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RECRUITING
NCT06696716
PHASE3

ONO-4059 Study in Patients With Steroid-resistant Pemphigus

Sponsor: Ono Pharmaceutical Co. Ltd

View on ClinicalTrials.gov

Summary

ONO-4059-10:Multicenter, placebo-controlled, randomized, double-blind, Phase 3 study in patients with steroid-resistant pemphigus

Official title: ONO-4059-10:Multicenter, Placebo-controlled, Randomized, Double-blind, Phase 3 Study in Patients With Steroid-resistant Pemphigus (BRILLIANT Study)

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2022-08-15

Completion Date

2029-03-31

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

DRUG

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).

DRUG

ONO-4059 placebo

Placebo will be administered orally once daily after a meal (breakfast, lunch, or dinner).

Locations (25)

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