Phase 3 Crohn's Disease and Colitis Trial, Recruiting NCT06651281 Sponsor: Merck Sharp & Dohme LLC Condition: Crohn's Disease and Colitis
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Phase 3 Crohn's Disease and Colitis Trial, Recruiting

NCT06651281
Recruiting Phase 3

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 have already taken part in a qualifying Phase 2 or Phase 3 study of the drug tulisokibart for Crohn's disease or ulcerative colitis
  • Your doctor believes you are benefiting from continuing to take the study drug, based on how you have been doing in the previous study
  • If you were born female, you are not breastfeeding during the study and for at least 14 weeks after your last dose
  • If you could become pregnant, you have tested negative for pregnancy (via urine or blood test) within 24 or 72 hours before your first dose, depending on the type of test used
  • If you could become pregnant, you agree to use an acceptable form of contraception, or you consistently abstain from penile-vaginal intercourse as part of your usual lifestyle

Who may not be able to join:

  • You stopped taking the study drug early in your previous study (before you were supposed to finish)
  • You took any medications during your previous study that were listed as not allowed under that study's rules
  • You have a known allergy, sensitivity, or bad reaction to tulisokibart or any of its ingredients

⚠️ 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 20 July 2026
Phase 3: approximately ~65% 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 3
Registry
ClinicalTrials.gov
Start date
25 November 2024
Est. completion
17 December 2037

Where this trial is recruiting

🇨🇿 Czechia 🇫🇷 France 🇬🇪 Georgia 🇭🇺 Hungary 🇵🇱 Poland 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Number of Participants Who Experience an Adverse Event (AE); Number of Participants Who Discontinue Study Treatment Due to an AE

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: 20 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