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MK-7240

  • Status
    Accepting Candidates
  • Age
    16 Years - 80 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12.

Description

The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.

Details

Full study title A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of MK-7240 in Participants with Moderately to Severely Active Ulcerative Colitis
Protocol number OCR45383
ClinicalTrials.gov ID NCT06052059
Phase Phase 3

Eligibility

Inclusion Criteria:

  • Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before randomization

  • Has moderately to severely active UC

  • Weight 鈮�40 kg

  • Satisfies at least 1 of the following criteria:

    • Has had an inadequate response or loss of response to 1 or more protocol-specified UC treatments

    • Protocol specified corticosteroid dependence

    • Has been intolerant to 1 or more protocol-specified UC treatments

  • Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable

  • Adolescent participants 鈮�16 and

Lead researcher

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