Efficacy and Safety/Tolerability of Grass MATA MPL

NCT00414141 | Completed Phase 3

• 1 other identifier: GrassMATAMPL301
• Study Type: interventional
• Target: 1,028
• Locations: 4 countries
• Sites: 94

Brief Summary

Grass MATA MPL has been developed by Allergy Therapeutics (UK) Ltd. to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross reacting grass 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 Grass MATA MPL versus placebo in grass-allergic subjects following 4 subcutaneous injections of study medication administered before the start of the 2007 grass pollen season.

Conditions

Type I Hypersensitivity

Keywords

Allergy; Allergoid; Specific Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Efficacy of Grass MATA MPL versus placebo measured by combined allergy symptom + medication scores during 4 peak weeks of grass 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)

1

EXPERIMENTAL

Grass MATA MPL

Biological: Grass MATA MPL

2

PLACEBO COMPARATOR

Biological: Placebo

Interventions

Grass MATA MPL BIOLOGICAL

4 subcutaneous injections

1

Placebo BIOLOGICAL

4 subcutaneous injections

Also known as: tyrosine solution

2

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;
• Have a history of moderate to severe symptoms of seasonal allergic rhinitis and/or conjunctivitis ascribed to grass pollen exposure that required repeated use of antihistamines, nasal steroids, and/or leukotriene modifiers;
• Have a history of moderate to severe symptoms in the past grass pollen season as determined by a score of ≥ 5 on the Disease Severity Questionnaire;
• Have a positive skin prick test to grass pollen mix \[wheal (longest diameter) ≥ 5 mm greater than the negative control\] and a positive RAST or equivalent test (class ≥ 2) to grass pollen mix;
• Have a positive skin prick test to histamine \[wheal (longest diameter) of ≥ 3 mm greater than the negative control\];
• Have a negative skin prick test to the negative control (redness with wheal ≤ 2 mm is acceptable);
• Have a 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 \[i.e. double barrier method of contraception (e.g., intrauterine device and condom, spermicide and condom), stable hormonal contraceptive for ≥ 90 days prior to the study or if \< 90 days additional use of a double barrier method until 90 days reached, sexual abstinence or have a vasectomized partner until study completion\], and have a negative β-HCG pregnancy test result at Visits 1 and 2;
• Are able to understand and comply with study instructions;
• Demonstrate proper use of electronic diary with at least 85% compliance (i.e., correct entries for symptoms on 6 of 7 days) during the 1-week period between Visit 1 and Visit 2.

You may not qualify if:

• Are pregnant or lactating
• Have asthma requiring the daily use of controller medication;
• Had an emergency room visit or admission for asthma in the 12 months prior to Visit 1;
• Have the presence of secondary alteration at the affected organ (i.e., emphysema, bronchiectasis, nasal polyps, chronic sinusitis);
• Have auto-immune disease (e.g., liver, kidney, thyroid, nervous system);
• Have 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;
• Have a history or presence of diabetes (both insulin dependent and non-dependent), cancer or concomitant illness (e.g., cardiac, metabolic, renal, hepatic, gastrointestinal, dermatologic, venereal, hematologic, neurologic, or psychiatric diseases or disorders) that, in the opinion of the Investigator, would pose a safety risk or compromise the interpretation of efficacy for this grass immunotherapy;
• Have a history of angioedema;
• Have manifest pulmonary or cardiac insufficiency;
• Have current malignant disease;
• Have disorders of tyrosine metabolism (i.e., alcaptonuria, tyrosinemia);
• Have an acute or chronic infection;
• Have any clinically significant abnormal laboratory value (as determined by the Investigator) at Visit 1;
• Perennial Allergens: Have a positive skin prick test \[wheal (longest diameter) ≥ 3mm greater than the negative control\] at Visit 1 to: house dust mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae), molds (Cladosporium cladosporioides, Alternaria alternata, Penicillium chrysogenum, and Aspergillus fumigatus), or epithelia (cat, dog, and horse). 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. Subjects with mild or no symptoms when exposed to the aforementioned allergens during the 3 years prior to Visit 1 will be allowed to enroll. Mild symptoms are defined as: sign/symptom clearly present, but minimal awareness; easily tolerated;
• Only for the USA and Canada:Autumn/Winter Flowering Plant Allergens: Have a positive skin prick test \[wheal (longest diameter) ≥ 3mm greater than the negative control\] at Visit 1 to: ragweed (Ambrosia sp.) or mountain cedar/mountain juniper (Juniperus ashei). 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 both 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. Subjects with mild or no symptoms when exposed to the aforementioned allergens during the 3 years prior to Visit 1 will be allowed to enroll. Mild symptoms are defined as: sign/symptom clearly present, but minimal awareness, easily tolerated;

