NCT02331810

Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female Patients

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	SAR113244	Pharmaceutical form:solution for injection Route of administration: subcutaneous
DRUG	placebo	Pharmaceutical form:solution for injection Route of administration: subcutaneous

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2015-01-06
• Last updated: 2016-06-03