Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-03 @ 5:58 AM
Study NCT ID:
NCT03570957
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2018-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2018-06-18', 'studyFirstSubmitQcDate': '2018-06-18', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability as measured by incidence of adverse events', 'timeFrame': 'Up to Day 113'}, {'measure': 'Proportion of subjects who develop antibodies against MT-2990 in serum', 'timeFrame': 'Up to Day 113'}], 'secondaryOutcomes': [{'measure': 'MT-2990 concentration in serum', 'timeFrame': 'Up to Day 113'}, {'measure': 'Maximum observed serum concentration (Cmax) of MT-2990', 'timeFrame': 'Up to Day 113'}, {'measure': 'Measured time of maximum observed serum concentration (tmax) of MT-2990', 'timeFrame': 'Up to Day 113'}, {'measure': 'Apparent terminal elimination half-life (t1/2) of MT-2990', 'timeFrame': 'Up to Day 113'}, {'measure': 'AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990', 'timeFrame': 'Up to Day 113'}, {'measure': 'AUC from time zero to infinity (AUC0-∞) of MT-2990', 'timeFrame': 'Up to Day 113'}, {'measure': 'Terminal elimination rate constant (kel) of MT-2990', 'timeFrame': 'Up to Day 113'}, {'measure': 'Apparent volume of distribution at steady state (Vss) of MT-2990', 'timeFrame': 'Up to Day 113'}, {'measure': 'Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990', 'timeFrame': 'Up to Day 113'}, {'measure': 'Mean residence time from time zero to infinity (MRT0-∞) of MT-2990', 'timeFrame': 'Up to Day 113'}, {'measure': 'Apparent serum clearance (CL) of MT-2990', 'timeFrame': 'Up to Day 113'}, {'measure': 'Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990', 'timeFrame': 'Up to Day 113'}, {'measure': 'Total nasal symptom score (TNSS)', 'timeFrame': 'Day 8, 29, 57, and 85', 'description': 'Four nasal symptoms (runny nose, sneezing, blocked nose, and itchy nose) are recorded using a 5-point scale of 0 (none) to 4 (very severe). TNSS is sum of 4 nasal symptoms, score range is 0 to 16.'}, {'measure': 'Total ocular symptom score (TOSS)', 'timeFrame': 'Day 8, 29, 57, and 85', 'description': 'Two ocular symptoms (itchy eyes and watery eyes) are recorded using a 5-point scale of 0 (none) to 4 (very severe). TOSS is sum of 2 ocular symptoms, score range is 0 to 8.'}, {'measure': 'Total symptom score (TSS)', 'timeFrame': 'Day 8, 29, 57, and 85', 'description': 'TSS is TNSS plus TOSS.'}, {'measure': 'Change from baseline in TNSS', 'timeFrame': 'Day 8, 29, 57, and 85', 'description': 'Baseline is pre-exposure.'}, {'measure': 'Change from baseline in TOSS', 'timeFrame': 'Day 8, 29, 57, and 85'}, {'measure': 'Change from baseline in TSS', 'timeFrame': 'Day 8, 29, 57, and 85'}, {'measure': 'Sum of TNSS during allergen exposure in EEC', 'timeFrame': 'Day 8, 29, 57, and 85'}, {'measure': 'Sum of TOSS during allergen exposure in EEC', 'timeFrame': 'Day 8, 29, 57, and 85'}, {'measure': 'Sum of TSS during allergen exposure in EEC', 'timeFrame': 'Day 8, 29, 57, and 85'}, {'measure': 'AUC of TNSS after allergen exposure', 'timeFrame': 'Day 8, 29, 57, and 85'}, {'measure': 'AUC of TOSS after allergen exposure', 'timeFrame': 'Day 8, 29, 57, and 85'}, {'measure': 'AUC of TSS after allergen exposure', 'timeFrame': 'Day 8, 29, 57, and 85'}, {'measure': 'Proportion of subjects with increased TNSS from baseline', 'timeFrame': 'Day 8, 29, 57, and 85'}, {'measure': 'Proportion of subjects with increased TOSS from baseline', 'timeFrame': 'Day 8, 29, 57, and 85'}, {'measure': 'Proportion of subjects with increased TSS from baseline', 'timeFrame': 'Day 8, 29, 57, and 85'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Seasonal Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the safety, tolerability, and pharmacokinetics of MT-2990 in patients with Japanese cedar pollen-induced seasonal allergic rhinitis (JC-SAR). Additional objective of the study is to investigate the efficacy and pharmacodynamics profile of MT-2990 in an environmental exposure chamber (EEC) on Day 8, 29, 57, and 85.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A body weight of 40 to 100 kg for female or 45 to 100 kg for male\n* A body mass index of 18 to 30 kg/m2\n* Subjects who have current history of JC-SAR in previous 2 consecutive years.\n* Presence (CAP-RAST: ≥2) of IgE specific to Japanese cedar pollens and absence (CAP-RAST: ≤1) of IgE specific to other 4 allergens\n* Presence of at least 2 symptoms, which are moderate to very severe, in 4 nasal symptoms (runny nose, sneezing, blocked nose, itchy nose) at any time point during allergen exposure in EEC at screening period\n\nExclusion Criteria:\n\n* Presence of any symptoms of allergic rhinitis within 1 year except scattering season of cedar pollen or cypress pollen\n* Subjects who have persistent symptom caused by allergen exposure in EEC at screening period until Day 1 (pre-dose)\n* Underwent nasal surgery (include laser surgery) to improve nasal symptoms within 2 years\n* Underwent specific immunotherapy or non-specific immunotherapy within 5 years\n* Underwent medication of anti-histamine, oral mast cell stabilizer, leukotriene receptor antagonist, prostaglandin D2/thromboxane A2 receptor antagonist, Th2 cytokine inhibitor, corticosteroid (oral form, intra-nasal form, ocular form), or vasoconstrictor within 4 weeks\n* Underwent medication of corticosteroid (injection form) or anti-IgE antibody within 6 months\n* Subject who is concerned about exacerbation of the physical condition due to allergen exposure in EEC'}, 'identificationModule': {'nctId': 'NCT03570957', 'briefTitle': 'A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients (Single Dose Study)', 'orgStudyIdInfo': {'id': 'MT-2990-J01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MT-2990, Low dose', 'description': 'Single intravenous dose', 'interventionNames': ['Drug: MT-2990', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MT-2990, Low-middle dose', 'description': 'Single intravenous dose', 'interventionNames': ['Drug: MT-2990', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MT-2990, High-middle dose', 'description': 'Single intravenous dose', 'interventionNames': ['Drug: MT-2990', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MT-2990, High dose', 'description': 'Single intravenous dose', 'interventionNames': ['Drug: MT-2990']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single intravenous dose', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MT-2990', 'type': 'DRUG', 'description': 'MT-2990 solution for injection in vial', 'armGroupLabels': ['MT-2990, High dose', 'MT-2990, High-middle dose', 'MT-2990, Low dose', 'MT-2990, Low-middle dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo solution for injection in vial', 'armGroupLabels': ['MT-2990, High-middle dose', 'MT-2990, Low dose', 'MT-2990, Low-middle dose', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'General Manager', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanabe Pharma Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}