ONO-4059 Study in Patients With Steroid-resistant Pemphigus

Last updated: February 12, 2025
Sponsor: Ono Pharmaceutical Co. Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

ONO-4059

ONO-4059 placebo

Clinical Study ID

NCT06696716
ONO-4059-10
jRCT2031220043
  • Ages > 20
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with a diagnosis of pemphigus

  • Patients with a re-increase in the pemphigus disease area index (PDAI) score beforeoral corticosteroid tapering to 10mg/day of prednisolone (PSL) equivalent

Exclusion

Exclusion Criteria:

  • Patients with an active infection

  • Patients with malignancy

  • Patients with past history of serious allergy or anaphylaxis

Study Design

Total Participants: 34
Treatment Group(s): 2
Primary Treatment: ONO-4059
Phase: 3
Study Start date:
August 15, 2022
Estimated Completion Date:
March 31, 2029

Connect with a study center

  • Ichinomiya Municipal Hospital

    Aichi,
    Japan

    Site Not Available

  • Nagoya City University Hospital

    Aichi,
    Japan

    Site Not Available

  • Kurume University Hospital

    Fukuoka,
    Japan

    Site Not Available

  • Fukushima Medical University Hospital

    Fukushima,
    Japan

    Active - Recruiting

  • Hokkaido University Hospital

    Hokkaido,
    Japan

    Active - Recruiting

  • Kagoshima University Hospital

    Kagoshima,
    Japan

    Active - Recruiting

  • St.Marianna University School of Medicine Hospital

    Kanagawa,
    Japan

    Active - Recruiting

  • Tokai University Hospital

    Kanagawa,
    Japan

    Active - Recruiting

  • Yokohama City University Hospital

    Kanagawa,
    Japan

    Active - Recruiting

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto,
    Japan

    Active - Recruiting

  • Niigata University Medical & Dental Hospital

    Niigata,
    Japan

    Active - Recruiting

  • Kawasaki Medical School Hospital

    Okayama,
    Japan

    Site Not Available

  • Kindai university hospital

    Osaka,
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital

    Osaka,
    Japan

    Active - Recruiting

  • Saitama Medical Center

    Saitama,
    Japan

    Active - Recruiting

  • Jichi Medical University Hospital

    Tochigi,
    Japan

    Active - Recruiting

  • Keio University Hospital

    Tokyo,
    Japan

    Active - Recruiting

  • Tokyo Medical and Dental University Hospital

    Tokyo,
    Japan

    Active - Recruiting

  • Tokyo Women'ｓ Medical University Hospital

    Tokyo,
    Japan

    Site Not Available

  • Yamagata University Hospital

    Yamagata,
    Japan

    Site Not Available

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