Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT04911751
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2021-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-05', 'studyFirstSubmitDate': '2021-05-09', 'studyFirstSubmitQcDate': '2021-05-27', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psoriasis Area and Severity Index (PASI)', 'timeFrame': 'Baseline to Week 12', 'description': 'Change from Baseline in PASI score'}], 'secondaryOutcomes': [{'measure': 'Psoriasis Area and Severity Index (PASI)', 'timeFrame': 'Baseline to Weeks 2, 4 and 8', 'description': 'Change from Baseline in PASI score'}, {'measure': 'Psoriasis Area and Severity Index (PASI) -50', 'timeFrame': 'Baseline to Week 12', 'description': 'Percent of patients who achieved PASI-50'}, {'measure': 'Psoriasis Area and Severity Index (PASI) -75', 'timeFrame': 'Baseline to Week 12', 'description': 'Percent of patients who achieved PASI-75'}, {'measure': "Physician's Global Assessment (PGA)", 'timeFrame': 'Baseline to Weeks 4, 8 and 12', 'description': 'Change from Baseline in PGA score'}, {'measure': "Physician's Global Assessment (PGA)", 'timeFrame': 'Week 12', 'description': 'Percent of patients who achieve PGA score of 0 or 1'}, {'measure': 'Psoriasis-Affected Body Surface Area (BSA)', 'timeFrame': 'Baseline to Weeks 4, 8 and 12', 'description': 'Change from Baseline in Psoriasis-Affected BSA'}, {'measure': 'Safety measure through incidence of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Baseline to Week 16', 'description': 'The number of patients experiencing TEAEs and number of individual TEAEs will be summarized among treatment arms, by system organ class (SOC) and PT. TEAEs will also be summarized among treatment arms, by severity and by relationship to study drug.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microbiome', 'KBL697', 'Plaque psoriasis'], 'conditions': ['Psoriatic Plaque']}, 'descriptionModule': {'briefSummary': 'The study is designed to investigate efficacy and safety of KBL697 in patients with Moderate Plaque Type Psoriasis. KBL697 has been developed as a potential new treatment for Psoriatic Plaque.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged 18 to 75 years (inclusive)\n* Have a diagnosis of plaque type psoriasis for ≥ 6 months\n* Must have chronic plaque type psoriasis of moderate severity\n* All subjects must agree and commit to the use of a reliable contraceptive regimen.\n\nExclusion Criteria:\n\n* Current diagnosis of forms of psoriasis other than chronic plaque type only\n* Drug-induced psoriasis\n* Other inflammatory skin disease that may confound the evaluation of plaque psoriasis\n* Failed 2 or more systemic treatments for plaque psoriasis\n* Medicinal shampoos that contain tar and/or salicylic acid within 2 weeks prior to Baseline Visit'}, 'identificationModule': {'nctId': 'NCT04911751', 'briefTitle': 'A Study to Investigate Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'KoBioLabs'}, 'officialTitle': 'A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of KBL697 in Patients with Moderate Plaque Type Psoriasis', 'orgStudyIdInfo': {'id': 'KBL-CURE-2020-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low dose group', 'description': '39 subjects for low dose group. 26 subjects on KBL697, 13 subjects on placebo.', 'interventionNames': ['Drug: KBL697']}, {'type': 'EXPERIMENTAL', 'label': 'High dose group', 'description': '39 subjects for high dose group. 26 subjects on KBL697, 13 subjects on placebo.', 'interventionNames': ['Drug: KBL697']}], 'interventions': [{'name': 'KBL697', 'type': 'DRUG', 'description': '1 capsule BID of KBL697 or Placebo', 'armGroupLabels': ['Low dose group']}, {'name': 'KBL697', 'type': 'DRUG', 'description': '5 capsules BID of KBL697 or Placebo', 'armGroupLabels': ['High dose group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Total Skin and Beauty Dermatology Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92701', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Dermatology, Inc', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Science Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33122', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'Revival Research Institute', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Indago Research and Health Center', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana Dermatology Associates - Dermatology', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Premier Specialist', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Veracity Clinical Trials Ltd', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Sinclair Dermatology', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}], 'overallOfficials': [{'name': 'Ira Thorla', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Louisiana Dermatology Associates'}, {'name': 'Jose Cardona', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indago Research and Health Center'}, {'name': 'Jennifer Soung', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern California Dermatology, Inc'}, {'name': 'James Krell', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Total Skin and Beauty Dermatology Center'}, {'name': 'Paul Yamauchi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Science Institute'}, {'name': 'Ivette Espinosa-Fernandez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Revival Research Institute'}, {'name': 'Annika Smith', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Westmead Hospital'}, {'name': 'Deirdre Murrell', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Premier Specialist'}, {'name': 'Lynda Spelman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Veracity Clinical Trials Ltd'}, {'name': 'Samantha Eisman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sinclair Dermatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KoBioLabs', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}