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SAR113244

Phase 1

Systemic Lupus Erythematosus | Small molecule | Immunology |Sanofi|Last Updated: May 2, 2016

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

SAR113244 · 1 trial · 1 indication

Phase 1 1
NCT02321709Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female PatientsSystemic Lupus Erythematosus
COMPLETED21 Analytics
PHASE1COMPLETED
Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients
Systemic Lupus ErythematosusUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
SAR113244 cohort 1EXPERIMENTALTwo administrations of dosage 1 SAR113244 or placebo subcutaneous dose (Q4 weeks)
SAR113244 cohort 2EXPERIMENTALTwo administrations of dosage 2 SAR113244 or placebo subcutaneous dose (Q4 weeks)
SAR113244 cohort 3EXPERIMENTALTwo administrations of dosage 3 SAR113244 or placebo subcutaneous dose (Q4 weeks)

Interventions

NameTypeDescription
SAR113244DRUGPharmaceutical form:solution for injection Route of administration: subcutaneous
placeboDRUGPharmaceutical form:solution for injection Route of administration: subcutaneous
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

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....

Countries:Germany
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Frequently asked questions about SAR113244

What is SAR113244 used for?

SAR113244 is an investigational small molecule being developed for the treatment of Systemic Lupus Erythematosus (SLE). It is currently in Phase 1 clinical development and has been studied in a completed multiple ascending dose trial in lupus patients.

Who makes SAR113244?

SAR113244 is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker SNY. The drug is an investigational small molecule in Phase 1 clinical development for Systemic Lupus Erythematosus.

What phase is SAR113244 in?

SAR113244 is in Phase 1 clinical development. It has completed one Phase 1 trial, and no active trials are currently listed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is SAR113244 in?

SAR113244 has been studied in one completed Phase 1 clinical trial, identified as NCT02321709. This was a multiple ascending dose study to assess the safety profile of SAR113244 versus placebo in male and female lupus patients, conducted in Germany with 21 participants.

Is SAR113244 FDA approved?

SAR113244 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Systemic Lupus Erythematosus. The only trial conducted, NCT02321709, has been completed, but the drug remains in early-stage clinical testing.