Sponsors & Collaborators

• Allergy Therapeutics: lead

Study Sites (94)

Asthma & Allergy Associates, PC & Research Center

Colorado Springs, Colorado, 80907, United States

Location

Colorado Allergy & Asthma Centers, PC

Denver, Colorado, 80230, United States

Location

Colorado Allergy and Asthma Clinic, PC

Englewood, Colorado, 80112, United States

Location

Dr. Dreyfus

Waterbury, Connecticut, 06708-3104, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Sneeze, Wheeze & Itch Associates

Normal, Illinois, 61761, United States

Location

The Allergy and Asthma Center

Fort Wayne, Indiana, 46804, United States

Location

Medical Associates Clinic

Dubuque, Iowa, 52002, United States

Location

Iowa Clinical Research Corporation

Iowa City, Iowa, 52240, United States

Location

Kansas City Allergy and Asthma Associates, PA

Overland Park, Kansas, 66210, United States

Location

Brigham & Women's Hospital, Rheumatology & Immunology, Smith Building Rm 626

Boston, Massachusetts, 02115, United States

Location

"The Allergy & Arthritis Family Treatment Centers

Gardner, Massachusetts, 01440, United States

Location

McGovern Allergy Associates, PC

Springfield, Massachusetts, 01103, United States

Location

Respiratory Medicine Researdh Institute of Michigan, PLC

Ypsilanti, Michigan, 48197, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

Clinical Research Institute

Plymouth, Minnesota, 55441, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Montana Allergy and Asthma 2900 12th Avenue North Suite 302E

Billings, Montana, 59101, United States

Location

Montana Medical Research

Missoula, Montana, 59808, United States

Location

Midwest Allegy and Asthma Clinic

Omaha, Nebraska, 68130, United States

Location

Creighton University - Allergy & Immunology

Omaha, Nebraska, 68131, United States

Location

Nebraska Medical Research Institute

Papillion, Nebraska, 68046, United States

Location

Allergy & Asthma Center

Marlboro, New Jersey, 07746, United States

Location

Princeton Center for Clinical Research Montgomery Professional Center

Skillman, New Jersey, 08558, United States

Location

The Medical Center at Teaneck

Teaneck, New Jersey, 07666, United States

Location

Allergy Consultants, PA

Verona, New Jersey, 07044, United States

Location

Asthma and Allergy Associates, PC

Cortland, New York, 13045, United States

Location

Asthma and Allergy Associates, PC

Elmira, New York, 14901, United States

Location

Aair Research Center

Rochester, New York, 14618, United States

Location

Island Medical Research, PC

Rockville Centre, New York, 11570, United States

Location

Allergy & Asthma Care Center

Fargo, North Dakota, 58103, United States

Location

Merit Care Health

Fargo, North Dakota, 58122, United States

Location

Allergy and Respiratory Center

Canton, Ohio, 44718, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Clinical Research Source, Inc.

Perrysburg, Ohio, 43551, United States

Location

Toledo Center for Clinical Research

Sylvania, Ohio, 43560, United States

Location

Allergy & Asthma Research Group

Eugene, Oregon, 97401, United States

Location

Allergy, Asthma and Dermatology Research Center, L.L.C.

Lake Oswego, Oregon, 97035, United States

Location

Clinical Research Institute of Southern

Medford, Oregon, 97504, United States

Location

Allergy Associates Research Center, LLC

Portland, Oregon, 97213, United States

Location

MD Office and Research

Altoona, Pennsylvania, 16601, United States

Location

Asthma & Allergy Research Assoc Presidents House

Chester, Pennsylvania, 19013, United States

Location

Penn State University Hershey Medical Center, Dept of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Allergy and Asthma Research of NJ

Philadelphia, Pennsylvania, 19115, United States

Location

Allergy & Clinical Immunology Associates

Pittsburgh, Pennsylvania, 15241, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

