Efficacy and Safety/Tolerability of Ragweed MATA MPL

NCT00423787 | Completed Phase 3 DMC

• 1 other identifier: RagweedMATAMPL301
• Study Type: interventional
• Target: 993
• Locations: 2 countries
• Sites: 76

Brief 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. 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

Conditions

Type I Hypersensitivity

Keywords

Allergy; Allergoid; Specific Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Compare the efficacy of Ragweed MATA MPL versus placebo as measured by the combined allergy symptom (eyes and nose)+ medication scores self-reported by subjects during the 3 peak weeks of the 2007 ragweed pollen season.

  9 months

Secondary Outcomes (2)

• Combined symptom + medication scores, Combined symptoms, Individual symptoms, Relief medication use, Specific immunological changes, quality of life, Health Assessments, Days absent from activities

  9 months

• Adverse events, adverse reactions, clinical labs, ECG, and vitals

  9 months

Study Arms (2)

Ragweed MATA MPL

EXPERIMENTAL

modified Ragweed pollen allergen absorbed to Tyrosine and containing MPL adjuvant

Biological: Ragweed MATA MPL

Placebo

PLACEBO COMPARATOR

4 injections of placebo 0.5 ml (2% tyrosine)

Biological: Ragweed MATA MPL

Interventions

Ragweed MATA MPL BIOLOGICAL

4 injections of increasing dose strength: 1. 300 SU/0.5 ml 2. 700 SU/0.5 ml 3. 2000 SU/0.5 ml 4. 6000 SU/0.5 ml

Placebo; Ragweed MATA MPL

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Allergy Therapeutics: lead

Study Sites (76)

The Centre for Allergy, Asthma & Immunology

Waterbury, Connecticut, 06708, United States

Location

Allergy & Asthma Consultants

Atlanta, Georgia, 30342, United States

Location

Clinical Research Atlanta

Atlanta, Georgia, 30342, United States

Location

DataQuest Medical Research

Conyers, Georgia, 30013, United States

Location

Northeast Georgia Research Center LLC

Gainesville, Georgia, 30501, United States

Location

Allergy and Consultants, PC

Lilburn, Georgia, 30047, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

University Consultants in Allergy/Immunlogy

Chicago, Illinois, 60612, United States

Location

Sneeze, Wheeze and Itch Associates, LLC

Normal, Illinois, 61761, United States

Location

Iowa Clinical Research Corporation

Iowa City, Iowa, 52244, United States

Location

Kansas City Allergy & Asthma

Overland, Kansas, 66210, United States

Location

Allergy & Arthritis Treatment Centre

Gardner, Massachusetts, 01440, United States

Location

Respiratory Medical Research Institute of Michigan

Ypsilanti, Michigan, 48197, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

Clinical Research Institute/West Health Building

Plymouth, Minnesota, 55441, United States

Location

The Clinical Research Center, LLC

St Louis, Missouri, 63141, United States

Location

Midwest Allergy and Asthma Clinic

Omaha, Nebraska, 68130, United States

Location

Creighton University Medical Center Division of Allergy, Asthma and Immunology

Omaha, Nebraska, 68131, United States

Location

The Asthma and Allergy Centre

Papillion, Nebraska, 68046, United States

Location

Atlantic Research Center LLC

Ocean City, New Jersey, 07712, United States

Location

Princeton Center for Clinical Research

Skillman, New Jersey, 08558, United States

Location

Pulmonary & Allergy Associates, P.A.

Summit, New Jersey, 07901, United States

Location

The Medical Center at Teaneck

Teaneck, New Jersey, 07666, United States

Location

AAIR Research Center

Rochester, New York, 14618, United States

Location

Ira Finegold, M.D.

White Plains, New York, 10606, United States

Location

Regional Allergy & Asthma Consultants

Asheville, North Carolina, 28801, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Allergy & Asthma Care Centre

Fargo, North Dakota, 58103, United States

Location

Allergy & Respiratory Center

Canton, Ohio, 44718, United States

Location

Toledo Center for Clinical Research

Sylvania, Ohio, 43560, United States

Location

Dr. Jeffrey Rosch Office and Research Centre

Altoona, Pennsylvania, 16601, United States

Location

Valley Clinical Research Centre

Easton, Pennsylvania, 18045, United States

Location

Allergy and Asthma Research of New Jersey Inc.

