A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease
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|ClinicalTrials.gov Identifier: NCT04540497|
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : April 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|IgG4 Related Disease||Drug: Inebilizumab Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease|
|Actual Study Start Date :||October 26, 2020|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2024|
Inebilizumab administered as an IV infusion.
Inebilizumab is a monoclonal antibody that depletes B cells.
Placebo Comparator: Placebo
Placebo administered as an IV infusion.
- Time to disease flare, defined as the time in days from Day 1 (dosing) to the date of the first treated and Adjudication Committee-determined IgG4 RD flare within the 52-week RCP. [ Time Frame: Day 1 to Day 365 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540497
|Contact: Horizon Therapeuticsfirstname.lastname@example.org|
|Study Director:||Nishi Rampal, MD||Horizon Therapeutics Ireland DAC|