Target Engagement of EXL01 in the Prevention of Post-operative Recurrence of Crohn's Disease
NCT ID: NCT06925061
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-03-31
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease
NCT03464097
EXL01 in the Maintenance of Steroid-induced Clinical Response/Remission in Participants With Mild to Moderate Crohn's Disease
NCT05542355
Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal
NCT04997733
Evaluation of Therapeutic Strategy to Prevent Crohn's Disease Endoscopic poSToperatIve recurreNce Based on earlY Dosage of Faecal Calprotectin
NCT06972901
A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease
NCT04102111
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
After surgery for Crohn's disease, as per institutional Standard of Care (SoC), 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.. All patients will be monitored continuously for safety while on the study treatment. Endoscopic recurrence will be assessed using the endoscopic score assessed by central reading at Week 24 after surgery. Faecal and blood samples for biomarker assessments will be obtained at Weeks 0, 4, 12, and 24. Patients who experience disease flare before Week 24 will discontinue the study treatment (EXL01 or placebo) and undergo an early discontinuation (ED) visit. All participants will be followed for safety until 4 weeks after end of treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Live biotherapeutic product (EXL01)
EXL01 administered with or without SoC treatment orally, once a day during 24 weeks
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
Randomisation will be stratified on post-surgical treatment (none vs anti-TNF), and on smoking status (non-smoker vs smoker).
Placebo
Placebo administered with or without SoC treatment orally, once a day during 24 weeks
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
Randomisation will be stratified on post-surgical treatment (none vs anti-TNF), and on smoking status (non-smoker vs smoker).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Randomisation will be stratified on post-surgical treatment (none vs anti-TNF), and on smoking status (non-smoker vs smoker).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Madeleine Bezault
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Madeleine Bezault
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matthieu Allez
Role: PRINCIPAL_INVESTIGATOR
Remind
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Clermont-Ferrand
Clermont-Ferrand, , France
Hôpital Henri Mondor
Créteil, , France
Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
CHU Lille
Lille, , France
Hospices civils Lyon Sud
Lyon, , France
CHU Marseille Nord
Marseille, , France
CHU Montpellier
Montpellier, , France
CHU Nancy
Nancy, , France
CHU Nantes
Nantes, , France
CHU Nice Archet 2
Nice, , France
CHU Saint Louis
Paris, , France
Hôpital Saint Antoine
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-511357-22-00
Identifier Type: CTIS
Identifier Source: secondary_id
REMIND_2024-001_EXL01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.