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ARRY-502, CRTh2 antagonist;

Phase 2

Asthma | Small molecule | Respiratory |Pfizer, Inc.|Last Updated: Oct 30, 2023

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_CONTROLLED
Total Trials1
Total Enrollment184
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01561690A Study of ARRY-502 in Patients With Persistent AsthmaPHASE2 COMPLETED 184Apr 2, 2012Jun 10, 2013Oct 30, 202343 United States
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Study Endpoints
Primary Endpoints
Assess the efficacy of the study drug (versus placebo) in terms of prebronchodilator forced expiratory volume in 1 second (FEV1).
6 weeks
Secondary Endpoints
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
6 weeks
Measure the exposure of study drug in terms of plasma concentrations.
6 weeks
Assess the effect of study drug on asthma control in terms of Asthma Control Questionnaire (ACQ) score, the number of symptom-free days and the number of weekly short-acting beta (ß) 2 agonist (SABA) metered dose inhaler (MDI) actuations.
6 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARRY-502EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ARRY-502, CRTh2 antagonist; oralDRUGmultiple dose, single schedule
Placebo; oralDRUGmatching placebo
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites43

Key Inclusion Criteria: * Documented history of bronchial asthma diagnosed at least 6 months prior to study start and prior to the age of 40 years. * Body mass index (BMI) of 18 to 35 inclusive. * An ACQ score of ≥ 1.5 at specified time points prior to first dose of study drug. * A best prebronchod...

Countries:United States
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