Induction of Immunogenicity With Different Doses of TreeMATA in Subjects Allergic to Tree Pollen
A Multicenter, Single-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Induction of Immunogenicity With Different Doses of Tree MATA in Subjects Allergic to Tree Pollen
1 other identifier
interventional
70
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2005
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2005
CompletedFirst Posted
Study publicly available on registry
June 13, 2005
CompletedStudy Start
First participant enrolled
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedJune 17, 2010
June 1, 2010
June 10, 2005
June 16, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-injection antibody response to birch
Secondary Outcomes (3)
Adverse Events (AEs)
Clinical laboratory evaluations
Vital signs
Interventions
Eligibility Criteria
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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Southern California Research
Mission Viejo, California, 92691, United States
San Jose Clinical Research, Inc.
San Jose, California, 95128, United States
Rx Research
Woodstock, Georgia, 30188, United States
Iowa Clinical Research Corporation
Iowa City, Iowa, 52240, United States
The Medical Center at Teaneck
Teaneck, New Jersey, 07666, United States
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504, United States
Asthma and Allergy Research Associates
Upland, Pennsylvania, 19013, United States
Bellingham Asthma, Allergy & Immunology Clinic
Bellingham, Washington, 98225, United States
A.S.T.H.M.A., Inc.
Seattle, Washington, 98105, United States
Pulmonary Consultants
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Karl Jürgen Fischer von Weikersthal-Drachenberg, MD
Allergy Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 10, 2005
First Posted
June 13, 2005
Study Start
July 1, 2005
Study Completion
December 1, 2005
Last Updated
June 17, 2010
Record last verified: 2010-06