Systemic Lupus Erythematosus Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Study Of Safety, Tolerability, And Pharmacokinetics Of Repeated Ascending Subcutaneous Doses Of SAR113244 And Pharmacodynamics Of Single Dose Of SAR113244 In Male And Female Lupus Patient
Primary Objective:
Assess in systemic lupus erythematosus (SLE) patients the effect of SAR113244 on B-cell
subsets compared to placebo.
Secondary Objectives:
Assess in male and female lupus patients after SC single dose of SAR113244 the tolerability
and safety of SAR113244.
Assess in male and female lupus patients:
- The pharmacokinetics of SAR113244.
- The pharmacodynamics of SAR113244 for the following disease parameters:
- Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus
Erythematosus Disease Activity Index (SELENA-SLEDAI) score, British Isles Lupus
Assessment Group (BILAG) score (if applicable), BILAG-Based Composite Lupus
Assessment (BICLA) (if applicable), systemic lupus erythematosus responder index
(if applicable), Lupus-quality of life and Functional Assessment of Chronic
Illness Therapy-Fatigue, anti-double stranded deoxyribonucleic acid antibody and
anti-nuclear antibody levels and plasma complement levels (C3, C4), erythrocyte
sedimentation rate and C-reactive protein.
- Peripheral blood B and T cell subsets.
The total duration of screening to end of study per subject is 16 weeks with post-study observation on Day 198 for anti-drug antibody assessment (for patients with positive anti-drug antibody at end of study only). ;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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