ONO-4059 Study in Patients With Steroid-resistant Pemphigus
NCT ID: NCT06696716
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
34 participants
INTERVENTIONAL
2022-08-15
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ONO-4059
ONO-4059
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).
Placebo
ONO-4059 placebo
Placebo will be administered orally once daily after a meal (breakfast, lunch, or dinner).
Interventions
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ONO-4059
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).
ONO-4059 placebo
Placebo will be administered orally once daily after a meal (breakfast, lunch, or dinner).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with a re-increase in the pemphigus disease area index (PDAI) score before oral corticosteroid tapering to 10mg/day of prednisolone (PSL) equivalent
Exclusion Criteria
* Patients with malignancy
* Patients with past history of serious allergy or anaphylaxis
20 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Project Leader
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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Ichinomiya Municipal Hospital
Aichi, , Japan
Nagoya City University Hospital
Aichi, , Japan
Ehime University Hospital
Ehime, , Japan
Kurume University Hospital
Fukuoka, , Japan
Fukushima Medical University Hospital
Fukushima, , Japan
Gunma University Hospital
Gunma, , Japan
Hokkaido University Hospital
Hokkaido, , Japan
Kagoshima University Hospital
Kagoshima, , Japan
St.Marianna University School of Medicine Hospital
Kanagawa, , Japan
Tokai University Hospital
Kanagawa, , Japan
Yokohama City University Hospital
Kanagawa, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Kawasaki Medical School Hospital
Okayama, , Japan
University of the Ryukyus Hospital
Okinawa, , Japan
Kindai university hospital
Osaka, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Saitama Medical Center
Saitama, , Japan
Shiga University of Medical Science Hospital
Shiga, , Japan
Jichi Medical University Hospital
Tochigi, , Japan
Keio University Hospital
Tokyo, , Japan
Tokyo Medical and Dental University Hospital
Tokyo, , Japan
Tokyo Women'ｓ Medical University Hospital
Tokyo, , Japan
Yamagata University Hospital
Yamagata, , Japan
Countries
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Central Contacts
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Other Identifiers
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jRCT2031220043
Identifier Type: REGISTRY
Identifier Source: secondary_id
ONO-4059-10
Identifier Type: -
Identifier Source: org_study_id
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