NCT04996797

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

A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy With PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Tulisokibart	Administered by IV infusion
DEVICE	Companion Diagnostic (CDx) Testing	PRA023 CDx Genotyping Assay
OTHER	Placebo	Placebo administered by IV infusion

Timeline

• Start date: 2021-07-14
• Primary completion: 2023-06-06
• Completion: 2025-07-14
• First posted: 2021-08-09
• Last updated: 2025-08-06
• Results posted: 2024-06-27

Locations

88 sites across 12 countries: United States, Australia, Belgium, Canada, Czechia, France, Georgia, Hungary, Israel, Italy, Poland, United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study