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JNJ-17166864

Phase 2

Allergic Rhinitis | Small molecule | Other |Johnson & Johnson|Last Updated: Apr 29, 2015

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 Enrollment74
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00604123A Study Evaluating Effects of Intranasal JNJ-17166864 on Symptoms of Allergic Rhinitis in AdultsPHASE2 COMPLETED 74Jan 1, 2008Feb 1, 2008Apr 29, 20151 United States
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Study Endpoints
Primary Endpoints
To determine the effect of twice daily dosing of intranasal JNJ-17166864, compared to placebo, on nasal symptoms of seasonal allergic rhinitis (nasal congestion, nasal itching, rhinorrhea, and sneezing)
allergic rhinitis symptom score during treatment phase (2 weeks)
Secondary Endpoints
To assess safety, tolerability, and pharmacokinetics
pharmacokinetics and biomarker assessment during treatment phase (2 weeks)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
JNJ-17166864EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
JNJ-17166864DRUGJNJ-17166864 0.5 mg per nostril twice daily for 2 weeks.
PlaceboDRUGPlacebo nasal spray twice daily for 2 weeks.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Have a clinical history of seasonal allergic rhinitis with onset and offset of nasal allergy symptoms during each of the past 2 mountain cedar allergy seasons * Have positive prick skin test reaction to mountain cedar allergen at screening or have a documented positive prick s...

Countries:United States
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Competitive Landscape -Allergic Rhinitis 4 trials