Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT07463183 Sponsor: Merck Sharp & Dohme LLC Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT07463183
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 have had ulcerative colitis (a type of inflammatory bowel disease) for at least 3 months before the start of the trial
  • People whose ulcerative colitis is considered moderately to severely active
  • People who weigh at least 40 kg (approximately 88 pounds)
  • People who have previously tried one or more specified treatments that did not work well enough, stopped working over time, or caused side effects they could not tolerate — or who have become dependent on corticosteroids (confirm with trial site for the full list of qualifying treatments)
  • People who are currently taking certain specified medications and meet the stability requirements for those medications during the study (confirm with trial site for details)

Who may not be able to join:

  • People who have been diagnosed with Crohn's disease, indeterminate colitis, or other types of bowel or intestinal inflammation that could affect how results are measured
  • People who currently have a severe form of colitis known as fulminant colitis or a dangerous complication called toxic megacolon
  • People whose ulcerative colitis affects only the rectum
  • People who currently need, or are expected to soon need, a colostomy or ileostomy (a surgical opening to redirect the bowel)
  • People who have previously had surgery to remove all or part of the large bowel
  • People who were hospitalised due to a flare-up of their ulcerative colitis within 2 weeks before the screening stage of the trial
  • People who have an active infection of the type specified in the trial protocol (confirm with trial site for details)
  • People who are known to be infected with hepatitis B, hepatitis C, or HIV
  • People who have active tuberculosis (TB) or meet other TB-related exclusion conditions outlined in the protocol (confirm with trial site for details)
  • People who have a history of cancer within the last 5 years before the trial start — with the exception of certain fully treated skin cancers or a specific type of cervical cancer that was completely removed — or who have ever had colorectal cancer at any point
  • People who have, or have had, abnormal cell changes (dysplasia) in the colon, unless it was a low-grade finding that has been completely removed
  • People who have had a major surgery within 3 months before the screening stage, or who have a major surgery (one requiring general anaesthesia) planned during the trial period
  • People who have taken certain medications that are not permitted under the trial protocol (confirm with trial site for the full list)

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 27 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: Medical Director, Merck Sharp & Dohme LLC

Phone: 1-888-577-8839

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
24 March 2026
Est. completion
28 October 2027

Where this trial is recruiting

🇳🇱 Netherlands 🇰🇷 South Korea 🇺🇸 United States

Primary endpoints

Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12

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: 27 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