Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT06925061 Sponsor: Madeleine Bezault Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT06925061
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years old or older at the time of signing the consent form.
  • You have been diagnosed with Crohn's disease affecting the small intestine (with or without the colon) for at least 3 months before the screening visit.
  • You have recently had surgery to remove part of your small intestine and the beginning of your large intestine (ileocecal resection), between 5 days and 5 weeks before being enrolled in the trial.
  • You are not planned to receive any Crohn's disease treatment after surgery, or you are planned to receive only a specific type of medication called anti-TNF agents, in the 6 months following surgery.

Who may not be able to join:

  • You have not sufficiently recovered from complications or side effects of your surgery before starting the trial treatment.
  • You currently have a stoma (an opening on your abdomen for waste), unless your bowel has already been reconnected (joining is possible within 5 weeks of reconnection).
  • You currently have an active anal fistula (an abnormal tunnel near the back passage).
  • You are planned to receive a type of biological therapy other than anti-TNF agents in the 6 months after surgery.
  • You have had more than 2 previous small bowel surgeries, or the total length of bowel removed in past surgeries adds up to more than 50 cm.
  • You have a medical reason why you cannot have an endoscopy (a camera procedure) or anaesthesia.
  • You are currently taking antibiotics, or it is likely you will need antibiotics within 6 weeks of starting the trial treatment.
  • You have a known allergy or sensitivity to the trial drug (EXL01), any of its ingredients, or soy/soy-based products (confirm with trial site for full ingredient list).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Matthieu Allez, Remind

Phone: +33(1) 57276817

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Madeleine Bezault
Registry
ClinicalTrials.gov
Start date
31 March 2025
Est. completion
13 September 2026

Where this trial is recruiting

🇫🇷 France

Primary endpoints

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.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov