Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT03901235 Sponsor: University of Liege Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT03901235
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:

  • People who are 18 years of age or older
  • People who agree to and sign a consent form to take part in the trial
  • People who have been diagnosed with Crohn's Disease for more than 6 months
  • People who have at least one Crohn's Disease problem area that has not responded to standard medicines (such as azathioprine, 6-mercaptopurine, or methotrexate) or to biological treatments (such as anti-TNF therapies, vedolizumab, or ustekinumab)
  • People whose treatment-resistant problem area is one of the following: a narrowing (stricture) of 2 to 5 cm in the colon or small intestine that can be reached by a colonoscopy camera; a deep, unhealed ulcer in the colon or small intestine reachable by colonoscopy; or one or more actively draining fistulas (abnormal tunnels) near the bottom/anal area
  • The trial is enrolling specific groups: 20 people with narrowings (strictures), 20 people with deep unhealed ulcers, and 20 people with actively draining perianal fistulas

Who may not be able to join:

  • People who need urgent bowel surgery right away
  • People who have a blockage in their intestines
  • People who have abnormal tunnels (fistulas) or a pocket of infection (abscess) inside the abdomen
  • People whose narrowing or deep ulcer cannot be reached by a colonoscopy camera
  • People who have an undrained abscess near the anal area
  • People who are pregnant or planning to become pregnant within one year
  • People who have a current bowel infection such as Clostridioides difficile or another identified infectious pathogen
  • People with serious kidney problems (such as very low kidney function, dialysis, or inability to pass urine) or serious liver problems (such as cirrhosis, liver failure, hepatitis, bleeding from the oesophagus, fluid build-up in the abdomen, or chronic viral hepatitis with high bilirubin levels — confirm with trial site for full details)
  • People with a confirmed HIV infection, or active hepatitis B, hepatitis C, or active tuberculosis
  • People who have had a serious opportunistic infection within the past 6 months, or any serious infection within the past 3 months
  • People who have had a cancer diagnosis within the past 5 years, or who have a history of a blood or lymph system cancer (lymphoproliferative disease)

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 22 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: Edouard Louis, Prof, Centre Hospitalier Universitaire de Liege

Phone: 043667256

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
University of Liege
Registry
ClinicalTrials.gov
Start date
15 January 2018
Est. completion
31 December 2025

Where this trial is recruiting

🇧🇪 Belgium

Primary endpoints

Proportion of patients with deep ulcer healing; Proportion of patients with stricture healing; Proportion of patients with complex perianal fistula healing; Safety assessed by the incidence of treatment-emergent adverse events during the study period

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: 22 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