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 Patients
Primary Objective:
To assess the tolerability and safety of SAR113244 in male and female lupus patients after
every 4 (Q4) weeks repeated ascending subcutaneous doses of SAR113244.
Secondary Objectives:
To assess in male and female lupus patients:
- The pharmacokinetics of SAR113244.
- The pharmacodynamics of SAR113244 for the following disease-related 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
(SRI) (if applicable), Lupus-quality of life (QoL) and Functional Assessment of
Chronic Illness Therapy (FACIT)-Fatigue, anti-double stranded deoxyribonucleic
acid antibody (anti-dsDNA Ab) and anti-nuclear antibody levels (ANA) and plasma
complement levels (C3, C4), erythrocyte sedimentation (SED) rate and C-reactive
protein.
- Peripheral blood B and T cells subsets.
The total duration of screening to end of study per subject is 20 weeks with post-study observation on Day 226 for anti-drug antibody assessment (for patients with positive anti-drug antibody at end of study only). ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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