Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-25 @ 7:26 PM
Study NCT ID:
NCT02982005
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2016-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of KHK4827 (Brodalumab) in Subjects With Moderate to Severe Psoriasis in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C571216', 'term': 'brodalumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2016-12-01', 'studyFirstSubmitQcDate': '2016-12-02', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psoriasis area and severity index (PASI) 75 response', 'timeFrame': 'at week 12'}, {'measure': 'Static physician\'s global assessment (sPGA) of "0 (clear)" or "1 (almost clear)"', 'timeFrame': 'at week 12'}], 'secondaryOutcomes': [{'measure': 'PASI 50/75/90/100 response by visit', 'timeFrame': 'Baseline to week 64'}, {'measure': 'sPGA of "0 (clear) or 1 (almost clear)" by visit', 'timeFrame': 'Baseline to week 64'}, {'measure': 'Body surface area (BSA) involvement of lesion', 'timeFrame': 'Baseline to week 64'}, {'measure': 'Nail psoriasis severity index (NAPSI) score (applicable only to subjects who had nail symptoms at baseline)', 'timeFrame': 'Baseline to week 64'}, {'measure': 'Psoriasis scalp severity index (PSSI) score (applicable only to subjects who had scalp symptoms at baseline)', 'timeFrame': 'Baseline to week 64'}, {'measure': 'Dermatology life quality index (DLQI)', 'timeFrame': 'Baseline to week 64'}, {'measure': 'Treatment-emergent adverse events (TEAEs) or drug-related TEAEs', 'timeFrame': 'Baseline to week 64'}, {'measure': 'Laboratory values', 'timeFrame': 'Baseline to week 64'}, {'measure': 'Vital signs', 'timeFrame': 'Baseline to week 64'}, {'measure': 'Anti-KHK4827 antibodies', 'timeFrame': 'Baseline, Week 12, Week 24, Week 48, Week 64'}, {'measure': 'Serum KHK4827 concentration', 'timeFrame': 'Baseline, Week 8, Week 10, Week 12, Week 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['KHK4827 (brodalumab)'], 'conditions': ['Moderate to Severe Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the efficacy and safety of KHK4827 in subjects with moderate to severe plaque psoriasis randomized in a double-blind manner to receive KHK4827 or placebo for 12 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has had stable moderate to severe plaque psoriasis for at least 6 months\n* Subject has involved BSA ≧ 10%, PASI ≧ 12, and sPGA ≧ 3 at screening and at baseline\n\nExclusion Criteria:\n\n* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, or a medication-induced psoriasis, or other skin conditions (e.g., eczema) at screening that would interfere with study evaluations\n* Subject scheduled to undergo a surgical intervention during the study period\n* Subject has any active infection or history of infections as defined in the study protocol\n* Subject has known history of Crohn\'s disease\n* Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol\n* Subject has not stopped using certain psoriasis therapies as defined in the study protocol\n* Subject has previously used any anti-IL-17 biologic therapy\n* Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study\n* Women of child-bearing potential or fertile men who do not agree to use effective contraception from the day of providing consent through 12 weeks after the last dose of investigational product.\n* Subject has known 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 screening or at baseline\n* Subject has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at screening or at baseline\n* Subject has known history or evidence of a psychiatric disorder that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion\n* Subject has known history of alcohol and/or substance abuse within the last 12 months"'}, 'identificationModule': {'nctId': 'NCT02982005', 'briefTitle': 'A Study of KHK4827 (Brodalumab) in Subjects With Moderate to Severe Psoriasis in Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of KHK4827 in Subjects With Moderate to Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': '4827-KR001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KHK4827', 'description': 'KHK4827 administered SC', 'interventionNames': ['Drug: KHK4827']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered SC', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'KHK4827', 'type': 'DRUG', 'otherNames': ['Brodalumab'], 'description': 'Administered KHK4827 by subcutaneous (SC) injection until week 62.', 'armGroupLabels': ['KHK4827']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered placebo by subcutaneous (SC) injection until week 12. Administered KHK4827 by SC injection from week 13 until week 62.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49241', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea, Republic of', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Korea Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}