Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2025-12-28 @ 6:04 PM
Study NCT ID:
NCT04169061
Status:
COMPLETED
Last Update Posted:
2021-08-18
First Post:
2019-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Acthar on Everyday Life of Participants With Severe Keratitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007634', 'term': 'Keratitis'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000324', 'term': 'Adrenocorticotropic Hormone'}], 'ancestors': [{'id': 'D053486', 'term': 'Melanocortins'}, {'id': 'D011333', 'term': 'Pro-Opiomelanocortin'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'MedInfo@mnk.com', 'phone': '800-844-2830', 'title': 'Medical Information Call Center', 'organization': 'Mallinckrodt'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'While participating in the trial (up to 22 weeks)', 'description': 'All serious adverse events that occurred during the trial are reported, regardless of dosing status. Non-serious treatment-emergent adverse events are included if 5% or more participants had that same event.\n\nParticipants may have more than one event per system organ class and preferred term.\n\nAt each level of subject summarization, a participant is counted once if the participant had one or more events.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'Participants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 2, 'seriousNumAtRisk': 36, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'A 12-point score reduction on the 100-point symptom bother module indicates a clinically important reduction of bothersome dry eye symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with non-missing baseline data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'Participants receive:\n\n* a shot of Acthar (80 units) under the skin twice a week for 12 weeks\n* a shot of Acthar (40 units) twice a week for 2 weeks\n* a shot of Acthar (40 units) once a week for 2 more weeks\n\nAt each visit they will have medical tests and answer questions about their symptoms.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'Modified Intent to Treat (mITT) Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Thirty-six participants were enrolled at 8 locations in the United States'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Participants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'spread': '10.17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', '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': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Analysis Population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-11', 'size': 806725, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-27T14:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-27', 'studyFirstSubmitDate': '2019-11-14', 'resultsFirstSubmitDate': '2021-07-07', 'studyFirstSubmitQcDate': '2019-11-18', 'lastUpdatePostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-27', 'studyFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12]', 'timeFrame': 'Week 12', 'description': 'A 12-point score reduction on the 100-point symptom bother module indicates a clinically important reduction of bothersome dry eye symptoms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Severe or recalcitrant keratitis'], 'conditions': ['Keratitis']}, 'referencesModule': {'references': [{'pmid': '34669183', 'type': 'DERIVED', 'citation': 'Wirta D, McLaurin E, Ousler G, Liu J, Kacmaz RO, Grieco J. Repository Corticotropin Injection (Acthar(R) Gel) for Refractory Severe Noninfectious Keratitis: Efficacy and Safety from a Phase 4, Multicenter, Open-Label Study. Ophthalmol Ther. 2021 Dec;10(4):1077-1092. doi: 10.1007/s40123-021-00400-y. Epub 2021 Oct 20.'}]}, 'descriptionModule': {'briefSummary': 'We will need about 36 participants for this study.\n\nVolunteers might be able to participate if:\n\n* they have bad noninfectious keratitis\n* early treatments failed or were not well tolerated\n\nParticipants will be in the study for about 22 weeks:\n\n* 4 weeks for tests to see if the study might be good for them\n* 12 weeks of treatment with Acthar gel\n* 4 weeks to wean off Acthar gel and follow-up with the doctor'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has severe or recalcitrant keratitis\n* Did not respond to, or tolerate, treatment with topical cyclosporine, Lifitegrast, or any immunosuppressant to treat keratitis\n* If able to reproduce, agrees to use 2 forms of effective contraception with a partner of the opposite sex for the duration of the study (through Visit 6)\n* Has normal eyelids, and protocol-defined physical and medical eye attributes\n* Agrees to avoid wearing contact lenses during the trial\n\nExclusion Criteria:\n\n* Is pregnant or breast-feeding\n* Is defined as vulnerable, or is employed by, or related to anyone involved in the study\n* Has a medical condition or history that might, per protocol or in the opinion of the investigator, compromise the participant's safety or study analysis"}, 'identificationModule': {'nctId': 'NCT04169061', 'briefTitle': 'Impact of Acthar on Everyday Life of Participants With Severe Keratitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mallinckrodt'}, 'officialTitle': 'A Multicenter, Open-label Study to Assess the Efficacy and Safety of Acthar® Gel in Subjects With Severe Keratitis', 'orgStudyIdInfo': {'id': 'MNK14084113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All participants', 'description': 'Participants receive:\n\n* a shot of Acthar (80 units) under the skin twice a week for 12 weeks\n* a shot of Acthar (40 units) twice a week for 2 weeks\n* a shot of Acthar (40 units) once a week for 2 more weeks\n\nAt each visit they will have medical tests and answer questions about their symptoms.', 'interventionNames': ['Drug: Acthar']}], 'interventions': [{'name': 'Acthar', 'type': 'DRUG', 'otherNames': ['Acthar Gel'], 'description': 'Acthar gel for subcutaneous injection', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cornea and Cataract Consultants of Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Global Research Management, Inc.', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Eye Research Foundation', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '40206', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Eye Care Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02767', 'city': 'Raynham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 41.94871, 'lon': -71.0731}}, {'zip': '28150', 'city': 'Shelby', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Vita Eye Clinic', 'geoPoint': {'lat': 35.29235, 'lon': -81.53565}}, {'zip': '06066', 'city': 'Cranberry Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Scott & Christie and Associates, PC', 'geoPoint': {'lat': 40.68496, 'lon': -80.10714}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Total Eye Care, P.A.', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Advancing Vision Research, LLC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Global Clinical Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mallinckrodt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT04169061) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mallinckrodt', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}