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

NCT ID: NCT02321709

Last Updated: 2016-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-03-31

Brief Summary

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.

Detailed Description

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).

Conditions

Systemic Lupus Erythematosus

Study Design

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

Study Groups

SAR113244 cohort 1

Two administrations of dosage 1 SAR113244 or placebo subcutaneous dose (Q4 weeks)

Group Type: EXPERIMENTAL

SAR113244

Intervention Type: DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

placebo

Intervention Type: DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

SAR113244 cohort 2

Two administrations of dosage 2 SAR113244 or placebo subcutaneous dose (Q4 weeks)

Group Type: EXPERIMENTAL

SAR113244

Intervention Type: DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

placebo

Intervention Type: DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

SAR113244 cohort 3

Two administrations of dosage 3 SAR113244 or placebo subcutaneous dose (Q4 weeks)

Group Type: EXPERIMENTAL

SAR113244

Intervention Type: DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

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 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.

• 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

Locations

Investigational Site Number 276001

Berlin, , Germany

Countries

Germany

Other Identifiers

2014-001690-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1154-6184

Identifier Type: OTHER

Identifier Source: secondary_id

TDR11407

Identifier Type: -

Identifier Source: org_study_id