A Phase 3 interventional study of ONO-4059 and ONO-4059 placebo in Pemphigus and Steroid-resistant Pemphigus, sponsored by Ono Pharmaceutical Co., Ltd.. Active, not recruiting at 25 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Ono Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
ONO-4059-10:Multicenter, placebo-controlled, randomized, double-blind, Phase 3 study in patients with steroid-resistant pemphigus
76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.
This study's planned enrollment of 34 is above the median of 30 across 53 interventional studies indexed under Pemphigus.
Browse Pemphigus studies →Ono Pharmaceutical Co., Ltd. is the lead sponsor of 49 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: ONO-4059
Drug: ONO-4059 placebo
Tirabrutinib is a Bruton's Tyrosine Kinase Inhibitor. Tirabrutinib will be administered orally at a dose of 80 mg once daily after a meal (breakfast, lunch, or dinner).
Also known as: Tirabrutinib hydrochloride
Placebo will be administered orally once daily after a meal (breakfast, lunch, or dinner).
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.
CR: Absence of pemphigus-related blisters or new erythema that lasts for 8 weeks during treatment with ONO-4059 plus an oral corticosteroid (≤10 mg/day prednisolone-equivalent) or minimal adjunctive therapy. PR: Occurrence of only a transient lesion that resolves within 1 week without an increased dose of an oral corticosteroids, without treatment, or with a topical corticosteroid, etc., during treatment with ONO-4059 plus an oral corticosteroid (≤10 mg/day prednisolone-equivalent) or minimal adjunctive therapy for 8 weeks.
Time frame: 52 weeks
Remission rate
remission rate \[proportion of subjects who achieve complete or partial remission\], complete remission rate, partial remission rate
Time frame: 52 weeks
Pemphigus Disease Area Index (PDAI) score
Pemphigus Disease Area Index (PDAI). PDAI activity score cutoffs were defined as 0 to 8 for mild, 9 to 24 for moderate, and 25 or higher for severe disease.
Time frame: 52 weeks
Efficacy 1 rate (proportion of subjects for whom the definition of efficacy 1 is applicable)
Definition of efficacy 1: Decreases in PDAI score and oral corticosteroid dose from baseline
Time frame: 52 weeks
Efficacy 2 rate (proportion of subjects for whom the definition of efficacy 2 is applicable)
Definition of efficacy 2: PDAI score is 0 and oral corticosteroid dose \<= 10 mg/day
Time frame: 52 weeks
Disease control rate (proportion of subjects for whom the definition of disease control is applicable)
Definition of disease control: Formation of nascent lesions stops and existing lesions begin to resolve
Time frame: 52 weeks
Rescue therapy rate
Proportion of subjects who received rescue therapy
Time frame: 52 weeks
Pemphigus autoantibody titer
Anti-desmoglein 1 antibodies, anti-desmoglein 3 antibodies
Time frame: 52 weeks
Oral corticosteroid dose
At the equivalent dose of prednisolone
Time frame: 52 weeks
QOL evaluation
The Dermatology Life Quality Index (DLQI) score is measured by questionnaire.
Time frame: 52 weeks
Adverse events and adverse drug reactions
Time frame: 52 weeks
Clinical laboratory tests
Number of participants with clinical laboratory abnormalities (including haematology, clinical chemistry and urinalysis).
Time frame: 52 weeks
12-lead ECG
Heart rate, RR interval, PR interval, QRS duration, QT interval and QTcF
Time frame: 52 weeks
Vital signs
Systolic/diastolic blood pressure
Time frame: 52 weeks
Vital signs
Body temperature
Time frame: 52 weeks
Immunological tests
Immunoglobulin G and its subclasses (IgG 1, 2, 3, and 4), immunoglobulin M, immunoglobulin A, peripheral blood B-cell count, and peripheral blood T-cell count
Time frame: 52 weeks
Plasma ONO-4059 concentration
Time frame: 52 weeks
Immunophenotyping
Level of naive-B cell, memory-B cell, plasmablast etc.
Time frame: 52 weeks
Cytokines and chemokines
Level of tumor necrosis factor-α, interleukin (IL)-8, IL-13, IL-17, C-X-C motif chemokine ligand 13 etc.
Time frame: 52 weeks
RNA sequencing
Time frame: 52 weeks
Anti-virus antibody
Time frame: 52 weeks
Recurrence rate (the proportion of subjects meeting the definition of recurrence) and time to recurrence
Definition of recurrence: In patients with controlled disease, the presence of three or more new lesions in a month that do not spontaneously resolve within a week, or the expansion of existing lesions Definition of time to recurrence: The period from achieving disease control to recurrence
Time frame: 52 weeks
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tirabrutinib
Ono Pharmaceutical Co., Ltd. →