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

This study has been completed.
Sponsor:
Information provided by:
Allergy Therapeutics
ClinicalTrials.gov Identifier:
NCT00133159
First received: August 22, 2005
Last updated: June 16, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Type I Hypersensitivity
Biological: Grass MATAMPL
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Allergy Therapeutics:

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)

Estimated Enrollment: 68
Study Start Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133159

Locations
Canada, Ontario
Allied Research International Inc.
Mississauga, Ontario, Canada, L4W 1N2
Mississauga, Ontario, Canada, L5B 1N1
Ottawa Allergy Research Corporation
Ottawa, Ontario, Canada, K1Y 4G2
Sponsors and Collaborators
Allergy Therapeutics
Investigators
Study Chair: Karl Jürgen Fischer von Weikersthal-Drachenberg, MD Allergy Therapeutics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00133159     History of Changes
Other Study ID Numbers: GrassMATAMPL203, P2DP5005
Study First Received: August 22, 2005
Last Updated: June 16, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Allergy Therapeutics:
Allergy
Specific Immunotherapy

Additional relevant MeSH terms:
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Monophosphoryl lipid A
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014