Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT06696716
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2024-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ONO-4059 Study in Patients With Steroid-resistant Pemphigus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010392', 'term': 'Pemphigus'}], 'ancestors': [{'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000608238', 'term': 'tirabrutinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2024-11-07', 'studyFirstSubmitQcDate': '2024-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients with a Complete response (CR) or Partial response (PR) at 52 weeks, and maintaining complete/partial remission at 52 weeks from initial remission achievement.', 'timeFrame': '52 weeks', 'description': 'CR: Absence of pemphigus-related blisters or new erythema that lasts for 8 weeks during treatment with ONO-4059 plus an oral corticosteroid (≤10 mg/day prednisolone-equivalent) or minimal adjunctive therapy.\n\nPR: Occurrence of only a transient lesion that resolves within 1 week without an increased dose of an oral corticosteroids, without treatment, or with a topical corticosteroid, etc., during treatment with ONO-4059 plus an oral corticosteroid (≤10 mg/day prednisolone-equivalent) or minimal adjunctive therapy for 8 weeks.'}], 'secondaryOutcomes': [{'measure': 'Remission rate', 'timeFrame': '52 weeks', 'description': 'remission rate \\[proportion of subjects who achieve complete or partial remission\\], complete remission rate, partial remission rate'}, {'measure': 'Pemphigus Disease Area Index (PDAI) score', 'timeFrame': '52 weeks', 'description': 'Pemphigus Disease Area Index (PDAI). PDAI activity score cutoffs were defined as 0 to 8 for mild, 9 to 24 for moderate, and 25 or higher for severe disease.'}, {'measure': 'Efficacy 1 rate (proportion of subjects for whom the definition of efficacy 1 is applicable)', 'timeFrame': '52 weeks', 'description': 'Definition of efficacy 1: Decreases in PDAI score and oral corticosteroid dose from baseline'}, {'measure': 'Efficacy 2 rate (proportion of subjects for whom the definition of efficacy 2 is applicable)', 'timeFrame': '52 weeks', 'description': 'Definition of efficacy 2: PDAI score is 0 and oral corticosteroid dose \\<= 10 mg/day'}, {'measure': 'Disease control rate (proportion of subjects for whom the definition of disease control is applicable)', 'timeFrame': '52 weeks', 'description': 'Definition of disease control: Formation of nascent lesions stops and existing lesions begin to resolve'}, {'measure': 'Rescue therapy rate', 'timeFrame': '52 weeks', 'description': 'Proportion of subjects who received rescue therapy'}, {'measure': 'Pemphigus autoantibody titer', 'timeFrame': '52 weeks', 'description': 'Anti-desmoglein 1 antibodies, anti-desmoglein 3 antibodies'}, {'measure': 'Oral corticosteroid dose', 'timeFrame': '52 weeks', 'description': 'At the equivalent dose of prednisolone'}, {'measure': 'QOL evaluation', 'timeFrame': '52 weeks', 'description': 'The Dermatology Life Quality Index (DLQI) score is measured by questionnaire.'}, {'measure': 'Adverse events and adverse drug reactions', 'timeFrame': '52 weeks'}, {'measure': 'Clinical laboratory tests', 'timeFrame': '52 weeks', 'description': 'Number of participants with clinical laboratory abnormalities (including haematology, clinical chemistry and urinalysis).'}, {'measure': '12-lead ECG', 'timeFrame': '52 weeks', 'description': 'Heart rate, RR interval, PR interval, QRS duration, QT interval and QTcF'}, {'measure': 'Vital signs', 'timeFrame': '52 weeks', 'description': 'Systolic/diastolic blood pressure'}, {'measure': 'Vital signs', 'timeFrame': '52 weeks', 'description': 'Body temperature'}, {'measure': 'Immunological tests', 'timeFrame': '52 weeks', 'description': 'Immunoglobulin G and its subclasses (IgG 1, 2, 3, and 4), immunoglobulin M, immunoglobulin A, peripheral blood B-cell count, and peripheral blood T-cell count'}, {'measure': 'Plasma ONO-4059 concentration', 'timeFrame': '52 weeks'}, {'measure': 'Immunophenotyping', 'timeFrame': '52 weeks', 'description': 'Level of naive-B cell, memory-B cell, plasmablast etc.'}, {'measure': 'Cytokines and chemokines', 'timeFrame': '52 weeks', 'description': 'Level of tumor necrosis factor-α, interleukin (IL)-8, IL-13, IL-17, C-X-C motif chemokine ligand 13 etc.'}, {'measure': 'RNA sequencing', 'timeFrame': '52 weeks'}, {'measure': 'Anti-virus antibody', 'timeFrame': '52 weeks'}, {'measure': 'Recurrence rate (the proportion of subjects meeting the definition of recurrence) and time to recurrence', 'timeFrame': '52 weeks', 'description': 'Definition of recurrence: In patients with controlled disease, the presence of three or more new lesions in a month that do not spontaneously resolve within a week, or the expansion of existing lesions Definition of time to recurrence: The period from achieving disease control to recurrence'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pemphigus', 'Steroid-resistant Pemphigus']}, 'descriptionModule': {'briefSummary': 'ONO-4059-10:Multicenter, placebo-controlled, randomized, double-blind, Phase 3 study in patients with steroid-resistant pemphigus'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of