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Phleum pratense grass pollen allergen extract

Phase 3

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment107

FDA Designations

No designations recorded

Clinical trial landscape

Phleum pratense grass pollen allergen extract · 1 trial · 1 indication

Phase 3 1
NCT02245360Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic RhinoconjunctivitisSeasonal Allergic Rhinitis
COMPLETED107 Analytics
PHASE3COMPLETED
Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
Seasonal Allergic RhinitisUnlock trial analytics

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 to 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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Frequently asked questions about Phleum pratense grass pollen allergen extract

What is Phleum pratense grass pollen allergen extract used for?

Phleum pratense grass pollen allergen extract is used for seasonal allergic rhinitis, specifically grass pollen-induced allergic rhinoconjunctivitis. It is an investigational sublingual immunotherapy tablet being developed by Abbott Laboratories for the treatment of this condition.

Who makes Phleum pratense grass pollen allergen extract?

Abbott Laboratories (NYSE: ABT) is developing Phleum pratense grass pollen allergen extract. The drug is being studied as a sublingual immunotherapy tablet for seasonal allergic rhinitis caused by grass pollen.

What phase is Phleum pratense grass pollen allergen extract in?

Phleum pratense grass pollen allergen extract is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 3 trial has been completed to evaluate its immunology and safety.

What clinical trials is Phleum pratense grass pollen allergen extract in?

Phleum pratense grass pollen allergen extract has one completed Phase 3 trial, NCT02245360. This study evaluated the immunology and safety of 60-day treatment with SQ grass SLIT-tablet in 107 adult subjects with grass pollen-induced allergic rhinoconjunctivitis in Russia.

How does Phleum pratense grass pollen allergen extract work?

Phleum pratense grass pollen allergen extract is a sublingual immunotherapy that works by exposing the immune system to grass pollen allergens. This exposure is intended to induce immune tolerance and reduce allergic responses to grass pollen, thereby alleviating symptoms of seasonal allergic rhinitis.