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R926112

Phase 2

Rhinitis, Allergic, Seasonal | Small molecule | Other |Rigel Pharmaceuticals, Inc.|Last Updated: Nov 11, 2005

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment375
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT001150897 Day Study of Mast Cell Inhibitor, R926112, in Patients With Symptomatic Seasonal Allergic RhinitisPHASE2 COMPLETED 375Jul 1, 2005Sep 1, 2005Nov 11, 2005 -
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Study Endpoints
Primary Endpoints
Change in total nasal symptom score from baseline over time
Secondary Endpoints
Change in individual symptoms
Global therapeutic response
Quality of life score
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
R926112DRUG -
Beclomethasone dipropionateDRUG -
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subjects must sign a written informed consent form and assent (if applicable) for study participation. * Males and females, 12 years of age or older * Subjects must have a history consistent with seasonal allergic rhinitis (SAR) during the fall pollen season for at least the p...

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