pemphigus\n* Patients with a re-increase in the pemphigus disease area index (PDAI) score before oral corticosteroid tapering to 10mg/day of prednisolone (PSL) equivalent\n\nExclusion Criteria:\n\n* Patients with an active infection\n* Patients with malignancy\n* Patients with past history of serious allergy or anaphylaxis'}, 'identificationModule': {'nctId': 'NCT06696716', 'briefTitle': 'ONO-4059 Study in Patients With Steroid-resistant Pemphigus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ono Pharmaceutical Co. Ltd'}, 'officialTitle': 'ONO-4059-10:Multicenter, Placebo-controlled, Randomized, Double-blind, Phase 3 Study in Patients With Steroid-resistant Pemphigus (BRILLIANT Study)', 'orgStudyIdInfo': {'id': 'ONO-4059-10'}, 'secondaryIdInfos': [{'id': 'jRCT2031220043', 'type': 'REGISTRY', 'domain': 'Japan Registry of Clinical Trials'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ONO-4059', 'interventionNames': ['Drug: ONO-4059']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: ONO-4059 placebo']}], 'interventions': [{'name': 'ONO-4059', 'type': 'DRUG', 'otherNames': ['Tirabrutinib hydrochloride'], 'description': "Tirabrutinib is a Bruton's Tyrosine Kinase Inhibitor. Tirabrutinib will be administered orally at a dose of 80 mg once daily after a meal (breakfast, lunch, or dinner).", 'armGroupLabels': ['ONO-4059']}, {'name': 'ONO-4059 placebo', 'type': 'DRUG', 'description': 'Placebo will be administered orally once daily after a meal (breakfast, lunch, or dinner).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Ichinomiya Municipal Hospital', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Nagoya City University Hospital', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Ehime', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'facility': 'Ehime University Hospital'}, {'city': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Kurume University Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukushima', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Fukushima Medical University Hospital', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'city': 'Gunma', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'facility': 'Gunma University Hospital'}, {'city': 'Hokkaido', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Hokkaido University Hospital'}, {'city': 'Kagoshima', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Kagoshima University Hospital', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'St.Marianna University School of Medicine Hospital', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Tokai University Hospital', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kanagawa', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Yokohama City University Hospital', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kumamoto', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Kumamoto University Hospital', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kyoto', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'University Hospital Kyoto Prefectural University of Medicine', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Niigata', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Niigata University Medical & Dental Hospital', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Okayama', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Kawasaki Medical School Hospital', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Okinawa', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'University of the Ryukyus Hospital', 'geoPoint': {'lat': 26.33583, 'lon': 127.80139}}, {'city': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Kindai university hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Osaka Metropolitan University Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Saitama', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Saitama Medical Center', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Shiga', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'facility': 'Shiga University of Medical Science Hospital', 'geoPoint': {'lat': 36.02247, 'lon': 138.13005}}, {'city': 'Tochigi', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Jichi Medical University Hospital', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Keio University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Tokyo Medical and Dental University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': "Tokyo Women'ｓ Medical University Hospital", 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Yamagata', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'facility': 'Yamagata University Hospital', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}], 'centralContacts': [{'name': 'North America Clinical Trial Support Desk', 'role': 'CONTACT', 'email': 'clinical_trial@ono-pharma.com', 'phone': '+18665877745(Toll-Free)'}, {'name': 'International Clinical Trial Support Desk', 'role': 'CONTACT', 'email': 'clinical_trial@ono-pharma.com', 'phone': '+17162141777(Standard)'}], 'overallOfficials': [{'name': 'Project Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ono Pharmaceutical Co. Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}