Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-06 @ 7:09 PM
Study NCT ID:
NCT02945657
Status:
COMPLETED
Last Update Posted:
2018-11-19
First Post:
2016-10-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
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The Institution and Investigator agree not to publish the results of the study without prior written consent of the Sponsor, which consent may be withheld by Sponsor for any or no reason.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to 4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'MM36 Topical Ointment, 1%', 'description': 'MM36 topical ointment, 1%, applied twice daily for 15 days', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 7, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Application site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Eosinophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of MM36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 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'populationDescription': 'Pharmacokinetic (PK) population included participants in the Safety Population with PK Data'}, {'type': 'SECONDARY', 'title': 'Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MM36 Topical Ointment, 1%', 'description': 'MM36 topical ointment, 1%, applied twice daily for 28 days'}], 'classes': [{'title': 'No AE', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'AE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 4 weeks', 'description': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all subjects in the Intent to treat (ITT) population who had at least one post-baseline safety assessment'}, {'type': 'SECONDARY', 'title': 'Treatment-Emergent Adverse Events (AEs) According to Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MM36 Topical Ointment, 1%', 'description': 'MM36 topical ointment, 1%, applied twice daily for 28 days'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 4 weeks', 'description': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) According to Severity. 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'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Panama', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Honduras', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Percentage of Body Surface Area (BSA) Involved', 'classes': [{'categories': [{'measurements': [{'value': '43.7', 'spread': '13.25', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-18', 'size': 1302908, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-10-16T15:12', 'hasProtocol': False}, {'date': '2017-01-30', 'size': 1539019, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-10-16T15:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-14', 'studyFirstSubmitDate': '2016-10-21', 'resultsFirstSubmitDate': '2018-10-16', 'studyFirstSubmitQcDate': '2016-10-24', 'lastUpdatePostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-14', 'studyFirstPostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of MM36', 'timeFrame': 'Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1', 'description': 'Maximum observed plasma concentration of MM36 on Day 1'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of MM36', 'timeFrame': 'Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15', 'description': 'Maximum observed plasma concentration of MM36 after two weeks of twice daily application (steady state)'}, {'measure': 'Time of Maximum Observed Plasma Concentration (Tmax) of MM36', 'timeFrame': 'Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1', 'description': 'Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 1'}, {'measure': 'Time of Maximum Observed Plasma Concentration (Tmax) of MM36', 'timeFrame': 'Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15', 'description': 'Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 15'}, {'measure': 'Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36', 'timeFrame': 'Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1', 'description': 'Area Under the Plasma Concentration-time Curve from Time Zero To the time of Last Quantifiable Plasma Concentration of MM36 on Day 1'}, {'measure': 'Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36', 'timeFrame': 'Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15', 'description': 'Area Under the Plasma Concentration-Time Curve From Time Zero To the time of Last Quantifiable Plasma Concentration of MM36 on Day 15'}], 'secondaryOutcomes': [{'measure': 'Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'up to 4 weeks', 'description': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)'}, {'measure': 'Treatment-Emergent Adverse Events (AEs) According to Severity', 'timeFrame': 'up to 4 weeks', 'description': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) According to Severity. Adverse events were classified according to severity as: mild - an event that is usually transient in nature and generally not interfering with normal activities; moderate - an event that is sufficiently discomforting to interfere with normal activities; severe - an event that is incapacitating with inability to work or do usual activity or inability to work or perform normal daily activity.'