ONO-4059 Study in Patients With Steroid-resistant Pemphigus

Launched by ONO PHARMACEUTICAL CO. LTD · Nov 18, 2024

Keywords

ClinConnect Summary

The ONO-4059 study is a research trial looking at a new treatment for patients with a condition called steroid-resistant pemphigus, which is an autoimmune disease that causes painful sores on the skin and mucous membranes. This study is in the later stages (Phase 3) and is being conducted at multiple locations. It aims to see if the new treatment can help manage symptoms better than a placebo, which is a treatment that does not contain any active medication. The trial is currently looking for participants, and anyone aged 7304 or older can apply.

To be eligible for this study, participants must have a confirmed diagnosis of pemphigus and have experienced a worsening of their condition before decreasing their corticosteroid medication to a low dose. However, individuals with active infections, a history of cancer, or severe allergies cannot take part in the trial. If you join the study, you can expect to receive either the new treatment or a placebo for a set period while being closely monitored by healthcare professionals. This is an important opportunity for those who are struggling with their condition and may help improve future treatments for pemphigus.

Gender

ALL

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