Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease

Inclusion Criteria:

• Is male or female aged ≥18 years at the time of providing documented informedconsent.

• Has a diagnosis of CD with ileal involvement (ileal only or ileocolonic; L1 or L3 inMontreal classification) for at least 3 months prior to Screening.

• Has undergone an ileocecal resection or iterative ileo-colonic resection, as perinstitutional SoC, between 5 days to 5 weeks before randomization.

• Is scheduled, in SoC context, to receive no treatment for CD or anti-TNF agents inthe 6 months after surgery

Exclusion Criteria:

• Has a not recovered adequately from any toxicity and/or complications from thesurgery before the first dose of study intervention

• Has a current stoma. Inclusion will be possible after continuity restoration (duringthe 5 weeks following continuity restoration)

• Has active anal fistula

• Is scheduled, according to SoC, to receive a biotherapy at the exception of anti-TNFagent in the 6 months after surgery

• Has had more than 2 past small bowel resections or cumulated intestinal resectionsuperior to 50 cm

• Has a contraindication to endoscopy or anaesthesia.

• Is receiving antibiotics at time of randomization or is likely to require antibiotictreatment within 6 weeks of the first dose of EXL01 or placebo.

• Has a history of hypersensitivity to EXL01 and/or any excipients, which are listedin the Investigator Brochure (IB), and/or to soybean or soy-containing products.

• Has a not recovered adequately from any toxicity and/or complications from thesurgery before the first dose of study intervention

• Has a current stoma. Inclusion will be possible after continuity restoration (duringthe 5 weeks following continuity restoration)

• Has active anal fistula

• Is scheduled, according to SoC, to receive a biotherapy at the exception of anti-TNFagent in the 6 months after surgery

• Has had more than 2 past small bowel resections or cumulated intestinal resectionsuperior to 50 cm

• Has a contraindication to endoscopy or anaesthesia.

• Is receiving antibiotics at time of randomization or is likely to require antibiotictreatment within 6 weeks of the first dose of EXL01 or placebo.

• Has a history of hypersensitivity to EXL01 and/or any excipients, which are listedin the Investigator Brochure (IB), and/or to soybean or soy-containing products.