A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Systemic Lupus Erythematosus

Conditions

Systemic Lupus Erythematosus

Brief summary

Proportion of patients who achieve a response at Week 24, defined according to the BILAGBased Composite Lupus Assessment (BICLA) Response

Detailed description

Proportion of patients who achieve response according to the Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 24, Proportion of patients who achieve Lupus Low Disease Activity State (LLDAS) at Week 24., Time to flare, Proportion of patients achieving prednisone equivalent dose ≤ 5 mg/day by the Week 12 visit and maintained through Week 24 with no disease worsening, Proportion of patients who achieve a ≥ 50% improvement from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score (CLASI-50 response) at Week 24 compared with baseline, Proportion of patients who achieve ≥ 50% decrease in active joint count (Joint-50 response) at Week 24 compared with baseline, Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score at Week 24

Related papers

No related papers found yet.

Interventions

DRUGObexelimab

DRUGPlacebo sterile solution for SC injection

DRUGPREDNISOLONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of patients who achieve a response at Week 24, defined according to the BILAGBased Composite Lupus Assessment (BICLA) Response	—

Secondary

Measure	Time frame
Proportion of patients who achieve response according to the Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 24, Proportion of patients who achieve Lupus Low Disease Activity State (LLDAS) at Week 24., Time to flare, Proportion of patients achieving prednisone equivalent dose ≤ 5 mg/day by the Week 12 visit and maintained through Week 24 with no disease worsening, Proportion of patients who achieve a ≥ 50% improvement from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score (CLASI-50 response) at Week 24 compared with baseline, Proportion of patients who achieve ≥ 50% decrease in active joint count (Joint-50 response) at Week 24 compared with baseline, Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score at Week 24	—

Measure

Time frame

Proportion of patients who achieve response according to the Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Week 24, Proportion of patients who achieve Lupus Low Disease Activity State (LLDAS) at Week 24., Time to flare, Proportion of patients achieving prednisone equivalent dose ≤ 5 mg/day by the Week 12 visit and maintained through Week 24 with no disease worsening, Proportion of patients who achieve a ≥ 50% improvement from baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score (CLASI-50 response) at Week 24 compared with baseline, Proportion of patients who achieve ≥ 50% decrease in active joint count (Joint-50 response) at Week 24 compared with baseline, Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score at Week 24

—

Countries

Belgium, Bulgaria, Denmark, Germany, Greece, Italy, Poland, Portugal, Romania, Spain

Outcome results

None listed