Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-01-02 @ 5:40 AM
Study NCT ID:
NCT04858659
Status:
UNKNOWN
Last Update Posted:
2021-09-22
First Post:
2021-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 3 Study to Assess the Efficacy and Safety of PK101 in Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 354}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-15', 'studyFirstSubmitDate': '2021-04-05', 'studyFirstSubmitQcDate': '2021-04-21', 'lastUpdatePostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change during activity in 100mm Pain VAS', 'timeFrame': 'baseline through week 8', 'description': 'Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever'}], 'secondaryOutcomes': [{'measure': 'Change during activity in 100mm Pain VAS', 'timeFrame': 'baseline through week 4', 'description': 'Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever'}, {'measure': 'Change at rest in 100mm Pain VAS', 'timeFrame': 'baseline through week 4, 8', 'description': 'Visual Analogue Scale, 0 mm no pain, 100 mm worst pain ever'}, {'measure': 'Change in WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index using the Visual Analogue Scale, Version 3.1) sub scale & total score', 'timeFrame': 'baseline through week 4, 8', 'description': 'Assessment of pain, stiffness and physical function. Score range 0-500 mm for Pain, 0-200 mm for Stiffness, and 0-1700 mm for Physical Function. Higher scores indicate worse pain, stiffness, and functional limitations.'}, {'measure': 'Change in PGA', 'timeFrame': 'baseline through week 8', 'description': "PGA for disease severity (Patient's Global Assessment, 1=Very good, 2=Good, 3=Fair, 4=Poor, 5=Very Poor)"}, {'measure': 'Change in SF-36 sub scale & PCS, MCS as measured by Health Survey(Short Form, SF-36 v2, Physical Component Summary, Mental Component Summary)', 'timeFrame': 'baseline through week 8', 'description': "The SF-36 v2 is a 36-item, patient-reported survey of patient's health, consisting of 2 components(the PCS and the MCS) included 8 subscales.\n\nPatients rated their QoL using a 2-6 point Likert Scale. Score is converting the original score to 0\\~100 points.\n\nThe lower score means poor health status, and the higher score, the better."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy and the safety of PK101 in patients with knee osteoarthritis.', 'detailedDescription': 'The primary purpose of this study is to evaluate the efficacy of PK101 compared with PK101-002 at Week 8 in osteoarthritis. Also evaluates the safety of PK101.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥40 and of age\n* Patients who meets the American College Rheumatology (ACR) criteria and has lasted for at least three months after diagnosis of one-sided or bilateral knee osteoarthritis.\n* Radiographic evidence of grade 1 \\~ 3 osteoarthritis based on the Kellgren \\& Lawrence radiographic entry criteria at visit 1\n* Score of 100mm pain VAS ≤ 80mm at visit 1\n* Written consent form voluntarily\n* Score of 100mm pain VAS ≥ 40mm at visit 3\n* Patients with an individual medication compliance of 70% or more of the IP administered during the Run-in period\n\nExclusion Criteria:\n\n* Patients who has a history of hypersensitivity to components of IP, NSAIDs including COX-2 inhibitors, a history of hypersensitivity to aspirin, or allergic reactions to sulfonamides\n* Patients with inflammatory, infectious, metabolic, septic arthritis or rheumatoid arthritis other than osteoarthritis\n* Patients with a condition that can affect the joints\n* Patients who have undergone arthroscopic surgery within 1 year , knee joint surgery within 5 years, synoviorthesis within 3 months prior to visit 1 to the target knee, or who have planned surgery during the trial period\n* Patients who have used corticosteroids as follows:\n\n * Inj. of corticosteroid, including intraarticular administration, into the target knee within 3 months prior to visit 1\n * Oral corticosteroid administration within 1 month prior to visit 1\n* Patients who have intraarticular injected hyaluronic acid or cell therapy products, gene therapy products, etc. for the treatment of osteoarthritis within 3 months prior to visit 1'}, 'identificationModule': {'nctId': 'NCT04858659', 'briefTitle': 'A Phase 3 Study to Assess the Efficacy and Safety of PK101 in Patients With Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'PMG Pharm Co., Ltd'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-designed, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of PK101 Compared With PK101-002 in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'PK101_P301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PK101 group', 'interventionNames': ['Drug: PK101', 'Drug: PK101-002 placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PK101-002 group', 'interventionNames': ['Drug: PK101-002', 'Drug: PK101 placebo']}], 'interventions': [{'name': 'PK101', 'type': 'DRUG', 'description': '1 tablet at each time, 2 times a day', 'armGroupLabels': ['PK101 group']}, {'name': 'PK101-002', 'type': 'DRUG', 'description': '1 tablet at each time, 2 times a day', 'armGroupLabels': ['PK101-002 group']}, {'name': 'PK101 placebo', 'type': 'DRUG', 'description': '1 tablet at each time, 2 times a day', 'armGroupLabels': ['PK101-002 group']}, {'name': 'PK101-002 placebo', 'type': 'DRUG', 'description': '1 tablet at each time, 2 times a day', 'armGroupLabels': ['PK101 group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54907', 'city': 'Jeonju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Wan-Hee Yoo', 'role': 'CONTACT', 'email': 'ywhim@chonbuk.ac.kr', 'phone': '82-63-250-2377'}], 'facility': 'Jeonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PMG Pharm Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}