MK-6194 for Ulcerative Colitis

Recruiting at 17 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme Corp.

Must not be taking: Recombinant IL-2, Modified IL-2

Disqualifiers: Severe colitis, Crohn's, Cardiac impairment, others

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 72 days

57 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called MK-6194 for people with active Ulcerative Colitis. It checks if the drug is safe, how it works in the body, and if it causes any immune reactions.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on advanced therapy, you must not have taken it within a certain period before starting the trial. It's best to discuss your specific medications with the trial team.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with active Ulcerative Colitis (UC) who haven't responded well to at least one conventional therapy and no more than two advanced therapies. They must have had a recent colonoscopy if over 50 or at risk of colorectal cancer, not be planning surgery soon, and agree to use effective contraception. Exclusions include severe colitis symptoms, certain infections or treatments, history of other significant diseases like heart or lung problems, prior UC surgery, organ transplants, malignancy within the past five years except some skin cancers.

Inclusion Criteria

Body mass index (BMI) 18 to 35 kg/m^2 inclusive and weight ≥ 50 kg

I do not have active or untreated tuberculosis.

My ulcerative colitis is active.

Exclusion Criteria

I have previously received IL-2 or similar therapy.

I do not have any serious illnesses besides ulcerative colitis.

History of abnormal pulmonary function tests

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of MK-6194 or placebo at specified intervals

Up to 72 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 13 weeks

Treatment Details

Interventions

• MK-6194
• MK-6194-matching placebo

Trial Overview The study tests MK-6194's safety and effectiveness in treating UC compared to a placebo. It will look into how the body processes the drug (pharmacokinetics), its impact on the disease (pharmacodynamics), and whether it causes any immune response (immunogenicity). Participants are randomly assigned to receive either MK-6194 or a matching placebo.

Participant Groups

Group I: MK-6194 Medium Dose- Interval 2 Experimental Treatment 1 Intervention

Participants received medium dose of MK-6194 at specified intervals

Group II: MK-6194 Low Dose - Interval 1 Experimental Treatment 1 Intervention

Participants received low dose of MK-6194 at specified intervals

Group III: MK-6194 High Dose- Interval 2 Experimental Treatment 1 Intervention

Participants received high dose of MK-6194 at specified intervals

Group IV: MK-6194 High Dose- Interval 1 Experimental Treatment 1 Intervention

Participants received high dose MK-6194 at specified intervals

Group V: Placebo Placebo Group 1 Intervention

Participants received MK- 6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

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

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

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

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