}, {'measure': 'Application Site Adverse Events (AEs)', 'timeFrame': 'up to 4 weeks', 'description': 'Number of Participants With Application Site Adverse Events (AEs)'}, {'measure': 'Application Site Adverse Events (AEs) According to Severity', 'timeFrame': 'up to 4 weeks', 'description': 'Number of Participants With Application Site Adverse Events (AEs) According to Severity. Adverse events were classified according to severity as: mild - an event that is usually transient in nature and generally not interfering with normal activities; moderate - an event that is sufficiently discomforting to interfere with normal activities; severe - an event that is incapacitating with inability to work or do usual activity or inability to work or perform normal daily activity.'}, {'measure': 'Clinically Meaningful Laboratory Test Median Changes From Baseline', 'timeFrame': 'Day 29', 'description': "Number of Participants With Clinically Meaningful Laboratory Test Median Changes From Baseline. Clinical meaningfulness of laboratory test changes was determined at the investigator's discretion."}, {'measure': 'Clinically Meaningful Vital Sign Median Changes From Baseline', 'timeFrame': 'Day 29', 'description': "Number of Participants With Clinically Meaningful Vital Sign Median Changes From Baseline. Clinical meaningfulness of vital sign changes was determined at the investigator's discretion."}, {'measure': 'Clinically Meaningful ECG Median Changes From Baseline to Day 15', 'timeFrame': 'Day 15', 'description': "Number of Participants With Clinically Meaningful ECG Median Changes from Baseline. Clinical meaningfulness of ECG changes was determined at the investigator's discretion."}, {'measure': 'Clinically Meaningful ECG Median Changes From Baseline to Day 29', 'timeFrame': 'Day 29', 'description': "Number of Participants With Clinically Meaningful ECG Median Changes from Baseline. Clinical meaningfulness of ECG changes was determined at the investigator's discretion."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the pharmacokinetic parameters and safety of topical MM36 (OPA-15406) ointment in pediatric subjects with atopic dermatitis under maximal use conditions.', 'detailedDescription': 'This is a multi-center, open-label study to assess the degree of systemic exposure and safety of MM36 1% ointment following 4 weeks of twice daily dosing under maximal-use conditions in pediatric subjects with atopic dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects 2 to \\<18 years of age\n* Diagnosis of atopic dermatitis (AD)\n* AD affecting ≥ 35% body surface area (BSA) if 2 to \\< 12 years of age or ≥ 25% if subject is ≥ 12 years of age (excluding scalp and venous access areas)\n\nExclusion Criteria:\n\n* Active or acute viral skin infection\n* History of recurrent bacterial infection\n* Malignancy\n* Clinically significant history or physical findings that may pose a health risk to subject or may have an impact on study assessments'}, 'identificationModule': {'nctId': 'NCT02945657', 'briefTitle': 'Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medimetriks Pharmaceuticals, Inc'}, 'officialTitle': 'Protocol MEDI-MM36-206: A Phase 2 Multi-center, Open-label Study to Assess Pharmacokinetic Parameters and Safety of Topical MM36 (1%) in Pediatric Subjects 2 to < 18 Years of Age With Atopic Dermatitis Under Maximal Use Conditions', 'orgStudyIdInfo': {'id': 'MEDI-MM36-206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MM36 1% ointment', 'description': 'MM36 topical ointment, 1%, applied twice daily for 28 days', 'interventionNames': ['Drug: MM36 topical ointment, 1%']}], 'interventions': [{'name': 'MM36 topical ointment, 1%', 'type': 'DRUG', 'otherNames': ['OPA-15406'], 'description': 'Twice daily application for 28 consecutive days', 'armGroupLabels': ['MM36 1% ointment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Medimetriks Investigational Site', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Medimetriks Investigational Site', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medimetriks Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Medimetriks Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '64506', 'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'facility': 'Medimetriks Investigational Site', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Medimetriks Investigational Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Medimetriks Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Medimetriks Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Medimetriks Investigational Site', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Medimetriks Investigational Site', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'city': 'San Pedro Sula', 'country': 'Honduras', 'facility': 'Medimetriks Investigational Site', 'geoPoint': {'lat': 15.50585, 'lon': -88.02588}}, {'city': 'Panama City', 'country': 'Panama', 'facility': 'Medimetriks Investigational Site', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'overallOfficials': [{'name': 'Noah Rosenberg, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medimetriks Pharmaceuticals, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medimetriks Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}