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Phleum pratense grass pollen allergen extract

Phase 3

Seasonal Allergic Rhinitis | Small molecule | Other |Abbott Laboratories|Last Updated: Jan 11, 2016

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment107
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02245360Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic RhinoconjunctivitisPHASE3 COMPLETED 107Oct 1, 2014Mar 1, 2015Jan 11, 201615 Russia
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Study Endpoints
Primary Endpoints
The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum
baseline versus end of treatment (approx. 60 days)

measurement of IgG4 in serum

Secondary Endpoints
Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment
baseline versus end of treatment (approx. 60 days)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Grass tablet 75,000 SQ-TEXPERIMENTALGrass tablet 75,000 Standardized Quality units Tablet (SQ-T)
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
Phleum pratense grass pollen allergen extractDRUGAllergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days
placeboDRUGplacebo tablet given once daily over 60 days
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * clinical history consistent with grass pollen-induced allergic rhinoconjunctivitis. * Use of symptomatic treatment of grass pollen-induced allergic rhinoconjunctivitis. * Positive skin prick test response (wheal diameter ≥3 mm) to Phleum pratense. * If asthma, daily use of Inh...

Countries:Russia
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