At a glance
ClinicalIndex Comparison RecordPhase 3Active· 135 enrolled
Drug / intervention
Inebilizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease
In Brief
A Phase 3 clinical trial evaluating Inebilizumab and Placebo for IgG4 Related Disease. Active but no longer recruiting, targeting 135 participants across 72 sites in 21 countries.
Detailed Summary
This study aims to evaluate the efficacy and safety of inebilizumab for the prevention of flare of Immunoglobulin G4-related disease (IgG4-RD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIgG4 Related Disease
CountriesArgentina, Australia, Canada, China, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Poland, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3Active
202120222023202420252026202720282029
First PostedSep 2020
Enrollment StartDec 2020
Primary CompletionApr 2024
TodayJul 2026
Study CompletionOct 2028
First PostedSep 7, 2020
Enrollment StartDec 4, 2020
Primary CompletionApr 9, 2024
Study CompletionOct 31, 2028
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.8 years ago
Interventions
Inebilizumabdrug
Inebilizumab is a monoclonal antibody that depletes B cells.
Placeboother
Placebo