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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: SAR113244; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02321709

2014-001690-13 (EudraCT Number)

U1111-1154-6184 (Other Identifier)

TDR11407

Details and patient eligibility

About

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.

Full 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).

Enrollment: 21 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 3 patient groups

SAR113244 cohort 1

Experimental group

Description:

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

Treatment:

Drug: SAR113244

Drug: placebo

SAR113244 cohort 2

Experimental group

Description:

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

Treatment:

Drug: SAR113244

Drug: placebo

SAR113244 cohort 3

Experimental group

Description:

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

Treatment:

Drug: SAR113244

Drug: placebo