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

Allergy Therapeutics

Status and phase

Completed

Phase 2

Conditions

Type I Hypersensitivity

Treatments

Biological: Grass MATAMPL

Study type

Interventional

Funder types

Industry

Identifiers

NCT00133159

GrassMATAMPL203

P2DP5005

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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