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

NCT ID: NCT02331810

Last Updated: 2016-06-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

SAR113244

Single subcutaneous dose of SAR113244

Group Type: EXPERIMENTAL

SAR113244

Intervention Type: DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Placebo

Single subcutaneous dose of placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Interventions

SAR113244

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Intervention Type: DRUG

placebo

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

2014-001690-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1154-6184

Identifier Type: OTHER

Identifier Source: secondary_id

PDY14076

Identifier Type: -

Identifier Source: org_study_id