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Allergen extract

Phase 1

Allergic Rhinitis | Monoclonal antibody | Other |Thermo Fisher Scientific Inc|Last Updated: Mar 11, 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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02301884Pilot Study of Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic RhinitisPHASE1 COMPLETED 12Nov 1, 2013Mar 1, 2015Mar 11, 20151 South Korea
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Study Endpoints
Primary Endpoints
RQLQ
Baseline and 4 months after the first injection

Rhinoconjunctivitis Quality of Life Questionnaire

Secondary Endpoints
SNOT-20
Baseline and 4 months after the first injection
Skin reactivity
Baseline and 4 months after the first injection
Serum total and allergen-specific IgE and IgG4 level
Baseline and 4 months after the first injection
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Allergen extractEXPERIMENTALCausal allergen such as D. farinae (30 AU/ml), D. pteronyssinus (30 AU/ml), cat hair (10 AU/ml), dog hair/dander (1:1/10 w/v), or combination of those. Allergen extract, HollisterStier, New Orleans, USA. Intralymphatic injection in volume of 0.1 ml, three times with 4-week interval. Concentration was increased, decreased, or unchanged at 2nd or 3rd injection according to local or systemic reaction after previous injection
Interventions
NameTypeDescription
Allergen extractBIOLOGICALCausal allergen extract such as D. farinae, D. pteronyssinus, cat hair, dog hair/dander, or combination of those
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Eligibility Criteria
Age Range19 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Allergic rhinitis to house dust mite (Df, Dp), cat or dog * More than 3mm reaction at skin prick test for Df, Dp, cat or dog or more than class 3 at serum specific IgE level (UNICAP or MAST) Exclusion Criteria: * Uncontrolled or severe asthma according to Global Initiative o...

Countries:South Korea
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Competitive Landscape -Allergic Rhinitis 4 trials