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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT05013905

NCT05013905
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have a confirmed diagnosis of Crohn's disease (CD)
  • Your Crohn's disease is considered moderately to severely active, based on a specific activity score and a camera examination of your bowel reviewed by a central medical team
  • You either depend on steroids to manage your condition, or you have not responded well to, lost response to, or could not tolerate at least one of the following treatments: steroids, immune-suppressing medications, or certain approved biologic therapies (such as anti-TNF, anti-integrin, or anti-IL-12/23 drugs)
  • You are able to give written consent and are willing and able to follow the requirements of the study

Who may not be able to join:

  • Women who could become pregnant, or men whose female partners could become pregnant, if they are unwilling to use two highly effective forms of contraception throughout the study and for up to 12 weeks after the last dose
  • You have been diagnosed with ulcerative colitis or a form of colitis that is unclear or unconfirmed
  • Your Crohn's disease only affects certain upper parts of your digestive system (stomach, duodenum, jejunum, or around the anus) without also involving the large or small intestine
  • You have a suspected or confirmed pocket of infection (abscess) inside your abdomen or around the anal area at the time of screening
  • You currently have or need a stoma bag (an opening in the abdomen to collect waste)
  • You have had surgical removal of more than 100 cm of small intestine in total, or removal of more than 2 sections of the large intestine
  • You have had bowel surgery within 3 months before the screening visit
  • You have current or past evidence of abnormal cell changes (dysplasia) in the colon that have not been fully removed
  • In the doctor's opinion, participating in the study would put you at an unacceptable health risk
  • Your blood or other laboratory test results do not meet the study's required levels (confirm with trial site)

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.

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.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Registry
clinicaltrials_gov
Start date
28 July 2021
Est. completion
23 September 2022

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇨🇿 Czechia 🇫🇷 France 🇬🇪 Georgia 🇵🇱 Poland 🇺🇸 United States

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Adverse Events; Serious Adverse Events; Adverse Events Leading to Discontinuation; Endoscopic Improvement

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov