A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
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- STATUS
- Recruiting
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- End date
- Jun 23, 2024
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- participants needed
- 160
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- sponsor
- Viela Bio (acquired by Horizon Therapeutics)
Summary
This study aims to define the efficacy and safety of inebilizumab for the prevention of flare of IgG4-related disease (IgG4-RD).
Description
After a screening period of up to 28 days, subjects with IgG4-RD at high risk of flare due to multi-organ disease and recent active disease will be randomized in a 1:1 ratio to receive intravenous (IV) inebilizumab or placebo after premedication during the 52-week randomized control period (RCP). All subjects will receive an initial tapering dose of glucocorticoids (GCs) to complete treatment of their active disease. Flares occurring during study will be treated. The primary endpoint is time to a first adjudication committee-determined, investigator-treated disease flare during the RCP.. The primary analysis will be conducted when the last subject completes the RCP visit or discontinues the RCP. This study includes an optional 52-week open-label treatment period. The expected duration of each subject's participation in this study is up to 400 days (screening and RCP) or, for eligible subjects who enroll in the optional OLP, up to 813 days (screening, RCP, interval between RCP and OLP, and OLP).
Details
| Condition | IgG4 Related Disease |
|---|---|
| Treatment | Placebo, Inebilizumab |
| Clinical Study Identifier | NCT04540497 |
| Sponsor | Viela Bio (acquired by Horizon Therapeutics) |
| Last Modified on | 23 April 2022 |
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