Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-01 @ 1:19 PM
Study NCT ID:
NCT04566666
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-23
First Post:
2020-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-05', 'mcpReleaseN': 14, 'releaseDate': '2025-11-19'}], 'estimatedResultsFirstSubmitDate': '2025-11-19'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 263}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2020-09-25', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with at least 75% improvement in PASI (PASI 75)', 'timeFrame': 'Week16', 'description': 'The subjects showing at least 75% improvement in Psoriasis Area and Severity Index score on a scale of 0-4 score. Higher score denotes more severe disease activity.'}], 'secondaryOutcomes': [{'measure': "Investigator's Global Assessment (IGA) score", 'timeFrame': 'Week 16', 'description': "The subjects achieving predefined improvement (0 or 1) in Investigator's Global Assessment (IGA) of disease severity on a scale of 0 to 4 score. 0 indicates clear, while 1 indicates almost clear, while 4 is severe."}, {'measure': 'Change in Psoriasis Area and Severity Index (PASI) scores', 'timeFrame': 'Week 52', 'description': 'The subjects achieving predefined improvement in Psoriasis Area and Severity Index (PASI) on a scale of 0-4 score. Higher score denotes more severe disease activity..'}, {'measure': 'Psoriasis Area and Severity Index (PASI) response rate', 'timeFrame': 'Week 52', 'description': 'Psoriasis Area and Severity Index (PASI50, PASI75, PASI90, and PASI100) response rate at Week 12, 16, and 52'}, {'measure': 'Change in Psoriasis symptoms and signs diary (PSSD)', 'timeFrame': 'Week 52', 'description': 'At study week 0, 16, and 52; based on 11-item questionnaire, the symptoms and patient-observable signs in psoriasis will be scored using 0 to 10 rating scale.'}, {'measure': 'Change in Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Week 52', 'description': 'At study week 0, 16, and 52; based on 10-item questionnaire on skin problems (0 to 3 scale). The higher the score, the more quality of life is impaired.'}, {'measure': "Investigator's Global Assessment (IGA) score", 'timeFrame': 'Week 52', 'description': "The subjects achieving predefined improvement (0 or 1) in Investigator's Global Assessment (IGA) of disease severity on a scale of 0 to 4 score. 0 indicates clear, while 1 indicates almost clear, while 4 is severe."}, {'measure': 'Change in body surface area (BSA)', 'timeFrame': 'Week 52', 'description': 'At study weeks 0, 16, and 52, the Investigator will assess % BSA affected with psoriasis.'}, {'measure': 'Patient Global Impression of Severity (PGIS)', 'timeFrame': 'Week 52', 'description': 'At study weeks 0, 16, and 52, subjects will be asked to assess their overall impression of disease severity using a scale of None, Mild, Moderate or Severe.'}, {'measure': 'Patient Global Impression of Change (PGIC)', 'timeFrame': 'Week 52', 'description': "Subjects will be asked to assess if there has been a change in clinical status using a 5 point scale (1 to 5). 1 indicating 'Much better', while 5 indicating 'Much Worse'"}, {'measure': 'Evaluate pharmacokinetic parameter', 'timeFrame': 'Week 52', 'description': 'Steady-state maximum plasma concentration (Cmax-ss)'}, {'measure': 'Subjects with adverse events', 'timeFrame': 'Week 56', 'description': 'Monitoring (frequency, type, and severity) all the adverse events.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moderate to Severe Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with moderate to severe plaque psoriasis.', 'detailedDescription': 'This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to determine the effect of SCD-044 in subjects with moderate to severe plaque psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and non-pregnant non-lactating females with a diagnosis of predominantly plaque psoriasis for ≥ 6 months as determined by subject interview and confirmation of diagnosis through physical examination by Investigator.\n2. Aged at least 18 years.\n3. Subjects with no history of active TB or symptoms of TB\n\nExclusion Criteria:\n\n1. Subjects with non-plaque forms of psoriasis-like erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication exacerbated psoriasis or new-onset guttate psoriasis.\n2. Subjects who have anticipated the requirement of topical therapy, phototherapy, or systemic therapy for psoriasis during the trial.\n3. Subjects with history or presence of uveitis'}, 'identificationModule': {'nctId': 'NCT04566666', 'acronym': 'SOLARES-PsO-1', 'briefTitle': 'To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries Limited'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy And Safety of SCD-044 in the Treatment of Moderate to Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'SCD-044-19-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo of SCD-044 product', 'description': 'Placebo of SCD-044 study drug', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SCD-044 Tablets_Dose 1', 'description': 'SCD-044 tablets at Dose 1', 'interventionNames': ['Drug: SCD-044_Dose 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SCD-044 Tablets_Dose 2', 'description': 'SCD-044 tablets at Dose 2', 'interventionNames': ['Drug: SCD-044_Dose 2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SCD-044 Tablets_Dose 3', 'description': 'SCD-044 tablets at Dose 3', 'interventionNames': ['Drug: SCD-044_Dose 3']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo of SCD-044 product', 'armGroupLabels': ['Placebo of SCD-044 product']}, {'name': 'SCD-044_Dose 1', 'type': 'DRUG', 'description': 'SCD-044 tablets in Dose 1.', 'armGroupLabels': ['SCD-044 Tablets_Dose 1']}, {'name': 'SCD-044_Dose 2', 'type': 'DRUG', 'description': 'SCD-044 tablets in Dose 2', 'armGroupLabels': ['SCD-044 Tablets_Dose 2']}, {'name': 'SCD-044_Dose 3', 'type': 'DRUG', 'description': 'SCD-044 in Dose 3', 'armGroupLabels': ['SCD-044 Tablets_Dose 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85364', 'city': 'Yuma', 'state': 'Arizona', 'country': 'United States', 'facility': 'Yuma Clinical Trials, LLC', 'geoPoint': {'lat': 32.72532, 'lon': -114.6244}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'T. Joseph Raoof Md, Imc./Encino Research Center', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Metropolis Dermatology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Axis Clinical Trials', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91606', 'city': 'North Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 34.17223, 'lon': -118.37897}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Unison Clinical Trials', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '80109', 'city': 'Castle Rock', 'state': 'Colorado', 'country': 'United States', 'facility': 'Clarity Dermatology', 'geoPoint': {'lat': 39.37221, 'lon': -104.85609}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Accel Research Sites Network - Annexus Dermatology & Aestheitcs', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33484', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Beach Dermatology Group', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '33122', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'Revival Research Corporation', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'FXM Clinical Research Fort Lauderdale', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Direct Helpers Research Center', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33016', 'city': 'Hialeah Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Evolution Clinical Trials, Inc', 'geoPoint': {'lat': 25.8651, 'lon': -80.3245}}, {'zip': '33145', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'MedOne Clinical Research, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Century Research LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'FXM Clinical Research Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'JD Medical Group, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33027', 'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'FXM Clinical Research Miramar', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Adtremed Inc', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Clinical Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33615', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Alliance Clinical Research of Tampa', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30349', 'city': 'College Park', 'state': 'Georgia', 'country': 'United States', 'facility': 'Oracle Clinical Research', 'geoPoint': {'lat': 33.65344, 'lon': -84.44937}}, {'zip': '47906', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Physicians Research Group', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Revival research Institute, LLC', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '75234', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'DFW Clinical Research, LLC', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75149', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'SMS Clinical Research', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Stride Clinical Research', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '84663', 'city': 'Springville', 'state': 'Utah', 'country': 'United States', 'facility': 'Springville Dermatology/ CCT Research', 'geoPoint': {'lat': 40.16523, 'lon': -111.61075}}, {'zip': '22209', 'city': 'Arlington', 'state': 'Virginia', 'country': 'United States', 'facility': 'Skin DC Derm', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}, {'zip': 'CP 01501', 'city': 'La Libertad', 'country': 'El Salvador', 'facility': 'Clinica de Dermatologia y Cirugia de Piel', 'geoPoint': {'lat': 13.48833, 'lon': -89.32222}}, {'zip': 'CP 01101', 'city': 'San Salvador', 'country': 'El Salvador', 'facility': 'Clinica Dermatologica', 'geoPoint': {'lat': 13.68935, 'lon': -89.18718}}, {'zip': 'CP 01101', 'city': 'San Salvador', 'country': 'El Salvador', 'facility': 'Clinica Vargas', 'geoPoint': {'lat': 13.68935, 'lon': -89.18718}}, {'zip': '13419', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'North Estonia Medical Centre Foundation Ltd.', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '50106', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'Clinical Research Centre OU', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'zip': '101', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '112', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Israeli - Georgian Medical Research Clinic Helsikor LLC', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '144', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '159', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Emergency Cardiology Center by Academician G. Chapidze LLC', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '160', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'LTD Aversi Clinic', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '160', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'TIM - Tbilisi Institute of Medicine LLC', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '179', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'David Abuladze Georgian-Italian Clinic LLC', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '15879', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'ClinicMed', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '80-382', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Synexus Polska Sp. z o.o. Branch in Gdansk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '31-011', 'city': 'Krakow', 'country': 'Poland', 'facility': "Dobry Lekarz' Modern Therapies Center Limited Liability Company", 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-156', 'city': 'Krakow', 'country': 'Poland', 'facility': "Landa Specialist Doctor's Offices", 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '58-300', 'city': 'Kłodzko', 'country': 'Poland', 'facility': 'GLOBE Clinical Research', 'geoPoint': {'lat': 50.43488, 'lon': 16.66145}}, {'zip': '90-309', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Appletreeclinics Clinical Research Centre', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '60-309', 'city': 'Poznan', 'country': 'Poland', 'facility': 'EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '71-500', 'city': 'Szczecin', 'country': 'Poland', 'facility': 'TWOJA PRZYCHODNIA Medical Centre of Szczecin, Twoja Przychodnia SCM', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'zip': '02-507', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'National Medical Institute of the MSWiA, Clinical Department of Dermatology', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharmaceutical Industries Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}