RecruitingPhase 3NCT06696716

ONO-4059 Study in Patients With Steroid-resistant Pemphigus

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

Sponsor

Ono Pharmaceutical Co., Ltd.

Enrollment

34 participants

Start Date

Aug 15, 2022

Study Type

INTERVENTIONAL

Conditions

Pemphigus Steroid-resistant Pemphigus

Summary

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

Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ONO-4059 and a drug called ONO-4059 placebo for people with pemphigus and steroid-resistant pemphigus. The study is currently recruiting participants at 25 locations. People eligible for this study include aged 20 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGONO-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).

DRUGONO-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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06696716

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