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

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.

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).

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.