A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

Conditions

• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

16 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• IV Tulisokibart — DRUG
  Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered intravenously
• IV Placebo — DRUG
  Placebo matching IV tulisokibart
• SC Tulisokibart — DRUG
  Humanized monoclonal antibody that binds human tumor necrosis factor-like cytokine 1A (TL1A), administered subcutaneously
• SC Placebo — DRUG
  Placebo matching SC tulisokibart

Study Details

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.

Key Dates

Start date

Oct 25, 2023

Status verified

Mar 2026

Primary completion

Aug 1, 2026

Completion

Aug 1, 2029

Study Design

Enrollment

1,020 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Study 1: High Dose Induction, High Dose Maintenance
  Participants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.
• Experimental: Study 1: High Dose Induction, Low Dose Maintenance
  Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
• Experimental: Study 1: Low Dose Induction, Low Dose Maintenance
  Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
• Placebo Comparator: Study 1: Placebo
  Participants receive IV placebo, followed by an SC placebo regimen.
• Experimental: Study 1: High Dose Extension
  Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
• Experimental: Study 1: Low Dose Extension
  Participants receive a low dose SC tulisokibart and placebo regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
• Experimental: Study 2: High Dose Induction
  Participants receive high dose IV tulisokibart.
• Experimental: Study 2: Low Dose Induction
  Participants receive low dose IV tulisokibart.
• Placebo Comparator: Study 2: Placebo
  Participants receive IV placebo.
• Experimental: Study 2: High Dose Extension
  Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
• Experimental: Study 2: Low Dose Extension
  Participants receive a low dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.

Primary Outcome Measure

Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12 [ Time Frame: Week 12 ]

Locations (76)

Find similar trials in Dothan, AL

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