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

Primary Purpose

Type I Hypersensitivity

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Tree MATA MPL - Therapeutic Regimen
Tree MATA MPL - Intermediate dose
Tree MATA MPL - Low dose
Placebo
Sponsored by
Allergy Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type I Hypersensitivity focused on measuring Allergy, Specific Immunotherapy, Allergy Vaccination, Allergenicity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allied Research International Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Therapeutic Regimen

Intermediate dose

Low dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Tolerability of individual subcutaneous doses
Tolerability of the cumulative subcutaneous doses
safety laboratory evaluation - clinical chemistry
safety laboratory evaluation - hematology
safety laboratory evaluation - urinalysis
Vital signs
Physical examinations
Abnormal physical examination findings were summarized by clinical significance(CS or NCS) using frequencies and percentages of patients for each body system and overall
12-Lead ECGs
QRS duration, PR interval, QT interval, and QTc
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)

Full Information

First Posted
July 1, 2005
Last Updated
February 5, 2021
Sponsor
Allergy Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00118612
Brief Title
Different Doses of Tyrosine Adsorbed Tree Pollen Allergoid With Monophosphoryl Lipid A (MPL) in Patients Sensitized to Tree Pollen
Official Title
A DoubleBlind Phase 2b Study to Evaluate Safety & Efficacy of Different Doses of Tyrosine Adsorbed Birch+Hazel+Alder Pollen Allergoid With MPL® in Patients Sensitized to Birch, Hazel, Alder Pollen
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 7, 2005 (Actual)
Primary Completion Date
September 15, 2005 (Actual)
Study Completion Date
September 15, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergy Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes

5. Study Description

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.
Detailed Description
Tree MATAMPL (tyrosine adsorbed tree pollen allergoid with monophosphoryl lipid A (MPL®)) has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross-reacting tree pollens that cause rhinitis and/or conjunctivitis with or without mild to moderate asthma. This was a phase IIb, double-blind, placebo-controlled study to assess the tolerability and immunogenicity of different doses of Tree MATA MPL in volunteers allergic to birch, hazel and alder pollen. Sixty eight (68) volunteers were randomly assigned to one of three active treatments or placebo to receive up to 4 subcutaneous injections of either increasing doses of Tree MATAMPL or Placebo over 7 day (+1 day) interval. The duration of the study from screening (Visit 1) to end of study (Visit 6, Post-Treatment Visit) was approximately 50 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type I Hypersensitivity
Keywords
Allergy, Specific Immunotherapy, Allergy Vaccination, Allergenicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Regimen
Arm Type
Experimental
Arm Title
Intermediate dose
Arm Type
Experimental
Arm Title
Low dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Tree MATA MPL - Therapeutic Regimen
Intervention Description
600, 1600, 4000, 4000 SU/0.5 mL
Intervention Type
Biological
Intervention Name(s)
Tree MATA MPL - Intermediate dose
Intervention Description
300, 600, 1600, 1600 SU/0.5 mL
Intervention Type
Biological
Intervention Name(s)
Tree MATA MPL - Low dose
Intervention Description
300, 300, 300, 300 SU/0.5 mL
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
L-tyrosine 2% w/v , 4 injections
Primary Outcome Measure Information:
Title
Immunological response to the three Tree MATA MPL treatment arms compared to placebo (birch specific)
Description
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.
Time Frame
Up to two approximately 2 months
Secondary Outcome Measure Information:
Title
Tolerability of individual subcutaneous doses
Time Frame
Up to two approximately 2 months
Title
Tolerability of the cumulative subcutaneous doses
Time Frame
Up to two approximately 2 months
Title
safety laboratory evaluation - clinical chemistry
Time Frame
Up to two approximately 2 months
Title
safety laboratory evaluation - hematology
Time Frame
Up to two approximately 2 months
Title
safety laboratory evaluation - urinalysis
Time Frame
Up to two approximately 2 months
Title
Vital signs
Time Frame
Up to two approximately 2 months
Title
Physical examinations
Description
Abnormal physical examination findings were summarized by clinical significance(CS or NCS) using frequencies and percentages of patients for each body system and overall
Time Frame
Up to two approximately 2 months
Title
12-Lead ECGs
Description
QRS duration, PR interval, QT interval, and QTc
Time Frame
Up to two approximately 2 months
Title
number of adverse events
Time Frame
Approximately 2 months
Title
number of adverse reactions
Time Frame
Up to two approximately 2 months
Title
immunological response to the three Tree MATA MPL treatment arms compared to placebo (alder and hazel specific)
Time Frame
Up to two approximately 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepen Patel, MD
Organizational Affiliation
Allied Research International Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allied Research International Inc.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1N2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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