A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
135actual
Sites
72
Countries
Argentina, Australia, Canada +18
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-12-04 | actual | When the study began enrolling |
| Primary completion | 2024-04-09 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-10-31 | estimated | The whole study's end, after follow-up |
| First posted | 2020-09-07 | actual | When this record first appeared on the registry |
| Results posted | 2025-06-25 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-12-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- IgG4 Related Disease
Interventions
- Drug: Inebilizumab
- Other: Placebo
Primary outcome
what the primary-completion date above is the date OFRCP: Time to Disease Flare
measured Up to Week 52
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-08-08 · 1.6 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-05-15 · 993 KB · SAP_001.pdf
Publications
- PMID 41786624 — linked by the registry
- PMID 39541094 — linked by the registry
- PMID 37792260 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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