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Phase II study on NKT-01 in patients with refractory Wegener's granulomatosis

Phase II study on NKT-01 in patients with refractory Wegener's granulomatosis

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220107
Enrollment
Unknown
Registered
2005-09-12
Start date
2005-09-12
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

Refractory Wegener's granulomatosis

Interventions

investigational material(s) Generic name etc : Spanidin (Gusperimus, NKT-01) INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administr

Sponsors

Nippon Kayaku Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Diagnosis of Wegener's granulomatosis according to the ACR criteria and the Chapel Hill Consensus Conference definition; BVAS >= 4; Treatment duration >= 3 months with CYC or >= 6 months with MTX; Age between 18 and 80 years; WBC >= 4,000/mm3. Exclusion Criteria: Pregnant or nursing mothers and women of childbearing age; Active bacterial/viral infection; History of HIV infection or active HBV or HCV infection.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Efficacy—

Outcome results

None listed

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