Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT06953791 Sponsor: University Hospital Tuebingen Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT06953791
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 Crohn's disease affecting the small intestine, or disease limited to the right or middle section of the large intestine, confirmed by a camera examination (endoscopy)
  • Your Crohn's disease activity score (CDAI) is 150 or above, meaning your disease is considered at least moderately active
  • You are taking a 5ASA medication or an immunomodulator (a drug that affects your immune system) that you have been on for more than 8 weeks at a stable dose, or you are starting a thiopurine (a type of immune-suppressing drug) at the same time as the trial
  • You are able to understand and sign the consent form before any study procedures begin
  • You are able to attend all required study visits and follow the study rules
  • You agree not to donate blood while taking the study medication
  • You agree not to share your study medication with anyone else
  • You are willing to use highly effective contraception during the treatment period and for 28 days after treatment ends (applies to both men and women)

Who may not be able to join:

  • Your Crohn's disease activity score (CDAI) is below 150 (very mild disease) or above 450 (very severe disease)
  • You have taken any steroid medication (such as prednisolone) in the past 4 weeks
  • You started an immunomodulator (immune-suppressing drug) within the past 8 weeks
  • You are currently receiving any biological therapy or certain newer targeted drug treatments
  • Your Crohn's disease only affects the lower or left section of the large intestine (descending colon or rectosigmoid area)
  • You have complications such as an abscess or a fistula (an abnormal tunnel or connection caused by the disease)
  • You have active disease around the anal area
  • You have a fixed narrowing (stricture) in your bowel or a bowel blockage
  • Your fecal calprotectin test (a stool test measuring bowel inflammation) is normal
  • You have active Crohn's-related disease outside the gut, such as joint problems
  • You have previously had part of your intestine surgically removed
  • You have a liver condition called sclerosing cholangitis
  • You have had an allergic reaction to the study drug or any similar medications or ingredients
  • You are currently pregnant or breastfeeding
  • You are currently taking part in another clinical trial or are within a waiting period from a previous trial

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: Karsten Büringer, MD, Head of Department of Inflammatory Bowel Disease/Endoscopy

Phone: +4970712961989

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 Hospital Tuebingen
Registry
ClinicalTrials.gov
Start date
1 February 2026
Est. completion
1 February 2028

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

Improvement of Quality of Life

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