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Inebilizumab in Children With Immunoglobulin G4-related Disease (IgG4-RD)
NCT07222553Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Oct 2026
- Primary completion
- Jun 2031
- Countries
- 7
- Sponsor
- Amgen
- Modality
- Monoclonal Antibodies
- Drugs
- inebilizumab
- Conditions
- immunoglobulin G4-related disease (IgG4-RD)
01
Overview
Phase 2, open-label, single-arm trial of inebilizumab in immunoglobulin G4-related disease (IgG4-RD), sponsored by Amgen. Primary endpoints: Maximum Plasma Concentration, Area Under the Plasma Concentration-time Curve and 9 more. Planned start Oct 2026; status: not yet recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Inebilizumab
Participants will receive Inebilizumab via intravenous (IV) infusion.
03
Who it enrols
Children aged 2 to <18 years weighing >= 17 kg with a clinical diagnosis of IgG4-RD meeting 2019 ACR/EULAR classification criteria, requiring treatment in addition to or other than glucocorticoids. Excludes patients with significant hepatic, renal, or hematological dysfunction, severe infections, immunodeficiency, or recent use of certain immunosuppressive or B-cell depleting therapies.
04
Endpoints
Primary
Maximum Plasma Concentration
Area Under the Plasma Concentration-time Curve
Clearance
Terminal Half-life
Volume of Distribution at Steady-state
Secondary
Time-to-first Treated Flare
Percentage of Flare-free Participants
Annualized Flare Rate
Antidrug Antibodies
Percent Reduction from Baseline in Daily Glucocorticoid Dose
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