Back to results

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

Primary Purpose

Systemic Lupus Erythematosus

Status

Withdrawn

Phase

Phase 1

Locations

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 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SAR113244

Placebo

Arm Description

Single subcutaneous dose of SAR113244

Single subcutaneous dose of placebo

Outcomes

Primary Outcome Measures

Percentage decrease in B cell subsets (expressed as percentages of total B-cells) from baseline

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 from zero to infinity (AUCinf)

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

Assessment of pharmacokinetic parameter-apparent oral clearance (CL/F)

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

Number of participants with anti-SAR113244 antibody titers

Number of participants with adverse events and treatment-emergent adverse events, including those that deviated from baseline values of hematology, biochemistry, coagulation and urine

Number of participants with injection site reactions

Number of participants with abnormalities and changes in laboratory parameters

Assessment of pharmacodynamics - clinical and/or lupus-related scores

Assessment of pharmacodynamics - blood/urine parameters

Pharmacodynamic parameters: peripheral blood B and T cells subsets

Full Information

NCT ID

NCT02331810

First Posted

December 5, 2014

Last Updated

June 2, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02331810

Brief Title

Pharmacodynamics Assessment Study After Single Subcutaneous Dose 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 Patient

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Withdrawn

Study Start Date

April 2016 (undefined)

Primary Completion Date

May 2017 (Anticipated)

Study Completion Date

May 2017 (Anticipated)

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: 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.

Detailed 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).

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

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAR113244

Arm Type

Experimental

Arm Description

Single subcutaneous dose of SAR113244

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Single subcutaneous dose of placebo

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

Percentage decrease in B cell subsets (expressed as percentages of total B-cells) from baseline

Time Frame

Up to Day 57 after inclusion

Secondary Outcome Measure Information:

Title

Assessment of pharmacokinetic parameter - maximum concentration (Cmax)

Time Frame

Up to Day 198 after inclusion

Title

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

Time Frame

Up to D198 after inclusion

Title

Assessment of pharmacokinetic parameter - area under curve from zero to infinity (AUCinf)

Time Frame

Up to Day 198 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 Day 85 after inclusion

Title

Assessment of pharmacokinetic parameter-apparent oral clearance (CL/F)

Time Frame

Up to Day 85 after inclusion

Title

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

Time Frame

Up to Day 85 after inclusion

Title

Number of participants with anti-SAR113244 antibody titers

Time Frame

Up to Day 198 after inclusion

Title

Number of participants with adverse events and treatment-emergent adverse events, including those that deviated from baseline values of hematology, biochemistry, coagulation and urine

Time Frame

Up to Day 198 after inclusion

Title

Number of participants with injection site reactions

Time Frame

Up to Day 85 after inclusion

Title

Number of participants with abnormalities and changes in laboratory parameters

Time Frame

Up to Day 85 after inclusion

Title

Assessment of pharmacodynamics - clinical and/or lupus-related scores

Time Frame

Up to Day 85 after inclusion

Title

Assessment of pharmacodynamics - blood/urine parameters

Time Frame

Up to Day 85 after inclusion

Title

Pharmacodynamic parameters: peripheral blood B and T cells subsets

Time Frame

Up to Day 85 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs