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Monoclonal Antibodies

MK-6194 for Lupus

Phase 2

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score of ≥6 and clinical hybrid SLEDAI score of ≥4.

Has + antinuclear antibody (+ANA) (titer ≥1:80) or positive anti-double-strand deoxyribonucleic acid (dsDNA) antibody or positive anti-Sm antibody, or positive anti-SSA/Ro antibody.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Summary

This trial is testing a medication called MK-6194 to see if it is effective and safe for adults with Systemic Lupus Erythematosus. The main goal is to find out if

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects may include reactions at injection sites, gastrointestinal issues, increased risk of infections due to immune system suppression, and potential liver or kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lupus activity score is high, indicating active disease.

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I have tested positive for specific autoimmune antibodies.

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I have an active lupus rash or more than 2 swollen/tender joints in my hands.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28

Percentage of Participants Discontinuing Study Treatment Due to an AE

Percentage of Participants Experiencing Adverse Events (AEs)

Secondary study objectives

Change From Baseline of 28 Joint Count at Week 28

Change From Baseline of 28 Joint Count at Week 52

Change From Baseline of Corticosteroid Dose at Week 28

+10 more

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Extension: Dose 2Experimental Treatment2 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 1Experimental Treatment2 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 2Experimental Treatment1 Intervention

Participants receive SC MK-6194 dose regimen 2.

Group IV: Base Study: Dose 1Experimental Treatment1 Intervention

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

Group V: Base Study: PlaceboPlacebo Group2 Interventions

Participants receive an SC placebo regimen.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995