Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)

Conditions

• Systemic Lupus Erythematosus

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• MK-6194 — BIOLOGICAL
  SC Injection
• Placebo — BIOLOGICAL
  SC Injection

Study Details

The purpose of this study is to evaluate the efficacy and safety of MK-6194 in adult participants with systemic lupus erythematosus.

Key Dates

First listed

Dec 7, 2023

Start date

Dec 27, 2023

Status verified

Jul 2026

Primary completion

Jul 30, 2025

Completion

Jul 30, 2025

Study Design

Enrollment

149 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: MK-6194 3 mg Q2W
  Participants receive subcutaneous (SC) MK-6194 3 mg every 2 weeks (q2w).
• Experimental: MK-6194 3 mg Q4W
  Participants receive SC MK-6194 3 mg every 4 weeks (q4w).
• Placebo Comparator: Placebo
  Participants receive SC placebo q2w.
• Experimental: MK-6194 3 mg Q2W (Main Study) / MK-6194 3 mg Q2W (Extension Period)
  After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q2w in the main study, participants continue to receive SC MK-6194 3 mg q2w in the extension period.
• Experimental: MK-6194 3 mg Q4W (Main Study) / MK-6194 3 mg Q4W (Extension Period)
  After completing 52 weeks of treatment with SC MK-6194 administered 3 mg q4w in the main study, participants continue to receive SC MK-6194 3 mg q4w in the extension period.
• Experimental: Placebo (Main Study)/ MK-6194 3 mg Q2W (Extension Period)
  After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants are re-randomized to receive SC MK-6194 3 mg q2w in the extension period.
• Experimental: Placebo (Main Study)/ MK-6194 3 mg Q4W (Extension Period)
  After completing 52 weeks of treatment with SC placebo administered q2w in the main study, participants are re-randomized to receive SC MK-6194 3 mg q4w in the extension period.

Primary Outcome Measure

Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28 [ Time Frame: Week 28 ]

Locations (19)

Find similar trials in Covina, CA

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