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Search / Trial NCT00423787

Efficacy and Safety/Tolerability of Ragweed MATA MPL

Launched by ALLERGY THERAPEUTICS · Jan 17, 2007

Trial Information

Current as of May 04, 2025

Completed

Keywords

Allergy Allergoid Specific Immunotherapy

ClinConnect Summary

Ragweed MATAMPL has been developed by Allergy Therapeutics to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross reacting ragweed pollens causing rhinitis and/or conjunctivitis with or without mild to moderate asthma bronchiale.

An earlier formulation of Ragweed MATAMPL developed by Allergy Therapeutics (UK), Ltd, available commercially in Canada since the 1980's, is 'Pollinex®-R'. 'Pollinex®-R' is formulated with modified allergens (allergoids) of ragweed pollen extract adsorbed onto L tyrosine at 4% w/v. Related formulations developed by...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Have given written informed consent;
  • Are 18 to 59 years of age;
  • history of moderate to severe symptoms of seasonal allergic rhinitis and/or conjunctivitis ascribed to ragweed pollen exposure that required repeated use of antihistamines, nasal steroids, and/or leukotriene modifiers;
  • history of moderate to severe symptoms in the past ragweed pollen season;
  • positive skin prick test to ragweed pollen and a positive RAST or equivalent test to ragweed pollen;
  • positive skin prick test to histamine;
  • negative skin prick test to the negative control;
  • forced expiratory volume in 1 second (FEV1) ≥ 80% of predicted, with a FEV1/FVC ratio ≥ 70%;
  • Women of childbearing potential must be using a medically acceptable method of birth control;
  • able to understand and comply with study instructions;
  • Demonstrate proper use of electronic diary with at least 85% compliance during the 1-week period between Visit 1 and Visit 2.
  • Exclusion Criteria:
  • pregnant or lactating
  • asthma requiring the daily use of controller medication;
  • emergency room visit or admission for asthma in the 12 months prior to Visit 1;
  • presence of secondary alteration at the affected organ (i.e., emphysema, bronchiectasis, nasal polyps, chronic sinusitis);
  • auto-immune disease;
  • acute or subacute (historic) atopic dermatitis, chronic dermatitis, urticaria factitia, and/or urticaria due to physical/chemical influence or any other skin conditions which might interfere with the interpretation of the skin prick test results;
  • history or presence of diabetes, cancer or concomitant illness that, in the opinion of the Investigator, would pose a safety risk or compromise the interpretation of efficacy for this ragweed immunotherapy;
  • history of angioedema;
  • manifest pulmonary or cardiac insufficiency;
  • current malignant disease;
  • disorders of tyrosine metabolism (i.e., alcaptonuria, tyrosinemia);
  • acute or chronic infection;
  • any clinically significant abnormal laboratory value at Visit 1;
  • Perennial Allergens: positive skin prick test at Visit 1 to: house dust mites, molds, or epithelia. In these cases, a careful history is to be taken and if moderate or severe symptoms are reported when exposed to the aforementioned allergens, the subject is to be excluded. Exception: the source of the allergen (cat, dog, horse) can be avoided for the entire study.
  • Springtime Flowering Plant Allergens: positive skin prick test at Visit 1 to birch, oak, sycamore, ash, red maple, black walnut, American elm, or poplar. In these cases, a careful history is to be taken and if moderate to severe symptoms are reported when exposed to the aforementioned allergens the subject is to be excluded. Exception: one 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, the treatment phase of the study can be initiated at least 30 days after the end of the allergen(s) season or treatment can be completed 30 days before the anticipated start of the allergen(s) season.
  • Summertime Flowering Plant Allergens: positive skin prick test at Visit 1 to grass pollen mix or Bermuda grass. In these cases, a careful history is to be taken and if moderate to severe symptoms are reported when exposed to the aforementioned allergens the subject is to be excluded. Exception: No testing is required if there is no overlap between grass / Bermuda grass and ragweed season and if treatment can be completed 30 days before the start of grass / Bermuda grass season. Bermuda grass must not be tested if it is not common to the Investigator's region.
  • Late Summer/Autumn Flowering Plant Allergens: positive skin prick test at Visit 1 to: goosefoot/lamb's quarters, firebush/kochia, or English plantain. In these cases, a careful history is to be taken and if moderate to severe symptoms are reported when exposed to the aforementioned allergens the subject is to be excluded. Exception: some or all of the listed allergens must not be tested if they are not common to the Investigator's region.
  • * Have inadequate washout period prior to screening (Visit 1). The following washout periods prior to Visit 1 are acceptable:
  • Oral or parenteral corticosteroids (1 month)
  • Inhaled, ocular or intranasal corticosteroids (1 day)
  • Mast cell stabilizers (7 days)
  • Intranasal or systemic decongestants including cold preparations (1 day)
  • Leukotriene modifiers (7 days)
  • Afrin (oxymetazoline hydrochloride) (14 days)
  • Antihistamines
  • Once-daily or twice-daily antihistamines (7 days)
  • Short-acting 3 or 4 times a day antihistamines (3 days)
  • Hydroxyzine (14 days)
  • H2-blockers (1 day)
  • Other anti-inflammatory, anti-allergy, and any other medications which, in the opinion of the Investigator, may interfere with the study objectives should be considered on a case-by-case basis
  • Topical skin medications on the forearms (14 days);
  • Require use of beta blockers;
  • Are unable to receive epinephrine therapy (i.e., use of epinephrine is contraindicated);
  • Have a history of anaphylactic reactions to foods, insect venom, exercise, or drugs;
  • Have been treated with a preparation containing MPL® within 6 months prior to Visit 1;
  • Have diseases with a pathogenesis interfering with the immune response, and who have received medication which could interfere with the results of the study;
  • Have a history of allergy, hypersensitivity or intolerance to the excipients of the study medication;
  • Have a history of allergy, hypersensitivity or intolerance to study relief medication;
  • Have already undergone hyposensitisation therapy with comparable allergen extracts; An exception will be allowed if prior immunotherapy with comparable allergen was successful, symptoms reappeared some time after stopping the immunotherapy, and the immunotherapy was completed ≥ 3 years before Visit 1;
  • Have participated in a clinical research trial with a new chemical substance within 4 weeks of Visit 1;
  • Are unable or unwilling to cooperate with the Investigator and to comply with the protocol requirements, or not likely to complete the observation periods sufficiently;
  • Have changed residence between geographical regions within the past 3 months

