Clinical trial NCT06696716: ONO-4059 Study in Patients With Steroid-resistant Pemphigus
Official title: ONO-4059-10:Multicenter, Placebo-controlled, Randomized, Double-blind, Phase 3 Study in Patients With Steroid-resistant Pemphigus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pemphigus
Steroid-resistant Pemphigus
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-11-20
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: The proportion of patients with a Complete response (CR) or Partial response (PR) at 52 weeks, and maintaining complete/partial remission at 52 weeks from initial remission achievement.
timeFrame: 52 weeks
Secondary outcomes:
measure: Remission rate
timeFrame: 52 weeks
measure: Pemphigus Disease Area Index (PDAI) score
timeFrame: 52 weeks
measure: Efficacy 1 rate (proportion of subjects for whom the definition of efficacy 1 is applicable)
timeFrame: 52 weeks
measure: Efficacy 2 rate (proportion of subjects for whom the definition of efficacy 2 is applicable)
timeFrame: 52 weeks
measure: Disease control rate (proportion of subjects for whom the definition of disease control is applicable)
timeFrame: 52 weeks
measure: Rescue therapy rate
timeFrame: 52 weeks
measure: Pemphigus autoantibody titer
timeFrame: 52 weeks
measure: Oral corticosteroid dose
timeFrame: 52 weeks
measure: QOL evaluation
timeFrame: 52 weeks
measure: Adverse events and adverse drug reactions
timeFrame: 52 weeks
measure: Clinical laboratory tests
timeFrame: 52 weeks
measure: 12-lead ECG
timeFrame: 52 weeks
measure: Vital signs
timeFrame: 52 weeks
measure: Vital signs
timeFrame: 52 weeks
measure: Immunological tests
timeFrame: 52 weeks
measure: Plasma ONO-4059 concentration
timeFrame: 52 weeks
measure: Immunophenotyping
timeFrame: 52 weeks
measure: Cytokines and chemokines
timeFrame: 52 weeks
measure: RNA sequencing
timeFrame: 52 weeks
measure: Anti-virus antibody
timeFrame: 52 weeks
measure: Recurrence rate (the proportion of subjects meeting the definition of recurrence) and time to recurrence
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Ichinomiya Municipal Hospital
city: Aichi
country: Japan
facility: Nagoya City University Hospital
city: Fukuoka
country: Japan
facility: Kurume University Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kanagawa
country: Japan
facility: St.Marianna University School of Medicine Hospital
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Kanagawa
country: Japan
facility: Yokohama City University Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Okayama
country: Japan
facility: Kawasaki Medical School Hospital
city: Osaka
country: Japan
facility: Kindai university hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Saitama
country: Japan
facility: Saitama Medical Center
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University Hospital
city: Tokyo
country: Japan
facility: Tokyo Women'ｓ Medical University Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: