Phase 4 Crohn's Disease and Colitis Trial, Not Yet Recruiting NCT05976802 Sponsor: Bausch Health Americas, Inc. Condition: Crohn's Disease and Colitis
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Phase 4 Crohn's Disease and Colitis Trial, Not Yet Recruiting

NCT05976802
Not Yet Recruiting Phase 4

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 a boy or girl between 5 and 17 years old (not pregnant or breastfeeding) at the time of screening
  • You have been diagnosed with ulcerative colitis (UC), confirmed through a combination of your medical history, a camera examination of your bowel, and tissue samples taken from your bowel
  • Your ulcerative colitis only affects the lower part of the bowel and rectum (within the last 15 centimetres before the back passage)
  • Your ulcerative colitis is currently active and rated as mild or moderate severity, based on specific scoring measures used by doctors (confirm with trial site)
  • If you are already taking a type of medication called oral 5-ASA, your dose and type of medication must have stayed the same for at least 6 weeks before the study starts, and you are willing to keep taking it unchanged throughout the study

Who may not be able to join:

  • You have been diagnosed with Crohn's disease or a type of colitis that doctors could not clearly identify
  • Your ulcerative colitis affects higher-up parts of your bowel, beyond the lower section
  • Your ulcerative colitis is classed as severe based on your doctor's scoring
  • You currently have, or have recently had (within the last 30 days), a bowel infection confirmed by lab tests
  • You have had previous bowel surgery, unless it was only for an appendix removal or a hernia repair (a gallbladder removal more than 1 year ago is generally acceptable — confirm with trial site)
  • You have a history of a serious bowel complication called toxic megacolon, or you have had part of your bowel removed
  • You have active or historical problems in or around the back passage (such as haemorrhoids, fistulas, or fissures) that could make it difficult to receive medication rectally

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 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Varsha Bhatt, Bausch Health Americas, Inc.

Phone: 707-285-1528

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
Not Yet Recruiting
Phase
Phase 4
Sponsor
Bausch Health Americas, Inc.
Registry
ClinicalTrials.gov
Start date
1 June 2027
Est. completion
1 June 2029

Primary endpoints

Proportion of participants with clinical remission

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