NCT00118612

Different Doses of Tyrosine Adsorbed Tree Pollen Allergoid With Monophosphoryl Lipid A (MPL) in Patients Sensitized to Tree Pollen

A DoubleBlind Phase 2b Study to Evaluate Safety & Efficacy of Different Doses of Tyrosine Adsorbed Birch+Hazel+Alder Pollen Allergoid With MPL® in Patients Sensitized to Birch, Hazel, Alder Pollen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Allergy Therapeutics · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities of an allergen extract to an allergic patient, is a curative approach which directly treats the underlying allergic disease. Tree MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to tree pollen (hay fever). The purpose of this double-blind Phase IIb study is to assess the tolerability and immunogenicity of different doses of Tree MATA MPL in volunteers allergic to birch, hazel and alder pollen.

Detailed description

Tree MATAMPL (tyrosine adsorbed tree pollen allergoid with monophosphoryl lipid A (MPL®)) has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross-reacting tree pollens that cause rhinitis and/or conjunctivitis with or without mild to moderate asthma. This was a phase IIb, double-blind, placebo-controlled study to assess the tolerability and immunogenicity of different doses of Tree MATA MPL in volunteers allergic to birch, hazel and alder pollen. Sixty eight (68) volunteers were randomly assigned to one of three active treatments or placebo to receive up to 4 subcutaneous injections of either increasing doses of Tree MATAMPL or Placebo over 7 day (+1 day) interval. The duration of the study from screening (Visit 1) to end of study (Visit 6, Post-Treatment Visit) was approximately 50 days.

Conditions

• Type I Hypersensitivity

Interventions

Type	Name	Description
BIOLOGICAL	Tree MATA MPL - Therapeutic Regimen	600, 1600, 4000, 4000 SU/0.5 mL
BIOLOGICAL	Tree MATA MPL - Intermediate dose	300, 600, 1600, 1600 SU/0.5 mL
BIOLOGICAL	Tree MATA MPL - Low dose	300, 300, 300, 300 SU/0.5 mL
BIOLOGICAL	Placebo	L-tyrosine 2% w/v , 4 injections

Timeline

• Start date: 2005-07-07
• Primary completion: 2005-09-15
• Completion: 2005-09-15
• First posted: 2005-07-12
• Last updated: 2021-02-09

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study