Efficacy and Safety/Tolerability of Ragweed MATA MPL

Completed · Phase 3 · Has a placebo group

Conditions studied: Type I Hypersensitivity

In brief

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. The purpose of this study is to compare the efficacy of Ragweed MATAMPL versus placebo in ragweed-allergic subjects following 4 subcutaneous injections of study medication administered before the start of the 2007 ragweed pollen season

Key facts

Study ID

NCT00423787

Run by

Allergy Therapeutics

People needed

993

Starts

2007-03-01

Expected to finish

2008-03-01

Last updated by the study team

2010-06-17

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Allergy & Asthma Consultants — Atlanta, Georgia, United States
• Clinical Research Atlanta — Atlanta, Georgia, United States
• DataQuest Medical Research — Conyers, Georgia, United States
• Northeast Georgia Research Center LLC — Gainesville, Georgia, United States
• Allergy and Consultants, PC — Lilburn, Georgia, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• University Consultants in Allergy/Immunlogy — Chicago, Illinois, United States
• Sneeze, Wheeze and Itch Associates, LLC — Normal, Illinois, United States
• Iowa Clinical Research Corporation — Iowa City, Iowa, United States
• Kansas City Allergy & Asthma — Overland, Kansas, United States
• Allergy & Arthritis Treatment Centre — Gardner, Massachusetts, United States
• Respiratory Medical Research Institute of Michigan — Ypsilanti, Michigan, United States
• Clinical Research Institute — Minneapolis, Minnesota, United States
• Clinical Research Institute/West Health Building — Plymouth, Minnesota, United States
• The Clinical Research Center, LLC — St Louis, Missouri, United States
• Midwest Allergy and Asthma Clinic — Omaha, Nebraska, United States
• Creighton University Medical Center Division of Allergy, Asthma and Immunology — Omaha, Nebraska, United States
• The Asthma and Allergy Centre — Papillion, Nebraska, United States
• Atlantic Research Center LLC — Ocean City, New Jersey, United States
• Princeton Center for Clinical Research — Skillman, New Jersey, United States
• Pulmonary & Allergy Associates, P.A. — Summit, New Jersey, United States
• The Medical Center at Teaneck — Teaneck, New Jersey, United States
• AAIR Research Center — Rochester, New York, United States
• Ira Finegold, M.D. — White Plains, New York, United States
• The Centre for Allergy, Asthma & Immunology — Waterbury, Connecticut, United States

Full record on ClinicalTrials.gov

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