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

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of NS-229 in the Treatment of Eosinophilic Granulomatosis with Polyangiitis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031230526
Enrollment
45
Registered
2023-12-21
Start date
2024-05-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

eosinophilic granulomatosis with polyangiitis(EGPA)

Interventions

Subjects receive multiple oral doses of NS-229 or placebo.

Sponsors

Horiguchi Tatsuya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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 or benralizumab.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Canada, France, Germany, Italy, Japan, Spain, UK, US

Contacts

Public ContactOperations Clinical

Nippon Shinyaku Co., Ltd.

zz_mail_clinical-trials@po.nippon-shinyaku.co.jp+81-120-40-8930

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026