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SSR150106

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Sanofi|Last Updated: Aug 8, 2017

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 Enrollment79
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00545454Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid ArthritisPHASE2 COMPLETED 79Oct 1, 2007Jun 1, 2008Aug 8, 20177 Bulgaria, Croatia +5
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Study Endpoints
Primary Endpoints
Change from baseline in mean C-Reactive Protein level
end of the 4-week double-blind treatment period
Secondary Endpoints
C-Reactive Protein, Serum Amyloid A and Cytokine Interleukin-6 levels
at all time points measured
Improvement responder rates based on the American College of Rheumatology criteria
at all time points measured
Pain relief (change from baseline)
until day 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SSR150106 QDEXPERIMENTAL90 micro grams oral solution once daily (QD)
SSR150106 OEQDEXPERIMENTAL90 micro grams oral solution once every other day (OEQD)
PlaceboPLACEBO_COMPARATORoral solution QD or OEQD
Interventions
NameTypeDescription
SSR150106DRUG -
PlacebosDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Either treatment-naïve patients, or those who have discontinued their Rheumatoid Arthritis-directed medication due to intolerability or insufficient efficacy * At least 9 out of 68 tender joints; 6 out of 66 swollen joints; morning stiffness 45 min * C-Reactive Protein \>=1.8 ...

Countries:BulgariaCroatiaCzechiaRomaniaRussiaSlovakiaUkraine
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