Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients
Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
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.