Philadelphia, Pennsylvania, 19115, United States

Location

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, 15241, United States

Location

Asthma and Allergy Associates

Upland, Pennsylvania, 19013, United States

Location

Tricities Medical Research

Bristol, Tennessee, 37620, United States

Location

The Asthma Institute, PLLC

Chattanooga, Tennessee, 37421, United States

Location

The Allergy, Asthma & Sinus Centre PA

Knoxville, Tennessee, 37909, United States

Location

Clinical Research Associates, Inc

Nashville, Tennessee, 37203, United States

Location

Allergy & Asthma Associates Research Department

Austin, Texas, 78731, United States

Location

Lovelace Scientific Resources Allergy and Asthma Centre of Austin

Austin, Texas, 78759, United States

Location

AARA Research Centre

Dallas, Texas, 75231, United States

Location

North Texas Institute for Clinical Trials

Fort Worth, Texas, 76132, United States

Location

Allergy & Asthma Associates

Houston, Texas, 77054, United States

Location

Biogenics Research Institute

San Antonio, Texas, 78229, United States

Location

Diagnostic Research Group

San Antonio, Texas, 78229, United States

Location

Sylvana Research Associates

San Antonio, Texas, 78229, United States

Location

Allergy & Asthma Care of Waco

Waco, Texas, 76708, United States

Location

Allergy Asthma Research Institute

Waco, Texas, 76712, United States

Location

Timber Lane Allergy & Asthma Research

South Burlington, Vermont, 05403, United States

Location

Commonwealth Clinic Research Specialists Inc.

Richmond, Virginia, 23226, United States

Location

National Clinical Research

Richmond, Virginia, 23294, United States

Location

Allergy, Asthma & Sinus Centre, S.C.

Greenfield, Wisconsin, 53228, United States

Location

Dean Foundation Medical Research

Madison, Wisconsin, 53715, United States

Location

University of Wisconsin, Madison, School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Centre For Clinical Trials

Menomonee Falls, Wisconsin, 53051, United States

Location

Advanced Healthcare SC

Milwaukee, Wisconsin, 53209, United States

Location

Allergic Diseases SC

West Allis, Wisconsin, 53227, United States

Location

JBN Medical Diagnostic Services Inc.

Burlington, Ontario, L7M 4Y1, Canada

Location

Co-Medica Health Centre

Courtice, Ontario, L1E 3C3, Canada

Location

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Kanata Allergy Services Ltd.

Kanata, Ontario, K2L 3C8, Canada

Location

Allied Research International Inc

Mississauga, Ontario, L4W 1N2, Canada

Location

Alpha Medical Research Inc.

Mississauga, Ontario, L5A 3V4, Canada

Location

Niagara Clinical Research

Niagara Falls, Ontario, L2G 1J4, Canada

Location

Northgate Medical Clinic

North Bay, Ontario, P1B2H3, Canada

Location

Allergy & Asthma Research Centre

Ottawa, Ontario, K1Y 4G2, Canada

Location

Melimar Allergy Laboratory Inc.

Toronto, Ontario, M3H 3S3, Canada

Location

Asthma, Allergy & Immunology

Toronto, Ontario, M4P 1P2, Canada

Location

Gordon Sussman, 202 St. Clair Avenue West

Toronto, Ontario, M4V 1R2, Canada

Location

Manna Research

Toronto, Ontario, M9W 4L6, Canada

Location

Omnispec Clinical Research

Mirabel, Quebec, J7J 2K8, Canada

Location

Division of Clinical Immunology and Allergy, The McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Centre De Recherche Appliquée en Allergie De Quebec

Québec, Quebec, GiV 4M6, Canada

Location

Q&T Research

Sherbrooke, Quebec, J1H 4J6, Canada

Location

MeSH Terms

Conditions

Hypersensitivity, Immediate; Hypersensitivity

Interventions

ragweed MATA MPL

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 17, 2007
• First Posted: January 18, 2007
• Study Start: March 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: March 1, 2008
• Last Updated: June 17, 2010

Record last verified: 2010-06

Locations

US (59); CA (17)