Phase 3 study of GGS in patients with CSS/AGA

Double-blind, Randomized clinical study of GGS (Intravenous Immunoglobulin) in patients with CSS/AGA. Phase 3 study.

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220238

Enrollment

Registered

2006-05-02

Start date

2006-05-02

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

Churg-Strauss Syndrome (CSS) / Allergic Granulomatous Angiitis (AGA)

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 Dos

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with CSS/AGA associated with neuropathy responding poorly to traditional therapy (steroid therapy, etc.) Main Inclusion Criteria 1.Patients with a diagnosis of definite CSS/AGA according to "Diagnostic criteria for allergic granulomatosus angiitis (Churg-Strauss Syndrome) proposed by the Research Committee of Intractable Vasculitis, Ministry of Health and Welfare, Japan (1998)" 2.Patients who have underwent the following steroid therapy for CSS/AGA A:Treatment with corticosteroid at 40 mg/day as prednisolone for at least 4 weeks as remission induction therapy B:After the tapering following A, treatment with corticosteroid at a constant dose of 5 mg/day or higher and 20 mg/day or lower as prednisolone for at least 4 weeks 3.Patients who have at least one impaired site with a manual muscle testing (MMT) score of not more than 3 and have a MMT sum score of not more than 130

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 serious renal disorder 4.Patients with cerebrovascular or cardiovascular disorder or its history 5.Patients with a high risk of thromboembolism 6.Patients with hemolytic/blood loss anemia 7.Patients with reduced cardiac function 8.Patients with immunodeficiency or under immunosuppression 9.Pregnant, potentially pregnant, or lactating patients 10.Patients who are being treated in other clinical study or who complete other clinical study within the last 4 weeks

Design outcomes

Secondary

Measure	Time frame
Main secondary endpoints Efficacy 1. Neuropathy Safety 1. Subjective symptoms 2. Objective findings 3. Clinical laboratory tests Manual muscle test (MMT), Modified Barthel Index, VAS (Visual Analogue Scale)	—

Primary

Measure	Time frame
Neuropathy Manual muscle test (MMT)	—

Outcome results

None listed

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