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

NCT00133159 | Completed Phase 2

• 2 other identifiers: GrassMATAMPL203P2DP5005
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 3

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.

Conditions

Type I Hypersensitivity

Keywords

Allergy; Specific Immunotherapy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

• tolerability of different subcutaneous doses

• tolerability of the cumulative subcutaneous doses

• clinical chemistry and hematology

• number of adverse events

• number of adverse reactions

Interventions

Grass MATAMPL BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergy Therapeutics: lead

Study Sites (3)

Allied Research International Inc.

Mississauga, Ontario, L4W 1N2, Canada

Location

Unknown Facility

Mississauga, Ontario, L5B 1N1, Canada

Location

Ottawa Allergy Research Corporation

Ottawa, Ontario, K1Y 4G2, Canada

Location

MeSH Terms

Conditions

Hypersensitivity, Immediate; Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Kemi Oluwayi, MD

  Allergy Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 22, 2005
• First Posted: August 23, 2005
• Study Start: September 12, 2005
• Primary Completion: November 8, 2005
• Study Completion: November 8, 2005
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

CA (3)