Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT01698333
Status:
COMPLETED
Last Update Posted:
2018-10-24
First Post:
2012-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicalresearch@therapeuticsinc.com', 'phone': '858-571-1800', 'title': 'Clinical Research', 'organization': 'Therapeutics Inc.'}, 'certainAgreement': {'otherDetails': 'The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 12 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 30 days prior to public dissemination. The PI may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected from study screening (performed 20 days or more prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.', 'description': 'The Safety population included all subjects enrolled in the study who were dispensed the test article at least once. Each subject counted once for each AE Term.', 'eventGroups': [{'id': 'EG000', 'title': '122-0551', 'description': '122-0551: Applied twice daily for 2 weeks', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 8, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Procedural Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'ACTH Stimulation Test Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hypothalamic-Pituitary-Adrenal (HPA) Axis Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '122-0551', 'description': '122-0551: Applied twice daily for 2 weeks'}], 'classes': [{'categories': [{'title': 'Normal', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Abnormal', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 15', 'description': 'HPA axis response to stimulation by cosyntropin, dichotomized to "normal" and "abnormal". Laboratory evidence of abnormal HPA axis response is defined as a 30-minute post-stimulation serum cortisol level that is ≤ 18 μg/dL at the end of study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis shown is based on the ITT population, defined as all enrolled participants who applied at least one dose of the test article and returned for at least one post-Baseline visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '122-0551', 'description': '122-0551: Applied twice daily for 2 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment period: April 2012 to March 2013\n\nThe location of clinical sites included private dermatology clinics and clinical research centers.', 'preAssignmentDetails': 'All subjects who met the entry criteria were enrolled into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '122-0551', 'description': '122-0551: Applied twice daily for 2 weeks'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.7', 'spread': '11.64', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent-To-Treat (ITT) population included all participants enrolled in the study who were dispensed and applied test article at least once and had at least one follow-up visit after the Baseline visit (Visit 2). All 25 enrolled subjects were included in the ITT population.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'dispFirstSubmitDate': '2013-11-25', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-28', 'studyFirstSubmitDate': '2012-09-27', 'dispFirstSubmitQcDate': '2013-11-25', 'resultsFirstSubmitDate': '2018-08-30', 'studyFirstSubmitQcDate': '2012-09-28', 'dispFirstPostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-30', 'studyFirstPostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypothalamic-Pituitary-Adrenal (HPA) Axis Response', 'timeFrame': 'Day 15', 'description': 'HPA axis response to stimulation by cosyntropin, dichotomized to "normal" and "abnormal". Laboratory evidence of abnormal HPA axis response is defined as a 30-minute post-stimulation serum cortisol level that is ≤ 18 μg/dL at the end of study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['122-0551', 'steroid', 'HPA'], 'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is designed to determine the adrenal effects of the investigational formulation of 122-0551 and characterize the steady state pharmacokinetics of the formulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has a clinical diagnosis of stable plaque psoriasis\n\nExclusion Criteria:\n\n* Subject has spontaneously improving or rapidly deteriorating plaque psoriasis\n* Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis\n* Subject has used any phototherapy, photo-chemotherapy or systemic psoriasis therapy within 30 days prior to initiation of treatment\n* Subject has used systemic corticosteroids or topical, inhaled, intranasal corticosteroids within 30 days and 14 days, respectively, prior to study screening\n* Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to initiation of treatment\n* Subject has used topical psoriatic therapy including tar, anthralin, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to initiation of treatment\n* Subject has used emollients/moisturizers on areas to be treated within one day prior to initiation of treatment\n* Subject is currently using lithium or Plaquenil (hydroxychloroquine)\n* Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ACE) inhibitors (e.g., lisinopril) at a dose that has not been stabilized\n* Subject is pregnant, nursing or planning a pregnancy during the study period\n* Subject is currently enrolled in an investigational drug, biologic or device study\n* Subject has received an investigational drug, biologic or an investigational device within 30 days prior to study start\n* Subject has been previously enrolled in this study and treated with the test article\n* Subject has an irregular sleep schedule or works night shifts'}, 'identificationModule': {'nctId': 'NCT01698333', 'briefTitle': 'Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Therapeutics, Inc.'}, 'officialTitle': 'An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Twice Daily 122-0551 in Subjects With Plaque Psoriasis Receiving Two Weeks of Treatment', 'orgStudyIdInfo': {'id': '122-0551-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '122-0551', 'interventionNames': ['Drug: 122-0551']}], 'interventions': [{'name': '122-0551', 'type': 'DRUG', 'description': 'Applied twice daily for 2 weeks', 'armGroupLabels': ['122-0551']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Therapeutics Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'DermResearch, Inc.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Syd Dromgoole, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}