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RecruitingPhase 3

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)

A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at the long-term safety of tulisokibart and how well people tolerate it. It is for people with Crohn’s disease or ulcerative colitis who took part in certain earlier tulisokibart studies and may benefit from continued treatment.

Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You took part in a qualifying Phase 2 or Phase 3 tulisokibart study for Crohn’s disease or ulcerative colitis.
  • The study doctor decides that continued treatment is helping you, based on checks during your earlier study.
  • If you were assigned female at birth, you must not breastfeed during treatment or for at least 14 weeks after your last dose.
  • If you can become pregnant, you must not be pregnant. You need a negative pregnancy test before your first dose: within 24 hours for a urine test or 72 hours for a blood test.
  • If you can become pregnant, you must use an accepted birth control method or continue your usual long-term choice not to have penis-in-vagina sex.

Who can't join

  • You stopped study treatment early in your earlier study.
  • You took medicines that were not allowed under the study rules during your earlier study.
  • You have a known allergy or sensitivity to tulisokibart or its ingredients, or you cannot tolerate them.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Has participated in a qualifying tulisokibart Phase 2 or Phase 3 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

Study sites (12)

CT

MI

MO

NY

TX

VA

WA