Clinical trial NCT00133159: Different Doses of Tyrosine Adsorbed Grass Pollen Allergoid With Monophosphoryl Lipid A (MPL) in Patients Sensitized to Grass Pollen
Official title: A Double-Blind Phase IIb Study to Evaluate the Safety and Efficacy of Different Doses of Tyrosine Adsorbed Grass/Rye Pollen Allergoid With MPL in Patients Sensitized to Grass and Rye Pollen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type I Hypersensitivity
Keywords: Allergy
Specific Immunotherapy
Lead sponsor: Allergy Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-08-23
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. GrassMATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to grass pollen (hay fever). The purpose of this double-blind Phase IIb study is to assess the tolerability and immunogenicity of different doses of GrassMATAMPL in volunteers allergic to grasses and rye pollen.


Eligibility criteria: Inclusion Criteria:

* positive skin prick test for grass and rye allergen
* Specific IgE for grass and rye as documented by radioallergosorbent or equivalent test with class \>= 2
* History of at least 1 season of moderate to severe seasonal rhinoconjunctivitis due to an IgE - mediated allergy to pollen from grass and rye
* Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile. Females of childbearing potential have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using an acceptable birth control method.
* Spirometry at Screening demonstrates FEV1 \>= 80% predicted and FEV1/FVC \>= 70%

Exclusion Criteria:

* Acute or subacute atopic dermatitis and/or urticaria factitia and/or urticaria due to physical or chemical influence and/or chronic dermatitis
* Patient has moderate to severe asthma
* Visual inspection of the forearms indicates potential problems with the conduct or interpretation of the skin prick test; both forearms must be available for testing
* History or presence of diabetes, cancer or any clinically significant cardiac, metabolic renal, hematologic diseases or disorders
* Recent clinically significant history (within 2 years) of hepatic gastrointestinal, dermatologic, venereal, neurologic or psychiatric diseases or disorders
* Any clinically significant (as determined by the investigator) abnormal laboratory value
* Perennial allergens: clinically relevant sensitivity against house dust mites, molds, and epithelia
* Patient has clinically relevant sensitivity against the following summer/autumn season flowering plants: plantain, orache, nettle, mugwort, Bermuda grass, or ragweed.
* Secondary alteration at the affected organ
* History of autoimmune diseases and/or rheumatoid diseases
* Patient is taking b-blockers
* Patient who is not allowed to receive adrenalin
* Patients in whom tyrosine metabolism is disturbed
* Presence of a disease with a pathogenesis interfering with the immune response and patient has received medication which could influence the results of this study
* Documented evidence of acute or significant chronic infection
* History of anaphylaxis
* Documented history of angioedema
* Hypersensitivity to excipients in the study medications
* Previous or current immunotherapy with comparable grass/rye allergen extracts
* Currently using anti-allergy medication and other drugs with antihistaminic activity
* Patients currently participating in a clinical trial or who have been exposed to study medication within the last 30 days
* Patient is pregnant or planning pregnancy and/or lactating
* Patient has received treatment with preparation containing MPL® during the past 12 months
* Any systemic disorder that could interfere with the evaluation of the study medication(s)
* Clinical history of drug or alcohol abuse that would interfere with the patient's participation in the study

Primary outcomes:
measure: immunological response to the three GrassMATAMPL treatment arms compared to placebo (grass specific)
Secondary outcomes:
measure: tolerability of different subcutaneous doses
measure: tolerability of the cumulative subcutaneous doses
measure: clinical chemistry and hematology
measure: number of adverse events
measure: number of adverse reactions
measure: immunological response to the three GrassMATAMPL treatment arms compared to placebo (rye specific)
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Allied Research International Inc.
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Allergy Research Corporation
state: Ontario
Study officials:
affiliation: Allergy Therapeutics
name: Kemi Oluwayi, MD
role: STUDY_CHAIR
References: