A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus

Conditions

Systemic Lupus Erythematosus

Brief summary

Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28, Percentage of Participants Experiencing Adverse Events (AEs), Percentage of Participants Discontinuing Study Treatment Due to an AE

Detailed description

Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment Response (BICLA) at Week 28, Percentage of Participants Achieving SRI-4 Response at Week 52, Percentage of Participants Achieving BICLA at Week 52, Percentage of Participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50 Response at Week 28, Percentage of Participants with a CLASI-50 Response at Week 52, 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, Change From Baseline of Corticosteroid Dose at Week 52, Cumulative Oral Corticosteroid Use Between Week 0 to Week 28, Cumulative Oral Corticosteroid Use Between Week 0 to Week 52, Percentage of Participants Who Achieve Low Level of Disease Activity (LLDAS) at Week 28, Percentage of Participants Who Achieve LLDAS at Week 52

Related papers

No related papers found yet.

Interventions

DRUGMK-6194

DRUGPlacebo for MK-6194

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28, Percentage of Participants Experiencing Adverse Events (AEs), Percentage of Participants Discontinuing Study Treatment Due to an AE	—

Secondary

Measure	Time frame
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment Response (BICLA) at Week 28, Percentage of Participants Achieving SRI-4 Response at Week 52, Percentage of Participants Achieving BICLA at Week 52, Percentage of Participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50 Response at Week 28, Percentage of Participants with a CLASI-50 Response at Week 52, 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, Change From Baseline of Corticosteroid Dose at Week 52, Cumulative Oral Corticosteroid Use Between Week 0 to Week 28, Cumulative Oral Corticosteroid Use Between Week 0 to Week 52, Percentage of Participants Who Achieve Low Level of Disease Activity (LLDAS) at Week 28, Percentage of Participants Who Achieve LLDAS at Week 52	—

Measure

Time frame

Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment Response (BICLA) at Week 28, Percentage of Participants Achieving SRI-4 Response at Week 52, Percentage of Participants Achieving BICLA at Week 52, Percentage of Participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50 Response at Week 28, Percentage of Participants with a CLASI-50 Response at Week 52, 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, Change From Baseline of Corticosteroid Dose at Week 52, Cumulative Oral Corticosteroid Use Between Week 0 to Week 28, Cumulative Oral Corticosteroid Use Between Week 0 to Week 52, Percentage of Participants Who Achieve Low Level of Disease Activity (LLDAS) at Week 28, Percentage of Participants Who Achieve LLDAS at Week 52

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Countries

France, Italy, Poland, Spain

Outcome results

None listed