Condition: Immunoglobulin G4 Related Disease · Sponsor: Sanofi
This is a Phase 3, parallel group, 2-arm, randomized, double blind, placebo-controlled, 52-week treatment study to assess the efficacy and safety of rilzabrutinib as a treatment for adult patients with active IgG4-RD. The purpose of this study is to measure time to adjudicated IgG4-RD clinical disease flare, and other relevant efficacy endpoints including flare-free rate, control of IgG4-RD disease activity, use of GC rescue and safety parameters such as treatment-emergent adverse events, clinical laboratory values and electrocardiograms (ECG) in participants aged 18 years and above, diagnosed with IgG4-RD and treated with rilzabrutinib tablets over a 52-week placebo-controlled period. Study details include: The study duration will be up to 60 weeks, including a Screening period of 4 to 6 weeks, a 52-week double blind treatment period, and 2 weeks of follow up (plus an optional OLE of 108 weeks). The number of visits will be 16 (plus an optional 9 visits during the OLE).
This description comes directly from the study's public registry record.
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| Kaiser Permanente - Fontana Medical Center- Site Number : 8400015 | Fontana, California, United States | Recruiting |
| San Jose Clinical Trials- Site Number : 8400016 | San Jose, California, United States | Recruiting |
| Solace Clinical Research - Tustin- Site Number : 8400020 | Tustin, California, United States | Recruiting |
| Life Clinical Trials - Margate - Colonial Drive- Site Number : 8400002 | Margate, Florida, United States | Recruiting |
| Schiff Center for Liver Diseases- Site Number : 8400010 | Miami, Florida, United States | Recruiting |
| Vitalia Medical Research - Margate- Site Number : 8400025 | Palm Beach Gardens, Florida, United States | Recruiting |
| Emory University School of Medicine - Atlanta- Site Number : 8400013 | Atlanta, Georgia, United States | Recruiting |
| Primeway Clinical Research- Site Number : 8400019 | Fayetteville, Georgia, United States | Recruiting |
| Massachusetts General Hospital- Site Number : 8400008 | Boston, Massachusetts, United States | Recruiting |
| Mayo Clinic in Rochester - Minnesota- Site Number : 8400017 | Rochester, Minnesota, United States | Recruiting |
| Cleveland Clinic - Cleveland- Site Number : 8400001 | Cleveland, Ohio, United States | Recruiting |
| Ohio State University Wexner Medical Center- Site Number : 8400024 | Columbus, Ohio, United States | Recruiting |
+ 67 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07190196