Preventing Crohn's disease recurrence after surgery with EXL01
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
This study is testing if a new oral medication called EXL01 can help prevent Crohn's disease from coming back after surgery in people who have just had an operation for it.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Saint-Louis Hospital, Paris, France Academic / other |
| Locations | 12 sites (Clermont-Ferrand and 11 other locations) |
| Trial ID | NCT06925061 on ClinicalTrials.gov |
What this trial studies
This Phase 2 clinical trial evaluates the effectiveness of oral EXL01 in preventing post-operative endoscopic recurrence of Crohn's disease. Approximately 80 patients who have undergone surgery for Crohn's disease will be randomly assigned to receive either EXL01 or a placebo for up to 24 weeks. The study aims to assess the endoscopic modified Rutgeerts scores at 6 months post-surgery to determine the impact of EXL01 compared to placebo. Participants will be monitored for safety throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone ileocecal or ileo-colonic resection for Crohn's disease and are not scheduled to receive anti-TNF agents post-surgery.
Not a fit: Patients who have not adequately recovered from surgery, have a current stoma, or are scheduled for biotherapy other than anti-TNF agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the recurrence of Crohn's disease after surgery, improving long-term patient outcomes.
How similar studies have performed: Other studies have explored similar approaches in managing Crohn's disease recurrence, but the specific use of EXL01 in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Clermont-Ferrand and 11 other locations
- 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)
Study contacts
- Principal investigator: Matthieu Allez — Remind
- Study coordinator: Matthieu Allez
- Email: matthieu.allez@aphp.fr
- Phone: +33(1) 57276817
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.