Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients
- Registration Number
- NCT02321709
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR113244 cohort 3 SAR113244 Two administrations of dosage 3 SAR113244 or placebo subcutaneous dose (Q4 weeks) SAR113244 cohort 1 SAR113244 Two administrations of dosage 1 SAR113244 or placebo subcutaneous dose (Q4 weeks) SAR113244 cohort 3 placebo Two administrations of dosage 3 SAR113244 or placebo subcutaneous dose (Q4 weeks) SAR113244 cohort 1 placebo Two administrations of dosage 1 SAR113244 or placebo subcutaneous dose (Q4 weeks) SAR113244 cohort 2 SAR113244 Two administrations of dosage 2 SAR113244 or placebo subcutaneous dose (Q4 weeks) SAR113244 cohort 2 placebo Two administrations of dosage 2 SAR113244 or placebo subcutaneous dose (Q4 weeks)
- Primary Outcome Measures
Name Time Method Number of participants with adverse events and treatment-emergent adverse events Up to 16 weeks after inclusion Change in physical examination, body weight, vital signs and laboratory parameters Up to 16 weeks after inclusion Safety and tolerability (erythema, swelling, degree of itching, and present pain intensity at injection site by measuring diameter and qualitative assessment) Up to 16 weeks after inclusion
- Secondary Outcome Measures
Name Time Method Pharmacodynamic parameter changes Up to D113 after inclusion Assessment of pharmacokinetic parameter - maximum concentration (Cmax) Up to D113 after inclusion Assessment of pharmacokinetic parameter - time of maximum concentration (Tmax) Up to D113 after inclusion Assessment of pharmacokinetic parameter - area under curve 0-4 weeks (AUC0-4w) Up to D113 after inclusion Assessment of pharmacokinetic parameter - time of the last point with quantifiable concentration (tlast) and terminal elimination half-life (t1/2z) Up to D113 after inclusion Assessment of pharmacokinetic parameter - lowest concentration of drug before the next dose (Ctrough) Up to D113 after inclusion Assessment of pharmacokinetic parameter - apparent total body clearance (CLss/F) Up to D113 after inclusion Assessment of pharmacokinetic parameter - absorption-dependent apparent volume of distribution at steady state (Vss/F) Up to D113 after inclusion Number of participants with anti-SAR113244 antibody titers Up to D226 after inclusion Pharmacodynamic parameters: peripheral blood B and T cells subsets Up to D85 after inclusion
Trial Locations
- Locations (1)
Investigational Site Number 276001
🇩🇪Berlin, Germany