- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00133159
Different Doses of Tyrosine Adsorbed Grass Pollen Allergoid With Monophosphoryl Lipid A (MPL) in Patients Sensitized to Grass Pollen
May 17, 2021 updated by: Allergy Therapeutics
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
68
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
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Mississauga, Ontario, Canada, L4W 1N2
- Allied Research International Inc.
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Mississauga, Ontario, Canada, L5B 1N1
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Ottawa, Ontario, Canada, K1Y 4G2
- Ottawa Allergy Research Corporation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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immunological response to the three GrassMATAMPL treatment arms compared to placebo (grass specific)
|
Secondary Outcome Measures
Outcome Measure |
---|
number of adverse events
|
number of adverse reactions
|
tolerability of different subcutaneous doses
|
tolerability of the cumulative subcutaneous doses
|
clinical chemistry and hematology
|
immunological response to the three GrassMATAMPL treatment arms compared to placebo (rye specific)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Kemi Oluwayi, MD, Allergy Therapeutics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 12, 2005
Primary Completion (ACTUAL)
November 8, 2005
Study Completion (ACTUAL)
November 8, 2005
Study Registration Dates
First Submitted
August 22, 2005
First Submitted That Met QC Criteria
August 22, 2005
First Posted (ESTIMATE)
August 23, 2005
Study Record Updates
Last Update Posted (ACTUAL)
May 18, 2021
Last Update Submitted That Met QC Criteria
May 17, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GrassMATAMPL203
- P2DP5005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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