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

NCT02331810 | Withdrawn Phase 1 DMC

• 3 other identifiers: PDY140762014-001690-13U1111-1154-6184
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

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

  Up to Day 57 after inclusion

Secondary Outcomes (13)

• Assessment of pharmacokinetic parameter - maximum concentration (Cmax)

  Up to Day 198 after inclusion

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

  Up to D198 after inclusion

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

  Up to Day 198 after inclusion

• 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

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

  Up to Day 85 after inclusion

Study Arms (2)

SAR113244

EXPERIMENTAL

Single subcutaneous dose of SAR113244

Drug: SAR113244

Placebo

PLACEBO COMPARATOR

Single subcutaneous dose of placebo

Drug: placebo

Interventions

SAR113244 DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

SAR113244

placebo DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: January 6, 2015
• Study Start: April 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: June 3, 2016

Record last verified: 2016-06