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Investigation of Safety+Efficacy of Different Doses of RagweedMATAMPL;Assessment of Residual Allergenicity Using Skin Prick Test

Primary Purpose

Type I Hypersensitivity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RagweedMATAMPL
Sponsored by
Allergy Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria: Patients must be male or female aged 18-50 years, inclusive. Patients must have a positive skin prick test for ragweed allergen (wheal that is ≥5 mm larger than the negative control). Positive skin prick test to positive histamine control with a wheal (longest) diameter ≥3 mm. Negative skin prick test to negative control (redness, but no wheal is acceptable). Specific IgE for ragweed 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 ragweed as derived from the allergic history. Patients must score in the disease severity questionnaire as moderate or severe. Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Females of childbearing potential have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using one of the following acceptable birth control methods: Intrauterine device in place for at least 90 days; Barrier method (condom or diaphragm) with spermicide; Stable hormonal contraceptive for at least 90 days prior to study and through study completion; Abstinence; Non-heterosexual lifestyle; Vasectomized partner for at least 90 days. Patients who are normally active and otherwise judged to be in good health on the basis of medical history, physical examination, and routine laboratory tests. 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 for this study. Consent must be obtained prior to initiation of any washout period. Spirometry at Screening demonstrates FEV1 ≥ 80% predicted and FEV1/FVC ≥70%, when applicable 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 (insulin dependent and non-dependent), 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 at Visit 1. Clinically relevant sensitivity against perennial allergens [house dust mites (Dermatophagoides pteronyssinus, Dermatophagoides farinae), molds (Cladosporium cladosporioides, Alternaria alternata, Penicillium chrysogenum, Aspergillus fumigatus), cat epithelia (Felis domesticus), dog epithelia (Canis familiaris) and horse epithelia (Equus caballus)], documented by a positive case history, prick test wheal size ≥3 mm in diameter larger than the negative control or radioallergosorbent test with class ≥2. Exceptions: The Investigator may judge the sensitivity as not clinically relevant. Clinically relevant sensitivity against seasonal allergens [mountain cedar, ash, birch, elm, maple, hickory, oak, cottonwood, bermuda grass and grass mix] documented by a positive case history, prick test wheal size ≥3 mm in diameter larger than the negative control or radioallergosorbent test with class ≥2. Exceptions: some or all of the listed allergens must not be tested if they are not common to the Investigator´s region or, if common to the region, no overlap exists between the allergen(s) season and the treatment and post treatment phase of the study. Furthermore, subjects will not be excluded if the Investigator may judge the sensitivity as not clinically relevant. Secondary alteration at the affected organ (i.e. emphysema, bronchiectasis). History of autoimmune diseases (e.g. of liver, kidney, thyroid, nervous system), 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, especially in the case of tyrosinemia and alkaptonuria. 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, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis. Documented history of angioedema. Hypersensitivity to excipients in the study medications. Previous or current immunotherapy with comparable ragweed 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),or inadequate washout of any medication. Any systemic disorder that could interfere with the evaluation of the study medication(s). Clinical history (within 2 years) of drug or alcohol abuse that would, in the opinion of the Investigator, interfere with the patient's participation in the study. Patient who has a positive urine drug screen (cocaine metabolites, cannabinoids, opiates, PCP, or amphetamine), or a positive alcohol saliva test. Study site staff or immediate relatives of study site staff or other individuals who would have access to the clinical study protocol.

Sites / Locations

  • Michigan Respiratory Health and Research Institute
  • Clinical Research Institute
  • Regional Allergy & Asthma Consultants
  • Lovelace Scientific Resources

Outcomes

Primary Outcome Measures

To assess immunological differences between three Ragweed MATA MPL treatment arms compared to placebo with respect to immunoglobulin levels (ragweed spec. IgG, IgG1, IgG4,IgE).

Secondary Outcome Measures

Residual allergenicity of modified Ragweed pollen in RagweedMATAMPL compared to unmodified native allergen using Skin Prick Test;
Tolerability of native, modified allergens and tyrosine adsorbents with and without MPL® using Skin Prick Test;
Tolerability of different subcutaneous doses;
Tolerability of the cumulative subcutaneous doses;
Clinical chemistry, hematology and urinalysis;
Number of Adverse Events (AEs);
Number of Adverse Reactions;

