5 days and 5 weeks before randomization
- Scheduled to receive no treatment or anti-TNF therapy for Crohn's disease in the 6 months after surgery
You will not qualify if you...
- Not fully recovered from surgery complications or toxicity before first study dose
- Current stoma, unless continuity restoration occurred within 5 weeks
- Active anal fistula
- Scheduled to receive biotherapy other than anti-TNF agents in 6 months after surgery
- More than 2 past small bowel resections or total intestinal resection over 50 cm
- Contraindication to endoscopy or anesthesia
- Receiving antibiotics at randomization or likely to need antibiotics within 6 weeks after first dose
- History of hypersensitivity to EXL01, its excipients, soybean, or soy-containing products
AI-Screening
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Trial Site Locations
Total: 12 locations
1
CHU Clermont-Ferrand
Clermont-Ferrand, France
Actively Recruiting
2
Hôpital Henri Mondor
Créteil, France
Actively Recruiting
3
Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
4
CHU Lille
Lille, France
Actively Recruiting
5
Hospices civils Lyon Sud
Lyon, France
Actively Recruiting
6
CHU Marseille Nord
Marseille, France
Actively Recruiting
7
CHU Montpellier
Montpellier, France
Actively Recruiting
8
CHU Nancy
Nancy, France
Actively Recruiting
9
CHU Nantes
Nantes, France
Actively Recruiting
10
CHU Nice Archet 2
Nice, France
Actively Recruiting
11
CHU Saint Louis
Paris, France, 75010
Actively Recruiting
12
Hôpital Saint Antoine
Paris, France, 75012
Actively Recruiting
Research Team
M
Matthieu Allez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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