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

COMPLETEDPHASE2

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

NCT04996797•Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Confirmed diagnosis of ulcerative colitis (UC)
•Has moderately to severely active UC as defined by 3-component Modified Mayo score
•Must have corticosteroid dependence or have had no response, insufficient response, loss of response, and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (anti-TNF), anti-integrin, anti-interleukin 12/23 (anti-IL12/23), Janus kinase (JAK) inhibitor, Sphingosine 1-phosphate receptor (S1PR) modulator.

Exclusion Criteria

•Has diagnosis of Crohn's disease or indeterminate colitis
•Has current evidence of fulminant colitis, toxic megacolon, bowel perforation, total proctocoloectomy or partial colectomy
•Has current or impending need for colostomy or ileostomy
•Has had surgical bowel resection within 3 months before screening
•Has past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed

Locations (88)

Prometheus Biosciences Selected Center

Mobile, Alabama, United States

Prometheus Biosciences Selected Site

Phoenix, Arizona, United States

Prometheus Biosciences Selected Site

Sun City, Arizona, United States

Prometheus Biosciences Selected Site

Los Angeles, California, United States

Prometheus Biosciences Selected Site

Los Angeles, California, United States

Prometheus Biosciences Selected Site

San Diego, California, United States

Prometheus Biosciences Selected Site

Bristol, Connecticut, United States

Prometheus Biosciences Selected Site

Atlanta, Georgia, United States

Prometheus Biosciences Selected Site

Arlington Heights, Illinois, United States

Prometheus Biosciences Selected Site

Glenview, Illinois, United States

Key Dates

Start Date

July 14, 2021

Primary Completion Date

June 6, 2023

Completion Date

July 14, 2025

Last Updated

August 6, 2025

Enrollment

178

ACTUAL participants

Conditions

Ulcerative Colitis

Interventions

Tulisokibart

DRUG

Companion Diagnostic (CDx) Testing

DEVICE

Placebo

OTHER

Sponsors

Lead Sponsor

Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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