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

Primary Purpose

Type I Hypersensitivity

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Grass MATAMPL
Sponsored by
Allergy Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type I Hypersensitivity focused on measuring Allergy, Specific Immunotherapy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Allied Research International Inc.
  • Ottawa Allergy Research Corporation

Outcomes

Primary Outcome Measures

immunological response to the three GrassMATAMPL treatment arms compared to placebo (grass specific)

Secondary Outcome Measures

tolerability of different subcutaneous doses
tolerability of the cumulative subcutaneous doses
clinical chemistry and hematology
number of adverse events
number of adverse reactions
immunological response to the three GrassMATAMPL treatment arms compared to placebo (rye specific)

Full Information

First Posted
August 22, 2005
Last Updated
May 17, 2021
Sponsor
Allergy Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00133159
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 12, 2005 (Actual)
Primary Completion Date
November 8, 2005 (Actual)
Study Completion Date
November 8, 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Allergy Therapeutics

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type I Hypersensitivity
Keywords
Allergy, Specific Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
68 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Grass MATAMPL
Primary Outcome Measure Information:
Title
immunological response to the three GrassMATAMPL treatment arms compared to placebo (grass specific)
Secondary Outcome Measure Information:
Title
tolerability of different subcutaneous doses
Title
tolerability of the cumulative subcutaneous doses
Title
clinical chemistry and hematology
Title
number of adverse events
Title
number of adverse reactions
Title
immunological response to the three GrassMATAMPL treatment arms compared to placebo (rye specific)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kemi Oluwayi, MD
Organizational Affiliation
Allergy Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
Allied Research International Inc.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1N2
Country
Canada
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 1N1
Country
Canada
Facility Name
Ottawa Allergy Research Corporation
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4G2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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