MK-6194 for Lupus

Recruiting in Grand Blanc (>99 mi)

+142 other locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme LLC

Must be taking: Immunosuppressants, Dapsone, Antimalarials, Corticosteroids

Must not be taking: NSAIDs, Anti-infectives

Disqualifiers: Heart failure, Pulmonary disease, Organ transplant, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

270 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to be on at least one background therapy for lupus, such as an immunosuppressant, dapsone, antimalarial, or oral corticosteroids. However, you cannot be taking more than one immunosuppressant or more than one oral NSAID at a time.

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of MK-6194 in adult participants with Systemic Lupus Erythematosus. The primary hypothesis is that at least 1 of the MK-6194 arms is superior to placebo in the primary endpoint of percentage of participants with systemic lupus erythematosus responder index (SRI-4) response at Week 28.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

Adults with Systemic Lupus Erythematosus (SLE) for at least 6 months, currently on treatment like immunosuppressants or steroids, and have certain SLE symptoms such as a lupus rash or joint pain. They must also test positive for specific antibodies related to SLE.

Inclusion Criteria

My lupus activity score is high, indicating active disease.

I have tested positive for specific autoimmune antibodies.

I was diagnosed with lupus more than 6 months ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous MK-6194 or placebo for up to 28 weeks

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Extension

Participants may continue receiving MK-6194 in an open-label extension phase

24 weeks

Treatment Details

Interventions

• MK-6194

Trial Overview The trial is testing the effectiveness of MK-6194 compared to a placebo in improving SLE symptoms. Success is measured by the number of participants showing improvement on the SRI-4 scale at Week 28.

Participant Groups

Group I: Extension: Dose 2 Experimental Treatment 2 Interventions

Participants receive SC MK-6194 regimen 2. Participants from the arms "Base Study: Dose 2" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm.

Group II: Extension: Dose 1 Experimental Treatment 2 Interventions

Participants receive SC MK-6194 dose regimen 1. Participants from the arms "Base Study: Dose 1" or "Base Study: Placebo" may be enrolled in this arm after completing participation in their original arm.

Group III: Base Study: Dose 2 Experimental Treatment 1 Intervention

Participants receive SC MK-6194 dose regimen 2.

Group IV: Base Study: Dose 1 Experimental Treatment 1 Intervention

Participants receive subcutaneous (SC) MK-6194 dose regimen 1.

Group V: Base Study: Placebo Placebo Group 2 Interventions

Participants receive an SC placebo regimen.

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