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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 May 2016
• Main ID: NCT02321709
• Date of registration: 05/12/2014
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients
• Scientific 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
• Date of first enrolment: November 2014
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02321709
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: SAR113244

Drug: placebo

Primary Outcome(s)

Change in physical examination, body weight, vital signs and laboratory parameters [Time Frame: Up to 16 weeks after inclusion]

Number of participants with adverse events and treatment-emergent adverse events [Time Frame: 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) [Time Frame: Up to 16 weeks after inclusion]

Secondary Outcome(s)

Assessment of pharmacokinetic parameter - time of maximum concentration (Tmax) [Time Frame: Up to D113 after inclusion]

Assessment of pharmacokinetic parameter - apparent total body clearance (CLss/F) [Time Frame: 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) [Time Frame: Up to D113 after inclusion]

Pharmacodynamic parameters: peripheral blood B and T cells subsets [Time Frame: Up to D85 after inclusion]

Assessment of pharmacokinetic parameter - absorption-dependent apparent volume of distribution at steady state (Vss/F) [Time Frame: Up to D113 after inclusion]

Number of participants with anti-SAR113244 antibody titers [Time Frame: Up to D226 after inclusion]

Assessment of pharmacokinetic parameter - lowest concentration of drug before the next dose (Ctrough) [Time Frame: Up to D113 after inclusion]

Assessment of pharmacokinetic parameter - area under curve 0-4 weeks (AUC0-4w) [Time Frame: Up to D113 after inclusion]

Pharmacodynamic parameter changes [Time Frame: Up to D113 after inclusion]

Assessment of pharmacokinetic parameter - maximum concentration (Cmax) [Time Frame: Up to D113 after inclusion]

Secondary ID(s)

TDR11407

2014-001690-13

U1111-1154-6184

Source(s) of Monetary Support

Please refer to primary and secondary sponsors