About Allergy Therapeutics

Allergy Therapeutics is a leading biopharmaceutical company dedicated to the development and commercialization of innovative immunotherapy solutions for allergic diseases. With a strong focus on enhancing patient outcomes, the company leverages its proprietary technology platforms to create effective and safe treatments for various allergies, including pollen, dust mites, and food allergies. Committed to rigorous clinical research and development, Allergy Therapeutics aims to address unmet medical needs in allergy care, ultimately improving the quality of life for individuals suffering from allergic conditions. Through its collaborative approach and commitment to scientific excellence, the company is at the forefront of advancing allergy immunotherapy.

Locations

Minneapolis, Minnesota, United States

St. Louis, Missouri, United States

Richmond, Virginia, United States

Nashville, Tennessee, United States

Sherbrooke, Quebec, Canada

Rochester, New York, United States

Raleigh, North Carolina, United States

Atlanta, Georgia, United States

Asheville, North Carolina, United States

San Antonio, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

Upland, Pennsylvania, United States

Canton, Ohio, United States

Skillman, New Jersey, United States

Raleigh, North Carolina, United States

Bristol, Tennessee, United States

Pittsburgh, Pennsylvania, United States

Teaneck, New Jersey, United States

Hamilton, Ontario, Canada

San Antonio, Texas, United States

Toronto, Ontario, Canada

Stockbridge, Georgia, United States

Sylvania, Ohio, United States

Summit, New Jersey, United States

San Antonio, Texas, United States

Waco, Texas, United States

Kanata, Ontario, Canada

Niagara Falls, Ontario, Canada

Mirabel, Quebec, Canada

Waterbury, Connecticut, United States

Atlanta, Georgia, United States

Conyers, Georgia, United States

Gainesville, Georgia, United States

Lilburn, Georgia, United States

Chicago, Illinois, United States

Normal, Illinois, United States

Iowa City, Iowa, United States

Overland, Kansas, United States

Gardner, Massachusetts, United States

Ypsilanti, Michigan, United States

Plymouth, Minnesota, United States

Omaha, Nebraska, United States

Omaha, Nebraska, United States

Papillion, Nebraska, United States

Ocean, New Jersey, United States

White Plains, New York, United States

Fargo, North Dakota, United States

Altoona, Pennsylvania, United States

Easton, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Chattanooga, Tennessee, United States

Knoxville, Tennessee, United States

Austin, Texas, United States

Austin, Texas, United States

Dallas, Texas, United States

Waco, Texas, United States

South Burlington, Vermont, United States

Richmond, Virginia, United States

Greenfield, Wisconsin, United States

Madison, Wisconsin, United States

Madison, Wisconsin, United States

Menomonee Falls, Wisconsin, United States

Milwaukee, Wisconsin, United States

West Allis, Wisconsin, United States

Burlington, Ontario, Canada

Courtice, Ontario, Canada

Mississauga, Ontario, Canada

Mississauga, Ontario, Canada

North Bay, Ontario, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Quebec, , Canada

Patients applied

0 patients applied

Trial Officials

Karl Jürgen Fischer von Weikersthal-Drachenberg, MD

Study Chair

Allergy Therapeutics

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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