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SAR156597

Phase 2

Systemic Sclerosis | Small molecule | Other |Sanofi|Last Updated: Mar 21, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment97
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02921971Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic SclerosisPHASE2 COMPLETED 97Dec 21, 2016Apr 1, 2019Mar 21, 202244 United States, Argentina +11
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Study Endpoints
Primary Endpoints
Change From Baseline in Modified Rodnan Skin Score to Week 24
Baseline, Week 24

mRSS, an accepted clinical measure of the skin thickness (fibrosis). Investigator physicians or qualified medical personnel assessed the thickening of skin in 17 skin sites including fingers, hands, forearms, arms, feet, legs and thighs, face, chest and abdomen. Each skin site was rated on a 0-3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness and 3 = severe thickness. Total mRSS ranged from 0 (no thickening) to 51 (severe thickening in all 17 areas), where higher score indicated more severity of skin thickening/worst outcome.

Secondary Endpoints
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 24
Baseline, Week 24
Change From Baseline in Mean Observed Forced Vital Capacity (FVC) Level to Week 24
Baseline, Week 24
Change From Baseline in Mean Observed Diffusing Lung Capacity for Carbon Monoxide (DLco) to Week 24
Baseline, Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo (for SAR156597), single subcutaneous (SC) injection once in a week (QW) up to Week 24.
SAR156597EXPERIMENTALSAR156597 200 milligram (mg), single SC injection QW up to Week 24.
Interventions
NameTypeDescription
SAR156597DRUGPharmaceutical form: Solution Route of administration: Subcutaneous
PlaceboDRUGPharmaceutical form: Solution Route of administration: Subcutaneous
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion criteria : * Systemic Sclerosis (SSc) according to the American College of Rheumatology/The European League against Rheumatism (ACR/EULAR) 2013 criteria. * Diffused cutaneous form of SSc according to Leroy's criteria. * Able and willing to sign the written informed consent form with compr...

Countries:United StatesArgentinaBelgiumEstoniaFranceGermanyItalyMexicoPolandRomaniaRussiaUkraineUnited Kingdom
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