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

NCT00258635 | Completed Phase 2

• 1 other identifier: RagweedMATAMPL203
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 4

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.

Conditions

Type I Hypersensitivity

Keywords

Allergy; Specific Immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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).

  9 weeks

Secondary Outcomes (7)

• Residual allergenicity of modified Ragweed pollen in RagweedMATAMPL compared to unmodified native allergen using Skin Prick Test;

  20 minutes and 6 hours after skin prick test

• Tolerability of native, modified allergens and tyrosine adsorbents with and without MPL® using Skin Prick Test;

  20 minutes and 6 hours after skin prick test

• Tolerability of different subcutaneous doses;

  9 weeks

• Tolerability of the cumulative subcutaneous doses;

  9 weeks

• Clinical chemistry, hematology and urinalysis;

  9 weeks

Interventions

RagweedMATAMPL BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• 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.

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 (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.

Sponsors & Collaborators

• Allergy Therapeutics: lead

Study Sites (4)

Michigan Respiratory Health and Research Institute

Novi, Michigan, 48375, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

Regional Allergy & Asthma Consultants

Asheville, North Carolina, 28801, United States

Location

Lovelace Scientific Resources

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Hypersensitivity, Immediate; Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Karl Jürgen Fischer von Weikersthal-Drachenberg, MD

  Allergy Therapeutics

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 25, 2005
• First Posted: November 28, 2005
• Study Start: November 1, 2005
• Primary Completion: August 7, 2006
• Study Completion: August 7, 2006
• Last Updated: June 11, 2021

Record last verified: 2021-06

Locations

US (4)