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Birch pollen allergen extract

Phase 3

Hypersensitivity | Monoclonal antibody | Other |Catalent, Inc.|Last Updated: Nov 27, 2012

Development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Nov 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment574

FDA Designations

No designations recorded

Clinical trial landscape

Birch pollen allergen extract · 1 trial · 4 indications

Phase 3 1
NCT01731249Efficacy and Safety Study of a Sublingual Immunotherapy Solution to Treat Patients Suffering From Birch Pollen Allergic RhinoconjunctivitisHypersensitivity
COMPLETED574 Analytics
PHASE3COMPLETED
Efficacy and Safety Study of a Sublingual Immunotherapy Solution to Treat Patients Suffering From Birch Pollen Allergic Rhinoconjunctivitis
Hypersensitivity
NCT01731249574
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Study Endpoints

Primary Endpoints

Average Adjusted Symptom Score
Year 2 of treatment

Symptom score adjusted on patient's rescue medication usage

Secondary Endpoints

Average Rhinoconjunctivitis Total Symptom Score
Year 2 of treatment
Average Rescue Medication Score
Year 2 of treatment
Each of Six Individual Average Rhinoconjunctivitis Symptom Scores
Year 2 of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo sublingual solution
Birch pollen allergen extractEXPERIMENTALSublingual Solution of Birch pollen allergen extract 300IR once daily 5 months per year and during 2 years

Interventions

NameTypeDescription
PlaceboBIOLOGICAL10 actuations of placebo sublingual solution once daily 5 months a year and during 2 years
Birch pollen allergen extractBIOLOGICALSublingual solution of Birch pollen allergen extract 300IR (10 actuations) once daily 5 months per year and during 2 years
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the previous 2 pollen seasons requiring intake of symptomatic treatment. * Sensitization to birch pollen demonstrated by a positive Skin Prick Test to birch pollen with wheal diameter \> 3 mm and birch ...

Countries:CzechiaDenmarkEstoniaFinlandFranceGermanyLatviaLithuaniaPolandSlovakiaSweden
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