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ONO-4059 Study in Patients With Steroid-resistant Pemphigus

NCT06696716 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-01-07

No results posted yet for this study

Summary

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

Conditions

  • Pemphigus
  • Steroid-resistant Pemphigus

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).

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Project Leader · Ono Pharmaceutical Co. Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2027-09-30
Completion
2029-03-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06696716 on ClinicalTrials.gov