Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-29 @ 9:02 AM
Study NCT ID:
NCT06338358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding Participation Habits Among Plaque Psoriasis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-22', 'size': 67831, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-22T09:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-22', 'studyFirstSubmitDate': '2024-03-22', 'studyFirstSubmitQcDate': '2024-03-22', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients who decide to enroll in a plaque psoriasis clinical research.', 'timeFrame': '3 months'}, {'measure': 'Number of plaque psoriasis study participants who remain in clinical study until completion.', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Plaque Psoriasis'], 'conditions': ['Plaque Psoriasis']}, 'referencesModule': {'references': [{'pmid': '35820547', 'type': 'BACKGROUND', 'citation': 'Armstrong AW, Gooderham M, Warren RB, Papp KA, Strober B, Thaci D, Morita A, Szepietowski JC, Imafuku S, Colston E, Throup J, Kundu S, Schoenfeld S, Linaberry M, Banerjee S, Blauvelt A. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. J Am Acad Dermatol. 2023 Jan;88(1):29-39. doi: 10.1016/j.jaad.2022.07.002. Epub 2022 Jul 9.'}, {'pmid': '32022825', 'type': 'BACKGROUND', 'citation': 'Armstrong AW, Puig L, Joshi A, Skup M, Williams D, Li J, Betts KA, Augustin M. Comparison of Biologics and Oral Treatments for Plaque Psoriasis: A Meta-analysis. JAMA Dermatol. 2020 Mar 1;156(3):258-269. doi: 10.1001/jamadermatol.2019.4029.'}, {'pmid': '35544084', 'type': 'BACKGROUND', 'citation': 'Gordon KB, Langley RG, Warren RB, Okubo Y, Stein Gold L, Merola JF, Peterson L, Wixted K, Cross N, Deherder D, Thaci D. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2022 Jul 1;158(7):735-744. doi: 10.1001/jamadermatol.2022.1185.'}]}, 'descriptionModule': {'briefSummary': "The study intends to investigate the personal experiences of plaque psoriasis patients who take part in a separate clinical study including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal.\n\nThe data collected from this study will help improve future outcomes for all plaque psoriasis as well as those in under-represented demographic groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with plaque psoriasis who are actively considering enrolling in a clinical trial for said condition, but have not yet completed enrollment and randomization phases.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with plaque psoriasis\n* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed\n* Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.\n\nExclusion Criteria:\n\n* Refusal of consent\n* Women of childbearing potential without a negative pregnancy test; or women who are lactating.\n* Any serious and/or unstable pre-existing medical disorders'}, 'identificationModule': {'nctId': 'NCT06338358', 'briefTitle': 'Understanding Participation Habits Among Plaque Psoriasis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': "In the Patient's Words: Understanding Patient Participation and Engagement in Plaque Psoriasis Clinical Trials", 'orgStudyIdInfo': {'id': '44519568'}}, 'contactsLocationsModule': {'locations': [{'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'https://www.withpower.com/contact-us@withpower.com', 'phone': '415-900-4227'}], 'facility': 'Power Life Sciences', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'bask@withpower.com', 'phone': '(415) 900-4227'}], 'overallOfficials': [{'name': 'Michael B Gill', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Power Life Sciences Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Power Life Sciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}