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

NCT00118612 | Completed Phase 2 FDA Drug

• 2 other identifiers: TreeMATAMPL203P2DP05003
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Type I Hypersensitivity

Keywords

Allergy; Specific Immunotherapy; Allergy Vaccination; Allergenicity

Outcome Measures

Primary Outcomes (1)

• Immunological response to the three Tree MATA MPL treatment arms compared to placebo (birch specific)

  Efficacy was assessed based on the immunological differences between the three Tree MATA MPL treatment arms compared to placebo with respect to immunoglobulins (specific IgG, specific IgG1, specific IgG4, and specific IgE) for birch, alder, and hazel.

  Up to two approximately 2 months

Secondary Outcomes (11)

• Tolerability of individual subcutaneous doses

  Up to two approximately 2 months

• Tolerability of the cumulative subcutaneous doses

  Up to two approximately 2 months

• safety laboratory evaluation - clinical chemistry

  Up to two approximately 2 months

• safety laboratory evaluation - hematology

  Up to two approximately 2 months

• safety laboratory evaluation - urinalysis

  Up to two approximately 2 months

Study Arms (4)

Therapeutic Regimen

EXPERIMENTAL

Biological: Tree MATA MPL - Therapeutic Regimen

Intermediate dose

EXPERIMENTAL

Biological: Tree MATA MPL - Intermediate dose

Low dose

EXPERIMENTAL

Biological: Tree MATA MPL - Low dose

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

Tree MATA MPL - Therapeutic Regimen BIOLOGICAL

600, 1600, 4000, 4000 SU/0.5 mL

Therapeutic Regimen

Tree MATA MPL - Intermediate dose BIOLOGICAL

300, 600, 1600, 1600 SU/0.5 mL

Intermediate dose

Tree MATA MPL - Low dose BIOLOGICAL

300, 300, 300, 300 SU/0.5 mL

Low dose

Placebo BIOLOGICAL

L-tyrosine 2% w/v , 4 injections

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

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
• 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

Sponsors & Collaborators

• Allergy Therapeutics: lead

Study Sites (1)

Allied Research International Inc.

Mississauga, Ontario, L4W 1N2, Canada

Location

MeSH Terms

Conditions

Hypersensitivity, Immediate; Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Deepen Patel, MD

  Allied Research International Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2005
• First Posted: July 12, 2005
• Study Start: July 7, 2005
• Primary Completion: September 15, 2005
• Study Completion: September 15, 2005
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

CA (1)