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

Primary Purpose

Systemic Lupus Erythematosus

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

SAR113244

placebo

About this trial

This is an interventional basic science trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Investigational Site Number 276001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

SAR113244 cohort 1

SAR113244 cohort 2

SAR113244 cohort 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Number of participants with adverse events and treatment-emergent adverse events

Change in physical examination, body weight, vital signs and laboratory parameters

Safety and tolerability (erythema, swelling, degree of itching, and present pain intensity at injection site by measuring diameter and qualitative assessment)

Secondary Outcome Measures

Assessment of pharmacokinetic parameter - maximum concentration (Cmax)

Assessment of pharmacokinetic parameter - time of maximum concentration (Tmax)

Assessment of pharmacokinetic parameter - area under curve 0-4 weeks (AUC0-4w)

Assessment of pharmacokinetic parameter - time of the last point with quantifiable concentration (tlast) and terminal elimination half-life (t1/2z)

Assessment of pharmacokinetic parameter - lowest concentration of drug before the next dose (Ctrough)

Assessment of pharmacokinetic parameter - apparent total body clearance (CLss/F)

Assessment of pharmacokinetic parameter - absorption-dependent apparent volume of distribution at steady state (Vss/F)

Number of participants with anti-SAR113244 antibody titers

Pharmacodynamic parameter changes

Pharmacodynamic parameters: peripheral blood B and T cells subsets

Full Information

NCT ID

NCT02321709

First Posted

December 5, 2014

Last Updated

April 29, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02321709

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAR113244 cohort 1

Arm Type

Experimental

Arm Description

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

Arm Title

SAR113244 cohort 2

Arm Type

Experimental

Arm Description

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

Arm Title

SAR113244 cohort 3

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

SAR113244

Intervention Description

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Primary Outcome Measure Information:

Title

Number of participants with adverse events and treatment-emergent adverse events

Time Frame

Up to 16 weeks after inclusion

Title

Change in physical examination, body weight, vital signs and laboratory parameters

Time Frame

Up to 16 weeks after inclusion

Title

Safety and tolerability (erythema, swelling, degree of itching, and present pain intensity at injection site by measuring diameter and qualitative assessment)

Time Frame

Up to 16 weeks after inclusion

Secondary Outcome Measure Information:

Title

Assessment of pharmacokinetic parameter - maximum concentration (Cmax)

Time Frame

Up to D113 after inclusion

Title

Assessment of pharmacokinetic parameter - time of maximum concentration (Tmax)

Time Frame

Up to D113 after inclusion

Title

Assessment of pharmacokinetic parameter - area under curve 0-4 weeks (AUC0-4w)

Time Frame

Up to D113 after inclusion

Title

Assessment of pharmacokinetic parameter - time of the last point with quantifiable concentration (tlast) and terminal elimination half-life (t1/2z)

Time Frame

Up to D113 after inclusion

Title

Assessment of pharmacokinetic parameter - lowest concentration of drug before the next dose (Ctrough)

Time Frame

Up to D113 after inclusion

Title

Assessment of pharmacokinetic parameter - apparent total body clearance (CLss/F)

Time Frame

Up to D113 after inclusion

Title

Assessment of pharmacokinetic parameter - absorption-dependent apparent volume of distribution at steady state (Vss/F)

Time Frame

Up to D113 after inclusion

Title

Number of participants with anti-SAR113244 antibody titers

Time Frame

Up to D226 after inclusion

Title

Pharmacodynamic parameter changes

Time Frame

Up to D113 after inclusion

Title

Pharmacodynamic parameters: peripheral blood B and T cells subsets

Time Frame

Up to D85 after inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 276001

City

Berlin

ZIP/Postal Code

10117

Country

Germany

12. IPD Sharing Statement

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

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