Long-term safety and effectiveness of tulisokibart for Crohn's disease and ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This extension study aims to evaluate the long-term safety and efficacy of tulisokibart, a medication for treating active, moderate to severe Crohn's disease and ulcerative colitis. Participants who have previously taken tulisokibart in earlier studies will be invited to continue receiving the treatment to assess its ongoing benefits and tolerability. The study will monitor participants over time to gather data on the medication's safety profile and effectiveness in managing their conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Has participated in a qualifying tulisokibart parent study for CD or UC
* The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study
* A participant assigned female sex at birth is not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention
* A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention
* A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis)

Exclusion Criteria:

* Has prematurely discontinued study intervention in their parent study
* Has received any protocol-specified prohibited medications during their parent study
* Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Where it's running

• Connecticut Clinical Research Institute ( Site 0297)
  Bristol, Connecticut, United States Recruiting
• St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)
  Ypsilanti, Michigan, United States Recruiting
• BVL Research - Kansas ( Site 0292)
  Liberty, Missouri, United States Recruiting
• New York Gastroenterology Associates ( Site 0253)
  New York, New York, United States Recruiting
• GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)
  Garland, Texas, United States Recruiting
• GI Alliance - Lubbock ( Site 0288)
  Lubbock, Texas, United States Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• New treatments for adults with ulcerative colitis or Crohn's disease

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• Examining the link between polyamine levels and inflammatory bowel disease progression

  This study is trying to see if measuring certain substances in the body can help predict how inflammatory bowel diseases like Ulcerative Colitis and Crohn's Disease will progress in patients.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.