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

NCT02321709 | Completed Phase 1 DMC

• 3 other identifiers: TDR114072014-001690-13U1111-1154-6184
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (3)

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

  Up to 16 weeks after inclusion

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

  Up to 16 weeks after inclusion

• 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

Secondary Outcomes (10)

• Assessment of pharmacokinetic parameter - maximum concentration (Cmax)

  Up to D113 after inclusion

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

  Up to D113 after inclusion

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

  Up to D113 after inclusion

• 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

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

  Up to D113 after inclusion

Study Arms (3)

SAR113244 cohort 1

EXPERIMENTAL

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

Drug: SAR113244; Drug: placebo

SAR113244 cohort 2

EXPERIMENTAL

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

Drug: SAR113244; Drug: placebo

SAR113244 cohort 3

EXPERIMENTAL

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

Drug: SAR113244; Drug: placebo

Interventions

SAR113244 DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

SAR113244 cohort 1; SAR113244 cohort 2; SAR113244 cohort 3

placebo DRUG

Pharmaceutical form:solution for injection Route of administration: subcutaneous

SAR113244 cohort 1; SAR113244 cohort 2; SAR113244 cohort 3

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 systemic lupus erythematosus (SLE) by American College Rheumatology criteria.
• Autoantibody-posititve.
• On active and stable SLE disease.

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, 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 276001

Berlin, 10117, Germany

Location

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: December 22, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 2, 2016

Record last verified: 2016-04

Locations

DE (1)