ONO-4059 Study in Patients With Steroid-resistant Pemphigus

Ono Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Pemphigus; Steroid-resistant Pemphigus

Treatments: Drug: ONO-4059; Drug: ONO-4059 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06696716

ONO-4059-10

jRCT2031220043 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 34 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Patients with an active infection
• Patients with malignancy
• Patients with past history of serious allergy or anaphylaxis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

ONO-4059

Active Comparator group

Treatment:

Drug: ONO-4059

Placebo

Placebo Comparator group

Treatment:

Drug: ONO-4059 placebo