Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female Patients
- Registration Number
- NCT02331810
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR113244 SAR113244 Single subcutaneous dose of SAR113244 Placebo placebo Single subcutaneous dose of placebo
- Primary Outcome Measures
Name Time Method Percentage decrease in B cell subsets (expressed as percentages of total B-cells) from baseline Up to Day 57 after inclusion
- Secondary Outcome Measures
Name Time Method Assessment of pharmacokinetic parameter - time of maximum concentration (Tmax) Up to D198 after inclusion Number of participants with anti-SAR113244 antibody titers Up to Day 198 after inclusion Assessment of pharmacokinetic parameter-apparent oral clearance (CL/F) Up to Day 85 after inclusion Assessment of pharmacokinetic parameter- absorption-dependent apparent volume of distribution at steady state (Vss/F) Up to Day 85 after inclusion Assessment of pharmacodynamics - clinical and/or lupus-related scores Up to Day 85 after inclusion Assessment of pharmacodynamics - blood/urine parameters Up to Day 85 after inclusion Assessment of pharmacokinetic parameter - maximum concentration (Cmax) Up to Day 198 after inclusion Assessment of pharmacokinetic parameter - area under curve from zero to infinity (AUCinf) Up to Day 198 after inclusion Assessment of pharmacokinetic parameter - time of the last point with quantifiable concentration (tlast) and terminal elimination half-life (t1/2z) Up to Day 85 after inclusion Number of participants with abnormalities and changes in laboratory parameters Up to Day 85 after inclusion Number of participants with adverse events and treatment-emergent adverse events, including those that deviated from baseline values of hematology, biochemistry, coagulation and urine Up to Day 198 after inclusion Number of participants with injection site reactions Up to Day 85 after inclusion Pharmacodynamic parameters: peripheral blood B and T cells subsets Up to Day 85 after inclusion