ONO-4059 Study in Patients With Steroid-resistant Pemphigus
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20+
SponsorOno Pharmaceutical Co., Ltd.
About this trial
ONO-4059-10:Multicenter, placebo-controlled, randomized, double-blind, Phase 3 study in patients with steroid-resistant pemphigus
Eligibility criteria
Qualifiers
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
Disqualifiers
Patients with an active infection
Patients with malignancy
Patients with past history of serious allergy or anaphylaxis
Trial design
Treatments tested in this trial
- ONO-4059
- ONO-4059 placebo
Treatment groups
34 Participants
are divided into 2 treatment groupsLocations
25Ichinomiya Municipal Hospital Aichi Japan
Nagoya City University Hospital Aichi Japan
Ehime University Hospital Ehime Japan
Kurume University Hospital Fukuoka Japan
Sponsors and collaborators
Ono Pharmaceutical Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov