Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-01-04 @ 8:46 AM
Study NCT ID:
NCT00133159
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2005-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Doses of Tyrosine Adsorbed Grass Pollen Allergoid With Monophosphoryl Lipid A (MPL) in Patients Sensitized to Grass Pollen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2005-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-17', 'studyFirstSubmitDate': '2005-08-22', 'studyFirstSubmitQcDate': '2005-08-22', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'immunological response to the three GrassMATAMPL treatment arms compared to placebo (grass specific)'}], 'secondaryOutcomes': [{'measure': 'tolerability of different subcutaneous doses'}, {'measure': 'tolerability of the cumulative subcutaneous doses'}, {'measure': 'clinical chemistry and hematology'}, {'measure': 'number of adverse events'}, {'measure': 'number of adverse reactions'}, {'measure': 'immunological response to the three GrassMATAMPL treatment arms compared to placebo (rye specific)'}]}, 'conditionsModule': {'keywords': ['Allergy', 'Specific Immunotherapy'], 'conditions': ['Type I Hypersensitivity']}, 'descriptionModule': {'briefSummary': 'Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities of an allergen extract to an allergic patient, is a curative approach which directly treats the underlying allergic disease. GrassMATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to grass pollen (hay fever). The purpose of this double-blind Phase IIb study is to assess the tolerability and immunogenicity of different doses of GrassMATAMPL in volunteers allergic to grasses and rye pollen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* positive skin prick test for grass and rye allergen\n* Specific IgE for grass and rye as documented by radioallergosorbent or equivalent test with class \\>= 2\n* History of at least 1 season of moderate to severe seasonal rhinoconjunctivitis due to an IgE - mediated allergy to pollen from grass and rye\n* Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile. Females of childbearing potential have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using an acceptable birth control method.\n* Spirometry at Screening demonstrates FEV1 \\>= 80% predicted and FEV1/FVC \\>= 70%\n\nExclusion Criteria:\n\n* Acute or subacute atopic dermatitis and/or urticaria factitia and/or urticaria due to physical or chemical influence and/or chronic dermatitis\n* Patient has moderate to severe asthma\n* Visual inspection of the forearms indicates potential problems with the conduct or interpretation of the skin prick test; both forearms must be available for testing\n* History or presence of diabetes, cancer or any clinically significant cardiac, metabolic renal, hematologic diseases or disorders\n* Recent clinically significant history (within 2 years) of hepatic gastrointestinal, dermatologic, venereal, neurologic or psychiatric diseases or disorders\n* Any clinically significant (as determined by the investigator) abnormal laboratory value\n* Perennial allergens: clinically relevant sensitivity against house dust mites, molds, and epithelia\n* Patient has clinically relevant sensitivity against the following summer/autumn season flowering plants: plantain, orache, nettle, mugwort, Bermuda grass, or ragweed.\n* Secondary alteration at the affected organ\n* History of autoimmune diseases and/or rheumatoid diseases\n* Patient is taking b-blockers\n* Patient who is not allowed to receive adrenalin\n* Patients in whom tyrosine metabolism is disturbed\n* Presence of a disease with a pathogenesis interfering with the immune response and patient has received medication which could influence the results of this study\n* Documented evidence of acute or significant chronic infection\n* History of anaphylaxis\n* Documented history of angioedema\n* Hypersensitivity to excipients in the study medications\n* Previous or current immunotherapy with comparable grass/rye allergen extracts\n* Currently using anti-allergy medication and other drugs with antihistaminic activity\n* Patients currently participating in a clinical trial or who have been exposed to study medication within the last 30 days\n* Patient is pregnant or planning pregnancy and/or lactating\n* Patient has received treatment with preparation containing MPL® during the past 12 months\n* Any systemic disorder that could interfere with the evaluation of the study medication(s)\n* Clinical history of drug or alcohol abuse that would interfere with the patient's participation in the study"}, 'identificationModule': {'nctId': 'NCT00133159', 'briefTitle': 'Different Doses of Tyrosine Adsorbed Grass Pollen Allergoid With Monophosphoryl Lipid A (MPL) in Patients Sensitized to Grass Pollen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergy Therapeutics'}, 'officialTitle': 'A Double-Blind Phase IIb Study to Evaluate the Safety and Efficacy of Different Doses of Tyrosine Adsorbed Grass/Rye Pollen Allergoid With MPL in Patients Sensitized to Grass and Rye Pollen', 'orgStudyIdInfo': {'id': 'GrassMATAMPL203'}, 'secondaryIdInfos': [{'id': 'P2DP5005'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Grass MATAMPL', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L4W 1N2', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Allied Research International Inc.', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L5B 1N1', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'K1Y 4G2', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Allergy Research Corporation', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Kemi Oluwayi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Allergy Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergy Therapeutics', 'class': 'INDUSTRY'}}}}