Induction of Immunogenicity With Different Doses of TreeMATA in Subjects Allergic to Tree Pollen

Completed · Phase 2

Conditions studied: Type I Hypersensitivity

In brief

Tree MATA (modified pollen allergen tyrosine adsorbate) has been developed to provide pre-seasonal specific immunotherapy for patients with hypersensitivity to tree (birch, alder, and hazel) pollen. Different doses of Tree MATA will be administered and immunological changes following this treatment will be assessed.

Key facts

Study ID

NCT00113750

Run by

Allergy Therapeutics

People needed

70

Starts

2005-07-01

Expected to finish

2005-12-01

Last updated by the study team

2010-06-17

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Females of childbearing potential may enter the study if they have a negative urine pregnancy test and they have been practicing adequate contraception for 3 months prior to the study and continue to do so during the study
• History of at least 1 season of moderate to severe seasonal rhinoconjunctivitis without bronchial asthma due to an IgE mediated allergy to pollen from trees
• Positive skin prick test to birch, hazel and alder pollen allergen extract
• Positive skin prick test to positive histamine control
• Negative skin prick test to negative control
• Specific IgE for birch with class >= 2
• Moderate/severe allergy symptoms in the past tree season
• Spirometry at Screening demonstrates FEV1 >= 80% predicted and FEV1/FVC >= 70%.

You may not qualify if…

• History or presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence or any other skin conditions which might interfere with the interpretation of skin prick test results
• Visual inspection of the forearms indicates potential problems with the conduct or interpretation of the screening skin prick tests
• History of bronchial asthma, COPD, or other chronic condition of the lower respiratory tract
• History or presence of diabetes, cancer or any clinically significant cardiac, metabolic, renal, hepatic, gastrointestinal, dermatologic, venereal, hematologic, neurologic or psychiatric diseases or disorders
• Any clinically significant abnormal laboratory value at Visit 1
• Clinically relevant sensitivity to any common perennial allergen: house dust mites, molds, or epithelia. Subjects may be enrolled in the study if they test positive, but have no current symptoms to perennial allergens
• Clinically relevant sensitivity to summer/autumn flowering plants and grasses: Grass pollen mix, rye, plantain, orache, nettle, mugwort, bermuda grass, and ragweed. Subjects may be enrolled in the study if they test positive, but have no current symptoms to these summer/autumn allergens.
• History of auto-immune diseases or rheumatoid diseases
• Subject not allowed to receive adrenalin
• Subject has disorder of tyrosine metabolism
• Subject with diseases interfering with the immune response and have received medication, which could influence the results of this study
• Subject has acute or chronic infection
• History of anaphylaxis
• History of angioedema
• History of hypersensitivity to the excipients of the study medication
• History of immunotherapy with tree allergen extracts
• Current therapy with ß-blockers
• Currently receiving anti-allergy medication or other medications with antihistaminic activity
• Subject has a positive screening test to drugs of abuse at Visit 1
• Subject received investigational medication in a clinical research trial within the last 3 months
• Subject cannot communicate reliably with the Investigator or who are not likely to cooperate with the requirements of the study
• Subject is pregnant or lactating
• Use of prohibited medications or inadequate washout periods prior to screening

Where it is running

• Southern California Research — Mission Viejo, California, United States
• San Jose Clinical Research, Inc. — San Jose, California, United States
• Rx Research — Woodstock, Georgia, United States
• Iowa Clinical Research Corporation — Iowa City, Iowa, United States
• The Medical Center at Teaneck — Teaneck, New Jersey, United States
• Clinical Research Institute of Southern Oregon, PC — Medford, Oregon, United States
• Asthma and Allergy Research Associates — Upland, Pennsylvania, United States
• Bellingham Asthma, Allergy & Immunology Clinic — Bellingham, Washington, United States
• A.S.T.H.M.A., Inc. — Seattle, Washington, United States
• Pulmonary Consultants — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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