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Type I HypersensitivityPhase 3NCT00423787

Efficacy and Safety/Tolerability of Ragweed MATA MPL

A Phase 3 study testing Ragweed MATA MPL in people with Type I Hypersensitivity, run by Allergy Therapeutics at 76 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 59 years
Conditions the study is for
Type I Hypersensitivity
What is being tested?
Ragweed MATA MPL
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
993 participants
Where
76 sitesin 2 countries
Study dates
Mar 2007to Mar 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
Show all 42Show fewer
  • 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

Trial locations and contacts

76 sites in 2 countries.

76 sites in 2 countries

United States59 sites

  • Dr. Jeffrey Rosch Office and Research Centre

    Altoona, Pennsylvania, 16601

  • Regional Allergy & Asthma Consultants

    Asheville, North Carolina, 28801

  • Allergy & Asthma Consultants

    Atlanta, Georgia, 30342

  • Clinical Research Atlanta

    Atlanta, Georgia, 30342

  • Allergy & Asthma Associates Research Department

    Austin, Texas, 78731

  • Lovelace Scientific Resources Allergy and Asthma Centre of Austin

    Austin, Texas, 78759

  • Tricities Medical Research

    Bristol, Tennessee, 37620

  • Allergy & Respiratory Center

    Canton, Ohio, 44718

  • The Asthma Institute, PLLC

    Chattanooga, Tennessee, 37421

  • University Consultants in Allergy/Immunlogy

    Chicago, Illinois, 60612

  • DataQuest Medical Research

    Conyers, Georgia, 30013

  • AARA Research Centre

    Dallas, Texas, 75231

  • Valley Clinical Research Centre

    Easton, Pennsylvania, 18045

  • Allergy & Asthma Care Centre

    Fargo, North Dakota, 58103

  • North Texas Institute for Clinical Trials

    Fort Worth, Texas, 76132

  • Northeast Georgia Research Center LLC

    Gainesville, Georgia, 30501

  • Allergy & Arthritis Treatment Centre

    Gardner, Massachusetts, 01440

  • Allergy, Asthma & Sinus Centre, S.C.

    Greenfield, Wisconsin, 53228

  • Allergy & Asthma Associates

    Houston, Texas, 77054

  • Iowa Clinical Research Corporation

    Iowa City, Iowa, 52244

  • The Allergy, Asthma & Sinus Centre PA

    Knoxville, Tennessee, 37909

  • Allergy and Consultants, PC

    Lilburn, Georgia, 30047

  • Dean Foundation Medical Research

    Madison, Wisconsin, 53715

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

    Madison, Wisconsin, 53792

  • Centre For Clinical Trials

    Menomonee Falls, Wisconsin, 53051

  • Advanced Healthcare SC

    Milwaukee, Wisconsin, 53209

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • Clinical Research Associates, Inc

    Nashville, Tennessee, 37203

  • Sneeze, Wheeze and Itch Associates, LLC

    Normal, Illinois, 61761

  • Atlantic Research Center LLC

    Ocean City, New Jersey, 07712

  • Midwest Allergy and Asthma Clinic

    Omaha, Nebraska, 68130

  • Creighton University Medical Center Division of Allergy, Asthma and Immunology

    Omaha, Nebraska, 68131

  • Kansas City Allergy & Asthma

    Overland, Kansas, 66210

  • The Asthma and Allergy Centre

    Papillion, Nebraska, 68046

  • Allergy and Asthma Research of New Jersey Inc.

    Philadelphia, Pennsylvania, 19115

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania, 15241

  • Clinical Research Institute/West Health Building

    Plymouth, Minnesota, 55441

  • North Carolina Clinical Research

    Raleigh, North Carolina, 27607

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Commonwealth Clinic Research Specialists Inc.

    Richmond, Virginia, 23226

  • National Clinical Research

    Richmond, Virginia, 23294

  • AAIR Research Center

    Rochester, New York, 14618

  • Biogenics Research Institute

    San Antonio, Texas, 78229

  • Diagnostic Research Group

    San Antonio, Texas, 78229

  • Sylvana Research Associates

    San Antonio, Texas, 78229

  • Princeton Center for Clinical Research

    Skillman, New Jersey, 08558

  • Timber Lane Allergy & Asthma Research

    South Burlington, Vermont, 05403

  • The Clinical Research Center, LLC

    St Louis, Missouri, 63141

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Pulmonary & Allergy Associates, P.A.

