Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-03-11 @ 9:08 PM
Study NCT ID:
NCT02478060
Status:
COMPLETED
Last Update Posted:
2016-11-08
First Post:
2015-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Birch-SPIRE Safety and Efficacy Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2016-11-07', 'studyFirstSubmitDate': '2015-06-11', 'studyFirstSubmitQcDate': '2015-06-18', 'lastUpdatePostDateStruct': {'date': '2016-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Allergy symptoms and allergy medication use during next Birch season', 'timeFrame': 'Up to 9 months after start of dosing'}], 'primaryOutcomes': [{'measure': 'Safety of Birch-SPIRE administrations measured by Adverse Events', 'timeFrame': 'Up to 16 weeks after start of dosing'}], 'secondaryOutcomes': [{'measure': 'Measurement of IgE as a Pharmacodynamic parameter', 'timeFrame': 'Up to 9 months after start of dosing'}, {'measure': 'Conjunctival Provocation Test as a Pharmacodynamic parameter', 'timeFrame': 'Up to 9 months after start of dosing'}, {'measure': 'Skin Prick Testing as a Pharmacodynamic parameter', 'timeFrame': 'Up to 9 months after start of dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Allergy', 'Birch', 'Rhinitis', 'Rhinoconjuntivitis', 'SPIRE', 'Toleromune'], 'conditions': ['Rhinitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of multiple administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic parameters and clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged 18 to 65 years;\n* Minimum 1 year history of rhinitis with or without conjunctivitis on exposure to birch pollen\n* Birch IgE ≥ 0.35 kU/L\n* Positive skin prick test to whole birch allergen\n\nExclusion Criteria:\n\n* Any past history of asthma\n* FEV1 \\< 80% of predicted\n* History of severe allergic reaction to birch allergen, severe drug allergy, severe angioedema or severe allergic reactions to food\n* Acute phase skin response to whole birch allergen with a mean wheal diameter \\> 50mm\n* Administration of adrenaline (epinephrine) is contraindicated\n* History of severe drug allergy or anaphylactic reaction to food.\n* History of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)'}, 'identificationModule': {'nctId': 'NCT02478060', 'briefTitle': 'Birch-SPIRE Safety and Efficacy Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Circassia Limited'}, 'officialTitle': 'A Double-Blind, Randomised, Placebo-Controlled, Escalating, Multiple Dose Study in to Assess the Safety, Tolerability and Pharmacodynamic Effects of Birch-SPIRE', 'orgStudyIdInfo': {'id': 'CB001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Birch-SPIRE or placebo, 2 weeks apart', 'interventionNames': ['Biological: Birch-SPIRE', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Birch-SPIRE or placebo, 2 weeks apart', 'interventionNames': ['Biological: Birch-SPIRE', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Birch-SPIRE or placebo, 2 weeks apart', 'interventionNames': ['Biological: Birch-SPIRE', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'Birch-SPIRE or placebo, 2 weeks apart', 'interventionNames': ['Biological: Birch-SPIRE', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5', 'description': 'Birch-SPIRE or placebo, 2 weeks apart', 'interventionNames': ['Biological: Birch-SPIRE', 'Biological: Placebo']}], 'interventions': [{'name': 'Birch-SPIRE', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 4M6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de Recherche Appliqué en Allergie de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Circassia Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Adiga Life Sciences, Inc.', 'class': 'INDUSTRY'}, {'name': 'Quintiles, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}