ONO-4059-10:Phase 3 study in patients with steroid-resistant pemphigus

JRCT ID: jRCT2031220043

Registered date:27/04/2022

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: steroid-resistant pemphigus
• Date of first enrollment: 15/08/2022
• Target sample size: 34
• Study type: Interventional
• Intervention(s): ONO-4059 will be administered orally once daily after a meal.

Outcome(s)

• Primary Outcome: Efficacy
• Secondary Outcome: Efficacy, Safety, Exploratory objective

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

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

Related Information

• Primary Sponsor: Osawa Masahiro