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)
Ono Pharmaceutical Co. Ltd
34 participants
Aug 15, 2022
INTERVENTIONAL
Conditions
Summary
ONO-4059-10:Multicenter, placebo-controlled, randomized, double-blind, Phase 3 study in patients with steroid-resistant pemphigus
Eligibility
Inclusion Criteria2
- Patients with a diagnosis of pemphigus
- 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 Criteria3
- Patients with an active infection
- Patients with malignancy
- Patients with past history of serious allergy or anaphylaxis
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Interventions
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 will be administered orally once daily after a meal (breakfast, lunch, or dinner).
Locations(25)
View Full Details on ClinicalTrials.gov
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NCT06696716