RecruitingPhase 3

ONO-4059 Study in Patients With Steroid-resistant Pemphigus

Japan34 participantsStarted 2022-08-15

Plain-language summary

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

Who can participate

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT06696716

SponsorOno Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

North America Clinical Trial Support Desk

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

View on ClinicalTrials.gov More Pemphigus trials