Phase 3 study of GGS in patients with microscopic polyangiitis (MPA)

Randomized, placebo-controlled, double-blind, parallel-group clinical study of GGS in patients with microscopic polyangiitis (MPA) (Phase 3 study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222344

Enrollment

Registered

2013-12-25

Start date

2014-03-07

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

Microscopic polyangiitis (MPA)

Interventions

investigational material(s) Generic name etc : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS) INN of investigational material : - Therapeutic category code : 634 Human blood preparations Do

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with microscopic polyangiitis associated with neuropathy Main Inclusion Criteria 1.Patients diagnosed as "definite" or "probable" according to " Diagnostic Criteria of Microscopic Polyangiitis (MPA)" specified in the " Guideline for management of vasculitis syndrome " (JCS 2008) 2. Patients who have underwent the following steroid therapy for MPA A: Patients who have underwent the following steroid therapy as remission induction therapy 1) Treatment with corticosteroid at 40 mg/day (or 0.6 mg/kg/day) as prednisolone for at least 2 weeks 2) Treatment with corticosteroid at 20 mg/day or higher for 8 weeks or longer including the above 1) following the above 1) B: After the tapering following A, treatment with corticosteroid at a constant dose of 2.5 mg/day or higher and 15 mg/day or lower as prednisolone for at least 4 weeks until the day of consent 3. Patients for whom the presence of clinical symptoms of peripheral neuropathy (muscle weakness, pain, and numbness of the extremities, etc.) during remission induction therapy for MPA can be confirmed in medical records

Exclusion criteria

Exclusion criteria: Main Exclusion Criteria 1. Patients with a history of shock or hypersensitivity to any human immunoglobulin preparation 2. Patients with IgA deficiency 3. Patients with hemolytic/blood loss anemia 4. Patients with reduced cardiac function 5. Patients with end-stage renal disease 6. Patients with cerebrovascular or cardiovascular disorder 7. Patients with a high risk of thromboembolism 8. Patients with immunodeficiency or under immunosuppression 9. Pregnant, potentially pregnant, or lactating patients 10. Patients who are being treated in other clinical study

Design outcomes

Primary

Measure	Time frame
efficacy Primary endopoint Neuropathy Evaluation method Manual muscle test (MMT)	—

Secondary

Measure	Time frame
safety efficacy Main secondary endpoints Efficacy 1. Neuropathy 2. Angiitis symptoms Safety 1. Adverse events 2. Vital signs 3. Clinical laboratory tests Evaluation method Manual muscle test (MMT), BVAS (Birmingham Vasculitis Activity Score)	—

Countries

Japan

Outcome results

None listed

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