Systemic Lupus Erythematosus
Conditions
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).
Interventions
DRUGSAR113244
Pharmaceutical form:solution for injection Route of administration: subcutaneous
DRUGplacebo
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Pharmacodynamic parameter changes | Up to D113 after inclusion |
| Assessment of pharmacokinetic parameter - apparent total body clearance (CLss/F) | Up to D113 after inclusion |
| Assessment of pharmacokinetic parameter - absorption-dependent apparent volume of distribution at steady state (Vss/F) | Up to D113 after inclusion |
| Number of participants with anti-SAR113244 antibody titers | Up to D226 after inclusion |
| Assessment of pharmacokinetic parameter - lowest concentration of drug before the next dose (Ctrough) | Up to D113 after inclusion |
| Pharmacodynamic parameters: peripheral blood B and T cells subsets | Up to D85 after inclusion |
| Assessment of pharmacokinetic parameter - maximum concentration (Cmax) | Up to D113 after inclusion |
Countries
Germany
Outcome results
None listed