Multiple Ascending Dose Study To Assess The Safety Profile 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 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321709
• Other study ID #: TDR11407
• Secondary ID: 2014-001690-13U1
• Status: Completed
• Phase: Phase 1
• First received: December 5, 2014
• Last updated: April 29, 2016
• Start date: November 2014
• Est. completion date: March 2016

Study information

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

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• 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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety 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
Germany	Investigational Site Number 276001	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events and treatment-emergent adverse events		Up to 16 weeks after inclusion	Yes
Primary	Change in physical examination, body weight, vital signs and laboratory parameters		Up to 16 weeks after inclusion	Yes
Primary	Safety and tolerability (erythema, swelling, degree of itching, and present pain intensity at injection site by measuring diameter and qualitative assessment)		Up to 16 weeks after inclusion	Yes
Secondary	Assessment of pharmacokinetic parameter - maximum concentration (Cmax)		Up to D113 after inclusion	No
Secondary	Assessment of pharmacokinetic parameter - time of maximum concentration (Tmax)		Up to D113 after inclusion	No
Secondary	Assessment of pharmacokinetic parameter - area under curve 0-4 weeks (AUC0-4w)		Up to D113 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 D113 after inclusion	Yes
Secondary	Assessment of pharmacokinetic parameter - lowest concentration of drug before the next dose (Ctrough)		Up to D113 after inclusion	No
Secondary	Assessment of pharmacokinetic parameter - apparent total body clearance (CLss/F)		Up to D113 after inclusion	No
Secondary	Assessment of pharmacokinetic parameter - absorption-dependent apparent volume of distribution at steady state (Vss/F)		Up to D113 after inclusion	No
Secondary	Number of participants with anti-SAR113244 antibody titers		Up to D226 after inclusion	No
Secondary	Pharmacodynamic parameter changes		Up to D113 after inclusion	No
Secondary	Pharmacodynamic parameters: peripheral blood B and T cells subsets		Up to D85 after inclusion	No