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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02331810
• Other study ID #: PDY14076
• Secondary ID: 2014-001690-13U1
• Status: Withdrawn
• Phase: Phase 1
• First received: December 5, 2014
• Last updated: June 2, 2016
• Start date: April 2016
• Est. completion date: May 2017

Study information

• Verified date: June 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• SAR113244
Pharmaceutical form:solution for injection Route of administration: subcutaneous
• placebo
Pharmaceutical form:solution for injection Route of administration: subcutaneous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage decrease in B cell subsets (expressed as percentages of total B-cells) from baseline		Up to Day 57 after inclusion	No
Secondary	Assessment of pharmacokinetic parameter - maximum concentration (Cmax)		Up to Day 198 after inclusion	No
Secondary	Assessment of pharmacokinetic parameter - time of maximum concentration (Tmax)		Up to D198 after inclusion	No
Secondary	Assessment of pharmacokinetic parameter - area under curve from zero to infinity (AUCinf)		Up to Day 198 after inclusion	No
Secondary	Assessment of pharmacokinetic parameter - time of the last point with quantifiable concentration (tlast) and terminal elimination half-life (t1/2z)		Up to Day 85 after inclusion	No
Secondary	Assessment of pharmacokinetic parameter-apparent oral clearance (CL/F)		Up to Day 85 after inclusion	No
Secondary	Assessment of pharmacokinetic parameter- absorption-dependent apparent volume of distribution at steady state (Vss/F)		Up to Day 85 after inclusion	No
Secondary	Number of participants with anti-SAR113244 antibody titers		Up to Day 198 after inclusion	Yes
Secondary	Number of participants with adverse events and treatment-emergent adverse events, including those that deviated from baseline values of hematology, biochemistry, coagulation and urine		Up to Day 198 after inclusion	Yes
Secondary	Number of participants with injection site reactions		Up to Day 85 after inclusion	Yes
Secondary	Number of participants with abnormalities and changes in laboratory parameters		Up to Day 85 after inclusion	Yes
Secondary	Assessment of pharmacodynamics - clinical and/or lupus-related scores		Up to Day 85 after inclusion	No
Secondary	Assessment of pharmacodynamics - blood/urine parameters		Up to Day 85 after inclusion	No
Secondary	Pharmacodynamic parameters: peripheral blood B and T cells subsets		Up to Day 85 after inclusion	No