    Summit, New Jersey, 07901

  • Toledo Center for Clinical Research

    Sylvania, Ohio, 43560

  • The Medical Center at Teaneck

    Teaneck, New Jersey, 07666

  • Asthma and Allergy Associates

    Upland, Pennsylvania, 19013

  • Allergy & Asthma Care of Waco

    Waco, Texas, 76708

  • Allergy Asthma Research Institute

    Waco, Texas, 76712

  • The Centre for Allergy, Asthma & Immunology

    Waterbury, Connecticut, 06708

  • Allergic Diseases SC

    West Allis, Wisconsin, 53227

  • Ira Finegold, M.D.

    White Plains, New York, 10606

  • Respiratory Medical Research Institute of Michigan

    Ypsilanti, Michigan, 48197

Other trials in United States

Canada17 sites

  • JBN Medical Diagnostic Services Inc.

    Burlington, Ontario, L7M 4Y1

  • Co-Medica Health Centre

    Courtice, Ontario, L1E 3C3

  • McMaster University

    Hamilton, Ontario, L8N 3Z5

  • Kanata Allergy Services Ltd.

    Kanata, Ontario, K2L 3C8

  • Omnispec Clinical Research

    Mirabel, Quebec, J7J 2K8

  • Allied Research International Inc

    Mississauga, Ontario, L4W 1N2

  • Alpha Medical Research Inc.

    Mississauga, Ontario, L5A 3V4

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

    Montreal, Quebec, H3G 1A4

  • Niagara Clinical Research

    Niagara Falls, Ontario, L2G 1J4

  • Northgate Medical Clinic

    North Bay, Ontario, P1B2H3

  • Allergy & Asthma Research Centre

    Ottawa, Ontario, K1Y 4G2

  • Centre De Recherche Appliquée en Allergie De Quebec

    Québec, Quebec, GiV 4M6

  • Q&T Research

    Sherbrooke, Quebec, J1H 4J6

  • Melimar Allergy Laboratory Inc.

    Toronto, Ontario, M3H 3S3

  • Asthma, Allergy & Immunology

    Toronto, Ontario, M4P 1P2

  • Gordon Sussman, 202 St. Clair Avenue West

    Toronto, Ontario, M4V 1R2

  • Manna Research

    Toronto, Ontario, M9W 4L6

Other trials in Canada

About this study

Official title: Efficacy and Safety/Tolerability of Ragweed MATA MPL, a Randomized, Placebo-Controlled, Double-Blind Study

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

Read the detailed description

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 ATL, available commercially in selected European countries since the 1970´s on a Named Patient Basis, are 'Pollinex Tree', 'Pollinex Grass', 'Pollinex Quattro Trees' (previously known as MATA tree + MPL), and 'Pollinex Quattro Grass' (previously known as MATA grass + MPL).

Ragweed MATAMPL contains an extract of ragweed pollens. This extract is chemically modified with glutaraldehyde to produce the active ingredient, an allergoid. Such modification reduces the reactivity of the extract with IgE antibody. However, a simultaneous reduction in other important immunological properties, such as IgG and T cell reactivity is not seen. The modified extract is adsorbed to L-tyrosine as a depot formulation. MPL®, a purified, detoxified glycolipid derived from the cell walls of Salmonella minnesota, is also included in the current product formulation. This excipient/adjuvant is included to increase the immunogenic effect of the product and to enhance the switch from an allergen-specific TH2 to TH1-like T cell profile.

The current formulation is designed to provide a product that will be efficacious with only 4 injections, in contrast to the longer schedules currently in use with unmodified extracts. The product will also be safer to use than a formulation containing a similar mass of unmodified allergen extract as regards its ability to cause severe local allergic reactions or anaphylaxis, because of its reduced reactivity with IgE antibody. The modification is greater than 75%, so that only a small amount of unmodified allergen is remaining in the product.

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.

Being tested
Ragweed MATA MPL
Keywords
Allergy, Allergoid, Specific Immunotherapy
Medical subject headings
Hypersensitivity, Immediate, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ragweed MATA MPLBiological

    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
Study groups in NCT00423787
Study groupRoleWhat they receive
Ragweed MATA MPLExperimentalmodified Ragweed pollen allergen absorbed to Tyrosine and containing MPL adjuvant
Receives: Biological: Ragweed MATA MPL
PlaceboPlacebo comparator4 injections of placebo 0.5 ml (2% tyrosine)
Receives: Biological: Ragweed MATA MPL

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 9 months

Secondary outcomes (2)

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

    Measured: 9 months

  2. Adverse events, adverse reactions, clinical labs, ECG, and vitals

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionNov 2007
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
993 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00423787
Sponsor's protocol ID
RagweedMATAMPL301
Status last verified
Jun 2010
First submitted
17 Jan 2007
Last updated
17 Jun 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ragweed MATA MPL in people with Type I Hypersensitivity, run by Allergy Therapeutics at 76 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00423787.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2010.

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