Preventing Crohn's disease recurrence after surgery with EXL01

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Matthieu Allez — Remind
• Study coordinator: Matthieu Allez
• Email: matthieu.allez@aphp.fr
• Phone: +33(1) 57276817

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Reduce ultra-processed foods to help kids with Crohn's stay in remission longer

  This study tests whether and how reducing ultra-processed foods with dietitian guidance helps children and teens with Crohn's disease stay in remission longer.

  Recruiting University Hospital, Motol · Prague and 1 other locations · NCT07884045

• Endoscopic stricturotomy vs balloon dilation for small bowel Crohn’s stricture

  This trial tests whether endoscopic stricturotomy can be safely and effectively used to treat small bowel fibrotic strictures in Crohn’s disease, compared with endoscopic balloon dilation.

  Recruiting Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong · NCT07833332

• Prediction of postoperative recurrence in Crohn's disease after surgery

  A multicenter study will test a multimodal model to predict which Crohn's patients are likely to have disease recur after intestinal resection.

  Recruiting Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong · NCT07824791

• Perianal fistula imaging comparison using TPUS, MRI, EUS, and EUA

  This study tests how well four imaging methods—transperineal ultrasound, MRI, endoscopic ultrasound, and examination under anesthesia—detect and describe perianal fistulas in adults with Crohn's disease or unknown cause.

  Recruiting Asian Institute of Gastroenterology, India · Hyderabad, Telanagana · NCT07794410

• Familial IBD Early Risk

  This study tests whether clinical, environmental, and immune factors in first-degree relatives of people with Crohn’s disease or ulcerative colitis can predict who will develop IBD.

  Recruiting Seattle Children's Hospital · Seattle, Washington · NCT07791862

• Impact of sucralose on gut health in Crohn's disease

  This study tests whether the non-nutritive sweetener sucralose changes gut bacteria in adults with Crohn's disease compared to healthy controls.

  Recruiting at 3 sites University Hospitals Cleveland Medical Center · Chagrin Falls, Ohio and 2 other locations · NCT07769437

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.