ONO-4059 phase II study(ONO-4059-06)

ONO-4059 phase II study: Multicenter, open-label, uncontrolled, single-arm study in patients with refractory pemphigus(ONO-4059-06)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224170

Enrollment

Registered

2018-12-04

Start date

2019-01-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory pemphigus

Interventions

investigational material(s) Generic name etc : ONO-4059 INN of investigational material : Tirabrutinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigatio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with a diagnosis of pemphigus 2. Patients with a re-increase in the pemphigus disease area index (PDAI) score before oral corticosteroid tapering to 10mg/day of PSL equivalent despite appropriate treatment with an oral corticosteroid and a second-line treatment recommended by the pemphigus treatment guidelines

Exclusion criteria

Exclusion criteria: 1. Patients with an active infection 2. Patients with malignancy 3. Patients with past history of serious allergy or anaphylaxis

Design outcomes

Primary

Measure	Time frame
efficacy Remission rate	—

Secondary

Measure	Time frame
safety pharmacokinetics Adverse events, adverse drug reactions, plasma drug concentration	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026