Trial of efficacy and safety of NS-229 versus placebo in patients with Eosinophilic Granulomatosis

JRCT ID: jRCT2031230526

Registered date:21/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: eosinophilic granulomatosis with polyangiitis(EGPA)
• Date of first enrollment: 29/05/2024
• Target sample size: 45
• Countries of recruitment: US,Japan,Canada,Japan,UK,Japan,Germany,Japan,Italy,Japan,France,Japan,Spain,Japan
• Study type: Interventional
• Intervention(s): Subjects receive multiple oral doses of NS-229 or placebo.

Outcome(s)

Primary Outcome

The proportion of subjects in remission (oral glucocorticoid [OGC] 4.0)* at Week 28 of the study treatment period.
*Definition of remission (OGC 4.0): Birmingham Vasculitis Activity Score (BVAS) of 0 AND OGC dose of prednisolone/prednisone <=4.0 mg/day.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1)Male or female subjects aged >18 years at the time the informed consent form is signed
(2)Diagnosis of EGPA
(3)Subjects receive background OGC dose of >=7.5 mg/day with or without stable treatment with mepolizumab.

Exclude criteria

(1) Current diagnosis of either granulomatosis with polyangiitis or microscopic polyangiitis
(2) Imminently life-threatening EGPA disease

Related Information

• Primary Sponsor: Seita Takeshi