Full Information

First Posted
November 25, 2005
Last Updated
June 9, 2021
Sponsor
Allergy Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00258635
Brief Title
Investigation of Safety+Efficacy of Different Doses of RagweedMATAMPL;Assessment of Residual Allergenicity Using Skin Prick Test
Official Title
A Double-Blind Phase IIb Study to Evaluate the Safety and Efficacy of Different Doses of Tyrosine Adsorbed Ragweed Allergoid With MPL® With a Single-Blind Portion to Evaluate the Residual Allergenicity in Skin Test in Patients Sensitized to Ragweed Pollen.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
August 7, 2006 (Actual)
Study Completion Date
August 7, 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess the immunological differences between three RagweedMATAMPL treatment arms compared to placebo with respect to immunoglobulin levels. In addition, the study will assess the reduced allergenicity of modified Ragweed Pollen contained in RagweedMATAMPL compared to unmodified native allergen using skin prick testing.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
RagweedMATAMPL
Primary Outcome Measure Information:
Title
To assess immunological differences between three Ragweed MATA MPL treatment arms compared to placebo with respect to immunoglobulin levels (ragweed spec. IgG, IgG1, IgG4,IgE).
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Residual allergenicity of modified Ragweed pollen in RagweedMATAMPL compared to unmodified native allergen using Skin Prick Test;
Time Frame
20 minutes and 6 hours after skin prick test
Title
Tolerability of native, modified allergens and tyrosine adsorbents with and without MPL® using Skin Prick Test;
Time Frame
20 minutes and 6 hours after skin prick test
Title
Tolerability of different subcutaneous doses;
Time Frame
9 weeks
Title
Tolerability of the cumulative subcutaneous doses;
Time Frame
9 weeks
Title
Clinical chemistry, hematology and urinalysis;
Time Frame
9 weeks
Title
Number of Adverse Events (AEs);
Time Frame
9 weeks
Title
Number of Adverse Reactions;
Time Frame
9 weeks

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 be male or female aged 18-50 years, inclusive. Patients must have a positive skin prick test for ragweed allergen (wheal that is ≥5 mm larger than the negative control). Positive skin prick test to positive histamine control with a wheal (longest) diameter ≥3 mm. Negative skin prick test to negative control (redness, but no wheal is acceptable). Specific IgE for ragweed 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 ragweed as derived from the allergic history. Patients must score in the disease severity questionnaire as moderate or severe. Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Females of childbearing potential have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using one of the following acceptable birth control methods: Intrauterine device in place for at least 90 days; Barrier method (condom or diaphragm) with spermicide; Stable hormonal contraceptive for at least 90 days prior to study and through study completion; Abstinence; Non-heterosexual lifestyle; Vasectomized partner for at least 90 days. Patients who are normally active and otherwise judged to be in good health on the basis of medical history, physical examination, and routine laboratory tests. 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 for this study. Consent must be obtained prior to initiation of any washout period. Spirometry at Screening demonstrates FEV1 ≥ 80% predicted and FEV1/FVC ≥70%, when applicable 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 (insulin dependent and non-dependent), 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 at Visit 1. Clinically relevant sensitivity against perennial allergens [house dust mites (Dermatophagoides pteronyssinus, Dermatophagoides farinae), molds (Cladosporium cladosporioides, Alternaria alternata, Penicillium chrysogenum, Aspergillus fumigatus), cat epithelia (Felis domesticus), dog epithelia (Canis familiaris) and horse epithelia (Equus caballus)], documented by a positive case history, prick test wheal size ≥3 mm in diameter larger than the negative control or radioallergosorbent test with class ≥2. Exceptions: The Investigator may judge the sensitivity as not clinically relevant. Clinically relevant sensitivity against seasonal allergens [mountain cedar, ash, birch, elm, maple, hickory, oak, cottonwood, bermuda grass and grass mix] documented by a positive case history, prick test wheal size ≥3 mm in diameter larger than the negative control or radioallergosorbent test with class ≥2. Exceptions: some or all of the listed allergens must not be tested if they are not common to the Investigator´s region or, if common to the region, no overlap exists between the allergen(s) season and the treatment and post treatment phase of the study. Furthermore, subjects will not be excluded if the Investigator may judge the sensitivity as not clinically relevant. Secondary alteration at the affected organ (i.e. emphysema, bronchiectasis). History of autoimmune diseases (e.g. of liver, kidney, thyroid, nervous system), 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, especially in the case of tyrosinemia and alkaptonuria. 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, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis. Documented history of angioedema. Hypersensitivity to excipients in the study medications. Previous or current immunotherapy with comparable ragweed 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),or inadequate washout of any medication. Any systemic disorder that could interfere with the evaluation of the study medication(s). Clinical history (within 2 years) of drug or alcohol abuse that would, in the opinion of the Investigator, interfere with the patient's participation in the study. Patient who has a positive urine drug screen (cocaine metabolites, cannabinoids, opiates, PCP, or amphetamine), or a positive alcohol saliva test. 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
Karl Jürgen Fischer von Weikersthal-Drachenberg, MD
Organizational Affiliation
Allergy Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
Michigan Respiratory Health and Research Institute
City
Novi
State/Province
Michigan
ZIP/Postal Code
48375
Country
United States
Facility Name
Clinical Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Regional Allergy & Asthma Consultants
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Lovelace Scientific Resources
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States

12. IPD Sharing Statement

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