TRUE NORTH OLE is an ongoing trial that enrolled participants who were nonresponders at the end of induction, experienced disease relapse during maintenance, or completed maintenance treatment in the Phase 3 TRUE NORTH study or remained at study closure and received once-daily oral ZEPOSIA 0.92 mg in the Phase 2 TOUCHSTONE OLE. A total of 823 patients from TRUE NORTH entered the TRUE NORTH OLE as of the cut-off date (September 30, 2020). Mean ZEPOSIA exposure in the OLE was 1.5 years.3,4
Clinical remission, clinical response, endoscopic improvement, and corticosteroid (CS)-free remission were evaluated at Week 46 for all patients who entered the OLE from the TRUE NORTH parent study and in a subset of patients in clinical remission at Week 52 and had continuous ZEPOSIA exposure.2,3
Data were analyzed in the ITT population using OC and NRI. OC used the number of patients remaining in the study at the corresponding time point. NRI used the number of patients remaining in the study at the corresponding time point and those who withdrew before the time point but would have reached the time point if they had stayed.3
In the NRI analysis of a subset of patients in clinical remission at Week 52 and had continuous ZEPOSIA exposure, 53% (n=30/57) were in clinical remission at Week 98 (Week 46 of OLE).2
For all patients in OLE (N=823)3:
- In the OC analysis, 45% of patients were in clinical remission at 46 weeks post-OLE entry
- In the NRI analysis, 28% of patients were in clinical remission at 46 weeks post-OLE entry