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

• Status: Withdrawn
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

Inclusion criteria:

• Male or female patients, between 18 and 75 years of age, inclusive.

• Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.

• Autoantibody-positive.

• On active and stable SLE disease.

• B cell subsets expressed as percentage of total B cells above normal.

Exclusion criteria:

• Pregnant and nursing.

• Have received treatment with investigational drugs in the 4 months prior to the screening or 5 half-lives of the drug, which ever is longer.

• Have received intravenous or oral cyclophosphamide within 180 days of Day 0.

• Severe active lupus nephritis or chronic renal insufficiency.

• Active or chronic, severe neuropsychiatric lupus.

• Acute, recent (within 4 weeks of screening), chronic or frequently recurring infection(s), except minor infection.

• Have current drug or alcohol abuse or dependence.

• Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.