A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)

Conditions

• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tulisokibart — DRUG
  Administered by IV infusion
• Companion Diagnostic (CDx) Testing — DEVICE
  PRA023 CDx Genotyping Assay
• Placebo — OTHER
  Placebo administered by IV infusion

Study Details

The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with moderately to severely active Ulcerative Colitis (UC). After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.

Key Dates

Start date

Jul 14, 2021

Status verified

Jul 2025

Primary completion

Jun 6, 2023

Completion

Jul 14, 2025

Study Design

Enrollment

178 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1 Tulisokibart
  Participants who are CDx+ and CDx- will receive tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0, and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
• Placebo Comparator: Cohort 1 Placebo
  Participants who are CDx+ and CDx- will receive placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
• Experimental: Cohort 2 Tulisokibart
  Participants who are CDx+ will receive tulisokibart administered by intravenous (IV) infusion at 1000 mg on Day 1, Week 0 and 500 mg on the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.
• Placebo Comparator: Cohort 2 Placebo
  Participants who are CDx+ will receive placebo administered by intravenous (IV) infusion on Day 1, Week 0 and the first day of Weeks 2, 6, and 10. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for up to 170 weeks.

Primary Outcome Measure

Percentage of Participants in Cohort 1 Achieving Clinical Remission [ Time Frame: Baseline and Week 12 ]

Locations (29)

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