Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT04373473 Sponsor: The University of Texas Health Science Center, Houston Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT04373473
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 aged 18 or older
  • People who have had active ulcerative colitis (a type of inflammatory bowel disease) at some point in the past 12 months, confirmed through standard medical assessments
  • People whose ulcerative colitis is currently in remission (symptoms are well controlled) based on a standard scoring system, and who are on a stable ongoing treatment plan
  • People who are sexually active and able to have children must agree to use an effective form of birth control for the duration of the study
  • Women who are able to become pregnant must have a negative pregnancy test at enrolment and again before the first dose of the study treatment
  • People who are willing and able to sign a consent form and attend all required clinic visits, assessments, and follow-up phone calls
  • People who have a regular doctor who will manage their non-study-related care during the trial

Who may not be able to join:

  • People who are unable to swallow multiple capsules by mouth
  • Women who are pregnant, breastfeeding, or planning to become pregnant during the study
  • People who have taken antibiotic tablets or injections (not creams or topical treatments) within 14 days before the first treatment day
  • People with a current active HIV, Hepatitis B, or Hepatitis C infection
  • People who have had recurring Clostridioides difficile (a type of gut infection) or a faecal microbiota transplant (a gut bacteria treatment) within the past 6 months
  • People with other ongoing gut or digestive conditions, such as irritable bowel syndrome, coeliac disease, diverticulitis, or those who have had surgical removal or diversion of part of the bowel, among others
  • People with a known history of bile acid diarrhoea (a condition where the digestive system produces too much bile, causing diarrhoea)
  • People with a weakened immune system, whether due to a medical condition or medications — for example, those taking more than 20 mg per day of prednisone or an equivalent steroid medication
  • People with a history of active cancer or who are currently undergoing chemotherapy (though people with certain minor, non-spreading cancers or on maintenance chemotherapy may still be considered — confirm with trial site)
  • People who have taken part in another clinical trial involving an experimental drug within the past 90 days
  • People with a serious uncontrolled medical condition that, in the trial doctor's view, could interfere with taking part in the study
  • People with a life expectancy of less than one year
  • People the trial investigator determines should be excluded for any other reason (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.

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 21 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

Phone: 713 500 6687

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
Registry
ClinicalTrials.gov
Start date
14 September 2020
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Patients in remission after administering 12 weeks of PRIM-DJ2727 capsules will be measured by partial Mayo score ≤ 3

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: 21 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