MK-8690 for Ulcerative Colitis

Recruiting at 6 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Prohibited medications

Disqualifiers: Crohn's disease, Fulminant colitis, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this protocol is to evaluate the efficacy of MK-8690 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that MK-8690 is superior to placebo with respect to the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

Inclusion Criteria

I have not responded, lost response, or cannot tolerate at least one required UC treatment.

I am taking the required study drugs and my condition is stable on them.

I have had ulcerative colitis for at least 3 months.

Exclusion Criteria

I do not have any active infections right now.

I have Crohn's disease, indeterminate colitis, or another type of colitis or enteritis.

My ulcerative colitis is only in my rectum.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive MK-8690 or placebo via subcutaneous injection for 12 weeks

12 weeks

Treatment Period 2

Participants who do not respond to treatment in Period 1 receive MK-8690 via subcutaneous injection for 12 weeks

12 weeks

Treatment Period 3

Participants who respond to treatment in either Period 1 or Period 2 receive additional MK-8690 via subcutaneous injection for up to approximately 42 weeks

42 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MK-8690

How Is the Trial Designed?

Group I: Period 3: MK-8690 Experimental Treatment 1 Intervention

Participants who respond to treatment in either Period 1 or Period 2 will receive additional MK-8690 via subcutaneous injection for up to approximately 42 weeks.

Group II: Period 2: MK-8690 Experimental Treatment 1 Intervention

Participants who do not respond to treatment in Period 1 (regardless of treatment assignment in Period 1) will receive MK-8690 via subcutaneous injection for 12 weeks.

Group III: Period 1: MK-8690 Experimental Treatment 1 Intervention

Participants will receive MK-8690 via subcutaneous injection for 12 weeks.

Group IV: Period 1: Placebo Placebo Group 1 Intervention

Participants will receive placebo via subcutaneous injection for 12 weeks.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University