PRA023 for Ulcerative Colitis

(ARTEMIS-UC Trial)

Recruiting in Palo Alto (17 mi)

+86 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

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

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called PRA023 to help people with severe Ulcerative Colitis. The goal is to see if it can reduce inflammation and heal the digestive tract. Participants will be monitored for safety and effectiveness over several months.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for people with moderate to severe Ulcerative Colitis who haven't responded well to, or can't tolerate, certain UC treatments like steroids or immunosuppressants. Participants must have a confirmed diagnosis and be able to follow the study's procedures. Those with Crohn's disease, at high risk per investigator's opinion, or unable/unwilling to use effective contraception are excluded.

Inclusion Criteria

I have been diagnosed with ulcerative colitis.

I have not responded well or am intolerant to certain standard treatments.

My ulcerative colitis is moderate to severe.

Exclusion Criteria

I need or will soon need a surgery for a colostomy or ileostomy.

I currently have severe colon issues, including inflammation or surgery.

Subjects in the opinion of the investigator are at an unacceptable risk for participation in the study

Treatment Details

Interventions

• PRA023 (Monoclonal Antibodies)

Trial Overview The trial is testing PRA023 in two ways: directly through IV administration and by assessing its safety and effectiveness in those who test positive on companion diagnostic tests. After an initial 12-week period, participants can choose to continue treatment for another 38 weeks.

Participant Groups

Group I: Cohort 2 Tulisokibart Experimental Treatment 2 Interventions

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.

Group II: Cohort 1 Tulisokibart Experimental Treatment 1 Intervention

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.

Group III: Cohort 2 Placebo Placebo Group 2 Interventions

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.

Group IV: Cohort 1 Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

6

Recruited

600+

Prometheus Biosciences, Inc.

Lead Sponsor

Trials

6

Recruited

600+