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

This study has been completed.
Sponsor:
Information provided by:
Allergy Therapeutics
ClinicalTrials.gov Identifier:
NCT00118612
First received: July 1, 2005
Last updated: June 16, 2010
Last verified: June 2010

July 1, 2005
June 16, 2010
July 2005
Not Provided
immunological response to the three Tree MATA MPL treatment arms compared to placebo (birch specific)
Same as current
Complete list of historical versions of study NCT00118612 on ClinicalTrials.gov 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 Tree MATA MPL treatment arms compared to placebo (alder and hazel specific)
Same as current
Not Provided
Not Provided
 
Different Doses of Tyrosine Adsorbed Tree Pollen Allergoid With Monophosphoryl Lipid A (MPL) in Patients Sensitized to Tree Pollen
A Double-Blind Phase IIb Study to Evaluate the Safety and Efficacy of Different Doses of Tyrosine Adsorbed Birch + Hazel + Alder Pollen Allergoid With MPL® in Patients Sensitized to Birch, Hazel, Alder 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. Tree MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to tree pollen (hay fever).

The purpose of this double-blind Phase IIb study is to assess the tolerability and immunogenicity of different doses of Tree MATA MPL in volunteers allergic to birch, hazel and alder pollen.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Type I Hypersensitivity
Biological: Tree MATA MPL
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
Not Provided
Not Provided

Inclusion Criteria:

  • Patients must have a positive skin prick test for birch and hazel and alder allergen.
  • Positive skin prick test to positive histamine control
  • Negative skin prick test to negative control
  • Specific IgE for birch 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 birch, hazel, and alder
  • Patients must score on the disease severity questionnaire as moderate or severe.
  • Males or non-pregnant, non-lactating females
  • Patients who are normally active and otherwise judged to be in good health
  • Patients must be willing and able to attend required study visits.
  • Patients must be able to follow instructions.
  • Patients must be willing and able to give written informed consent and must provide this consent.

Exclusion Criteria:

  • Acute or subacute atopic dermatitis and/or urticaria factitia and/or urticaria due to physical or chemical influence and/or chronic dermatitis
  • 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, or hematologic diseases or disorders
  • Recent clinically significant history of hepatic, gastrointestinal, dermatologic, venereal, neurologic or psychiatric diseases or disorders
  • Any clinically significant abnormal laboratory value at Visit 1
  • Perennial allergens: clinically relevant sensitivity to house dust mites, molds, and epithelia
  • Patient has clinically relevant sensitivity to the following summer/autumn season flowering plants: plantain, orache, nettle, mugwort, Parietaria judaica, Bermuda grass, or ragweed.
  • Secondary alteration at the affected organ
  • History of autoimmune diseases and/or rheumatoid diseases
  • Patient is taking ß-blockers for any indication including eye drops
  • 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
  • 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 tree 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
  • Patients who cannot communicate reliably with the Investigator or who are not likely to cooperate with the requirements of the study
  • Patient is pregnant or planning pregnancy and/or lactating
  • Patient has received treatment with preparation containing MPL during the past 12 months
  • Concurrent use of any prohibited medication(s), as listed in the study protocol, or inadequate washout of any medication
  • Any systemic disorder that could interfere with the evaluation of the study medication(s)
  • Clinical history of drug or alcohol abuse, at the Investigator's discretion, that would interfere with the patient's participation in the study
  • Study site staff or immediate relatives of study site staff or other individuals who would have access to the clinical study protocol
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00118612
TreeMATAMPL203, P2DP05003
Not Provided
Not Provided
Allergy Therapeutics
Not Provided
Principal Investigator: Deepen Patel, MD Allied Research International Inc.
Allergy Therapeutics
June 2010

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