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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00133159
Recruitment Status : Completed
First Posted : August 23, 2005
Last Update Posted : June 17, 2010
Information provided by:
Allergy Therapeutics

August 22, 2005
August 23, 2005
June 17, 2010
September 2005
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immunological response to the three GrassMATAMPL treatment arms compared to placebo (grass specific)
Same as current
Complete list of historical versions of study NCT00133159 on Archive Site
  • 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)
Same as current
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Different Doses of Tyrosine Adsorbed Grass Pollen Allergoid With Monophosphoryl Lipid A (MPL) in Patients Sensitized to Grass Pollen
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.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Type I Hypersensitivity
Biological: Grass MATAMPL
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Allergy Therapeutics
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Study Chair: Karl Jürgen Fischer von Weikersthal-Drachenberg, MD Allergy Therapeutics
Allergy Therapeutics
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP