Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2025-12-24 @ 11:45 AM
NCT ID:
NCT06925061
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06925061
Study Brief:
Protocol Section:
NCT06925061