MK-6194 for Lupus
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous MK-6194 or placebo for up to 28 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants may continue receiving MK-6194 in an open-label extension phase
Treatment Details
Interventions
- MK-6194
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
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