Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients

Sanofi21 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Systemic Lupus Erythematosus

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion criteria: * Male or female patients, between 18 and 75 years of age, inclusive. * Clinical diagnosis of systemic lupus erythematosus (SLE) by American College Rheumatology criteria. * Autoantibody-posititve. * On active and stable SLE disease. 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, whichever 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 postitive 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.

Outcomes

Primary Outcomes

Number of participants with adverse events and treatment-emergent adverse events

Time frame: Up to 16 weeks after inclusion

Change in physical examination, body weight, vital signs and laboratory parameters

Time frame: 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)

Time frame: Up to 16 weeks after inclusion