Tests EXL01 pill to prevent Crohn's disease returning after surgery
Tests oral EXL01 or placebo in adults with Crohn's disease after surgery.
Key facts
- Who runs it
- Madeleine Bezault
- Where
- Clermont-Ferrand, Créteil, Le Kremlin-Bicêtre, Lille, Lyon, Marseille, Montpellier, Nancy, Nantes, Nice, and Paris, FranceSee the 12 sites
- Trial code
- Registry title
- Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 80 people, planned
- Started
- 31 Mar 2025
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- 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
- Record updated
- 17 September 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Crohn's disease in the lower small bowel who had a bowel resection 5 days to 5 weeks ago. It tests oral EXL01 against placebo to prevent the disease returning.
- Age
- 18 years or older
- Sex
- Men and women can join
- Disease stage
- Crohn's disease with involvement of the ileum (ileal only or ileocolonic; L1 or L3 in Montreal classification), diagnosed at least 3 months before screening
- Earlier treatment
- Had an ileocecal resection or repeated ileo-colonic resection 5 days to 5 weeks before randomisation. Planned to get no Crohn's treatment or anti-TNF agents in the 6 months after surgery.
Main reasons for not taking part
- Has a stoma now (can join after the bowel is reconnected)
- Has an active anal fistula
- Had more than 2 past small bowel resections or more than 50 cm (20 in) of bowel removed in total
- Is planned to get a biotherapy other than anti-TNF in the 6 months after surgery
- Is on antibiotics or likely to need them within 6 weeks of the first dose
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- 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
Where in France
- CHU Clermont-FerrandClermont-Ferrand, FranceContact: Anthony BuissonTaking people
- Hopital Henri MondorCréteil, FranceContact: Mathieu UzzanTaking people
- Hopital BicetreLe Kremlin-Bicêtre, FranceContact: Franck CarbonnelTaking people
- CHU LilleLille, FranceContact: Pauline WilsTaking people
- Hospices civils Lyon SudLyon, FranceContact: Stéphane NanceyTaking people
- CHU Marseille NordMarseille, FranceContact: Mélanie SerreroTaking people
- CHU MontpellierMontpellier, FranceContact: Pierre BlancTaking people
- CHU NancyNancy, FranceContact: Bénédicte CaronTaking people
- CHU NantesNantes, FranceContact: Arnaud BoureilleTaking people
- CHU Nice Archet 2Nice, FranceContact: Xavier HebuterneTaking people
- CHU Saint LouisParis, FranceContact: Matthieu AllezTaking people
- Hôpital Saint-AntoineParis, FranceContact: Philippe SeksikTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Live biotherapeutic product (EXL01)Treatment being tested
EXL01 administered with or without SoC treatment orally, once a day during 24 weeks
Treatment: 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
- PlaceboPlacebo, for comparison
Placebo administered with or without SoC treatment orally, once a day during 24 weeks
Treatment: 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
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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
- Plain-language title
- Tests EXL01 pill to prevent Crohn's disease returning after surgeryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 17 September 2025