Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT06032858
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2023-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Apremilast in Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C505730', 'term': 'apremilast'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-05', 'studyFirstSubmitDate': '2023-09-05', 'studyFirstSubmitQcDate': '2023-09-05', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psoriasis area and severity index', 'timeFrame': '16 weeks'}, {'measure': 'body surface area', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'referencesModule': {'references': [{'pmid': '22257911', 'type': 'BACKGROUND', 'citation': 'Schafer P. Apremilast mechanism of action and application to psoriasis and psoriatic arthritis. Biochem Pharmacol. 2012 Jun 15;83(12):1583-90. doi: 10.1016/j.bcp.2012.01.001. Epub 2012 Jan 10.'}, {'pmid': '28416342', 'type': 'BACKGROUND', 'citation': 'Crowley J, Thaci D, Joly P, Peris K, Papp KA, Goncalves J, Day RM, Chen R, Shah K, Ferrandiz C, Cather JC. Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for >/=156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2). J Am Acad Dermatol. 2017 Aug;77(2):310-317.e1. doi: 10.1016/j.jaad.2017.01.052. Epub 2017 Apr 14.'}]}, 'descriptionModule': {'briefSummary': "Psoriasis is a long standing inflammatory, autoinflammatory disease linked with many comorbidities. Patients with moderate to severe plaque psoriasis can be managed with topical as well as systemic medications. FDA approved Apremilast as first drug to be taken orally in cases of psoriasis in mid 1990's. Currently, according to researchers best knowledge no study has been done on use of Apremilast in Pakistan. It has recently become available here. Keeping in view all the benefits of this drug, a study has been planned to check its effectiveness and safety 30mg twice a day, in patients with moderate to severe chronic plaque psoriasis based on Psoriasis area and severity index and Body surface area assessments in our population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed patients of chronic plaque psoriasis\n* patients applicant for oral or parenteral treatments and for light therapy\n* patients not responding to topical treatments\n\nExclusion Criteria:\n\n* Patients who show hypersensitive reactions to apremilast to any of its inactive component\n* Pregnancy\n* Lactating mothers'}, 'identificationModule': {'nctId': 'NCT06032858', 'briefTitle': 'Efficacy and Safety of Apremilast in Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'Ghurki Trust and Teaching Hospital'}, 'officialTitle': 'Efficacy and Safety of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'D6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apremilast 30 mg twice daily', 'interventionNames': ['Drug: Apremilast 30mg']}], 'interventions': [{'name': 'Apremilast 30mg', 'type': 'DRUG', 'description': 'Apremilast 30mg twice daily', 'armGroupLabels': ['Apremilast 30 mg twice daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Ghurki Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Prof. Dr. Haroon Nabi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor Department of Dermatology LMDC'}, {'name': 'Dr. Saira Muaaz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology Ghurki Hospital'}, {'name': 'Dr. Hira Tariq', 'role': 'STUDY_CHAIR', 'affiliation': 'Senior Registrar Department of Dermatology Services Hospital'}, {'name': 'Dr. Sumera Hanif', 'role': 'STUDY_CHAIR', 'affiliation': 'Senior Registrar Department of Dermatology LMDC'}, {'name': 'Dr. Talat Akbar', 'role': 'STUDY_CHAIR', 'affiliation': 'Associate Professor, Dermatology, LMDC'}, {'name': 'Prof. Dr. Faria Asad', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of Department Dermatology SIMS/ Services Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ghurki Trust and Teaching Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}