Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-29 @ 4:04 PM
Study NCT ID:
NCT04368403
Status:
COMPLETED
Last Update Posted:
2025-07-11
First Post:
2020-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of KHK4827 in Patients With Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571216', 'term': 'brodalumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2020-04-13', 'studyFirstSubmitQcDate': '2020-04-28', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum KHK4827 concentration', 'timeFrame': 'Pre-dose, Week 1, 2, 4, 8, 12, 16, 22, 24, 36, 48, 52 and every 24 weeks through study completion until 2025.'}], 'secondaryOutcomes': [{'measure': 'Change in modified Rodnan skin score (mRSS) from baseline', 'timeFrame': 'Pre-dose, Week 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and every 8 weeks through study completion until 2025.', 'description': 'mRSS: scored 0(normal), 1(mild), 2(moderate), or 3(severe) per each site, assessed in 17 different body sites, total score=51'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['systemic sclerosis', 'brodalumab', 'KHK4827'], 'conditions': ['Systemic Sclerosis']}, 'referencesModule': {'references': [{'pmid': '36997069', 'type': 'DERIVED', 'citation': 'Fukasawa T, Yoshizaki A, Ebata S, Fukayama M, Kuzumi A, Norimatsu Y, Matsuda KM, Kotani H, Sumida H, Yoshizaki-Ogawa A, Kagebayashi H, Sato S. Interleukin-17 pathway inhibition with brodalumab in early systemic sclerosis: Analysis of a single-arm, open-label, phase 1 trial. J Am Acad Dermatol. 2023 Aug;89(2):366-369. doi: 10.1016/j.jaad.2023.02.061. Epub 2023 Mar 29. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Exploratory evaluation of pharmacokinetics and safety of KHK4827 in subjects with systemic sclerosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject meets the criteria for diagnosis of the Diagnostic Criteria, Severity Classification, and Clinical Practice Guidelines for Systemic Sclerosis （Japanese Dermatological Association 2016） at the pre-examination\n* Subject presented the first symptoms of sclerosis other than Raynaud's phenomenon within 60 months before enrollment\n* Subject who has systemic sclerosis accompanied by moderate to severe skin thickening with an mRSS of 10 to \\<30 at the pre-examination and who has progressing skin thickening\n\nExclusion Criteria:\n\n1. Any of the following significant concomitant diseases:\n\n * Type 1 diabetes\n * Poorly controlled type 2 diabetes (HbA1c \\> 8.5%)\n * Congestive heart failure (Class II to IV of the New York Heart Association Functional Classification)\n * Myocardial infarction, unstable angina, or stroke occurring within 12 months before the first dose of investigational product\n * Poorly controlled hypertension (systolic pressure \\> 150 mm Hg or diastolic pressure \\> 90 mg Hg at screening)\n * Severe chronic lung disease (%Forced Vital Capacity (FVC) \\< 60% and %Diffusing capacity of lung for carbon monoxide (DLco) \\< 40%, calculated according to the Reference Values for Spirometry, Including Viral Capacity, in Japanese Adults Calculated with the LMS Method and Compared with Previous Values \\[Japanese Respiratory Society\\])\n * Major chronic inflammatory diseases or connective tissue diseases other than scleroderma\n2. Patient has a history or evidence of a psychiatric disorder, alcohol and/or substance abuse, or any other mental health disorder that, in the opinion of the investigators, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion\n3. Patient has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at enrollment\n4. Patient has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment"}, 'identificationModule': {'nctId': 'NCT04368403', 'briefTitle': 'A Study of KHK4827 in Patients With Systemic Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'A Phase 1, Open-label, Multiple-dose Study of KHK4827 in Subjects With Systemic Sclerosis', 'orgStudyIdInfo': {'id': '4827-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KHK4827', 'interventionNames': ['Drug: KHK4827']}], 'interventions': [{'name': 'KHK4827', 'type': 'DRUG', 'description': '210 mg every 2 weeks (Q2W), subcutaneous (SC) injection', 'armGroupLabels': ['KHK4827']}]}, 'contactsLocationsModule': {'locations': [{'zip': '113-8655', 'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'The University of Tokyo Hospital'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/kyowa-kirin/', 'ipdSharing': 'YES', 'description': 'There is a plan to make IPD and related data dictionaries available. The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}