Allergy Asthma Immunology Clin RI,Ltd

Providence, Rhode Island, 02903, United States

Location

Asthma Immunology & Allergy

Chattanooga, Tennessee, 37421, United States

Location

The Allergy, Asthma, and Sinus Center 801 Weisgarber Road

Knoxville, Tennessee, 37909, United States

Location

Intermountain Clinical Research

Draper, Utah, 84020, United States

Location

Allergy Associates of Utah

Murray, Utah, 84107, United States

Location

Clinical Research Specialists of Utah

Spanish Fork, Utah, 84660, United States

Location

Timber Lane Allergy & Asthma Research, LLC

South Burlington, Vermont, 05403, United States

Location

Bellingham Asthma And Allergy Associates

Bellingham, Washington, 98225, United States

Location

Physicians Pharmaceutical Study Services

Everett, Washington, 98201, United States

Location

Marycliff Allergy Specialists

Spokane, Washington, 99204, United States

Location

Spokane Allergy & Asthma Clinical Research

Spokane, Washington, 99204, United States

Location

Pulmonary Consultants, P.L.L.C.

Tacoma, Washington, 98405, United States

Location

Allergy Asthma and Sinus Center

Greenfield, Wisconsin, 53228, United States

Location

Dean Foundation for Health Research & Education, Inc.Med Reseach Dept.

Madison, Wisconsin, 53715, United States

Location

Advanced Healthcare Clinical Research Center

Milwaukee, Wisconsin, 53209, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Allergic Diseases, SC

West Allis, Wisconsin, 53227, United States

Location

Universitätsklinik für Umweltdermatologie

Graz, 8036, Austria

Location

Universitätsklinik für Dermatologie und Venerologie

Innsbruck, 6020, Austria

Location

Allgemeines Krankenhaus der Stadt Wien - Universitätsklinik für Dermatologie

Vienna, 1090, Austria

Location

Allergie-Zentrum Wien West

Vienna, 1150, Austria

Location

Kelowna Allergy and Respiratory Health Clinic

Kelowna, British Columbia, V1Y 9L7, Canada

Location

Hamilton Medical Research Group

Hamilton, Ontario, L8M 1K7, Canada

Location

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Kanata Allergy Services Ltd.

Kanata, Ontario, K2L 3C8, Canada

Location

Allied Research International

Mississauga, Ontario, L4W 1N2, Canada

Location

Alpha Medical Research Inc.

Mississauga, Ontario, L5B1N1, Canada

Location

Niagara Clinical Research

Niagara Falls, Ontario, L2G 1J4, Canada

Location

Northgate Medical Clinic

North Bay, Ontario, P1B 2H3, Canada

Location

Allergy and Asthma Research Centre

Ottawa, Ontario, K1Y 4G2, Canada

Location

Filderman R.

Toronto, Ontario, M3H3S3, Canada

Location

Knight A.

Toronto, Ontario, M4P 1P2, Canada

Location

Sussman G.

Toronto, Ontario, M4V 1R2, Canada

Location

Manna Research

Toronto, Ontario, M9W 4L6, Canada

Location

Omnispec Clinical Research

Mirabel, Quebec, J7J 2K8, Canada

Location

The McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Centre De Recherche Appliquée en Allergie De Québec

Québec, Quebec, GiV 4M6, Canada

Location

Q&T Research

Sherbrooke, Quebec, J1H4J6, Canada

Location

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Brighton General Hospital Dept. Respiratory Medicine

Brighton, BN2 3EW, United Kingdom

Location

Addenbrookes Hospital

Cambridge, CB2 2QQ, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, DD1 4HN, United Kingdom

Location

Glenfield Hospital

Leicester, LE3 9PQ, United Kingdom

Location

Guys Hospital

London, SE1 9RT, United Kingdom

Location

Lung Function - Northwest Lung Center

Manchester, M23 9LP, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6Y, United Kingdom

Location

Related Publications (1)

• Frew AJ, DuBuske L, Keith PK, Corrigan CJ, Aberer W, Fischer von Weikersthal-Drachenberg KJ. Assessment of specific immunotherapy efficacy using a novel placebo score-based method. Ann Allergy Asthma Immunol. 2012 Nov;109(5):342-347.e1. doi: 10.1016/j.anai.2012.08.013.

  PMID: 23062390 DERIVED

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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2006
• First Posted: December 21, 2006
• Study Start: November 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: November 1, 2007
• Last Updated: June 17, 2010

Record last verified: 2009-09

Locations

GB (8); US (65); CA (17); AU (4)