NCT06696716

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_3

Timeline
36mo left

Started Aug 2022

Longer than P75 for phase_3

Geographic Reach
1 country

25 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Aug 2022Mar 2029

Study Start

First participant enrolled

August 15, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

5.1 years

First QC Date

November 7, 2024

Last Update Submit

January 5, 2026

Conditions

PemphigusSteroid-resistant Pemphigus

Outcome Measures

Primary Outcomes (1)

  • 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.

    52 weeks

Secondary Outcomes (21)

  • Remission rate

    52 weeks

  • Pemphigus Disease Area Index (PDAI) score

    52 weeks

  • Efficacy 1 rate (proportion of subjects for whom the definition of efficacy 1 is applicable)

    52 weeks

  • Efficacy 2 rate (proportion of subjects for whom the definition of efficacy 2 is applicable)

    52 weeks

  • Disease control rate (proportion of subjects for whom the definition of disease control is applicable)

    52 weeks

  • +16 more secondary outcomes

Study Arms (2)

ONO-4059

ACTIVE COMPARATOR
Drug: ONO-4059

Placebo

PLACEBO COMPARATOR
Drug: ONO-4059 placebo

Interventions

ONO-4059DRUG

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
ONO-4059
ONO-4059 placeboDRUG

Placebo will be administered orally once daily after a meal (breakfast, lunch, or dinner).

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Ichinomiya Municipal Hospital

Aichi, Japan

RECRUITING

Nagoya City University Hospital

Aichi, Japan

RECRUITING

Ehime University Hospital

Ehime, Japan

RECRUITING

Kurume University Hospital

Fukuoka, Japan

RECRUITING

Fukushima Medical University Hospital

Fukushima, Japan

RECRUITING

Gunma University Hospital

Gunma, Japan

RECRUITING

Hokkaido University Hospital

Hokkaido, Japan

RECRUITING

Kagoshima University Hospital

Kagoshima, Japan

RECRUITING

St.Marianna University School of Medicine Hospital

Kanagawa, Japan

RECRUITING

Tokai University Hospital

Kanagawa, Japan

RECRUITING

Yokohama City University Hospital

Kanagawa, Japan

RECRUITING

Kumamoto University Hospital

Kumamoto, Japan

RECRUITING

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Japan

RECRUITING

Niigata University Medical & Dental Hospital

Niigata, Japan

RECRUITING

Kawasaki Medical School Hospital

Okayama, Japan

RECRUITING

University of the Ryukyus Hospital

Okinawa, Japan

RECRUITING

Kindai university hospital

Osaka, Japan

RECRUITING

Osaka Metropolitan University Hospital

Osaka, Japan

RECRUITING

Saitama Medical Center

Saitama, Japan

RECRUITING

Shiga University of Medical Science Hospital

Shiga, Japan

RECRUITING

Jichi Medical University Hospital

Tochigi, Japan

RECRUITING

Keio University Hospital

Tokyo, Japan

RECRUITING

Tokyo Medical and Dental University Hospital

Tokyo, Japan

RECRUITING

Tokyo Women'ｓ Medical University Hospital

Tokyo, Japan

RECRUITING

Yamagata University Hospital

Yamagata, Japan

NOT YET RECRUITING

MeSH Terms

Conditions

Pemphigus

Interventions

tirabrutinib

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Project Leader

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Central Study Contacts

North America Clinical Trial Support Desk

CONTACT

+18665877745(Toll-Free)clinical_trial@ono-pharma.com

International Clinical Trial Support Desk

CONTACT

+17162141777(Standard)clinical_trial@ono-pharma.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2024

First Posted

November 20, 2024

Study Start

August 15, 2022

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

March 31, 2029

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

JP(25)