For adults with moderate-to-severe ulcerative colitis
TRUE NORTH OLE is an ongoing trial that enrolled patients 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 cutoff date (January 10, 2022).2,4,5
OLE endpoints were evaluated at Week 46 and Week 94 for a subset of patients who were in clinical remission or clinical response at Week 52 of the TRUE NORTH parent study and who had continuous ZEPOSIA exposure. Endpoints include clinical remission, clinical response, endoscopic improvement, and CS-free remission. Safety was evaluated for all 823 patients who entered the OLE from the TRUE NORTH parent study. The mean exposure to ZEPOSIA through the OLE was 2.7 years.4-7
UC Study 1 (10-week induction): 645 patients were randomized 2:1 to either ZEPOSIA 0.92 mg given orally once daily or placebo for 10 weeks, beginning with a dosage titration. The trial included patients who had an inadequate response or were intolerant to any of the following: oral aminosalicylates, corticosteroids, immunomodulators, or a biologic. Patients were required to be on stable doses of oral aminosalicylates and/or corticosteroids.1
UC Study 2 (42-week maintenance): 457 patients who received ZEPOSIA in either UC Study 1 or in an open-label arm and achieved clinical response at Week 10 were re-randomized 1:1 and were treated with either ZEPOSIA 0.92 mg (n=230) or placebo (n=227) for 42 weeks (UC Study 2), for a total of 52 weeks of treatment.1
CS=corticosteroid; OLE=open-label extension; RBS=rectal bleeding subscore; UC=ulcerative colitis.
3-component Mayo score consisting of rectal bleeding subscore (RBS)=0, stool frequency subscore (SFS) 0 or 1 (and a decrease of ≥ 1 point from baseline SFS), and endoscopy subscore 0 or 1 without friability
A reduction from baseline in the 3-component Mayo score of ≥2 points and ≥35%, and a reduction from baseline in RBS of ≥1 point or an absolute RBS of 0 or 1
Mayo endoscopy subscore of 0 or 1 point without friability
Endoscopic-Histologic Mucosal Improvement
Mayo endoscopy subscore of 0 or 1 without friability and histologic improvement of colonic tissue (defined as no neutrophils in the epithelial crypts or lamina propria and no increase in eosinophils, no crypt destruction, and no erosions, ulcerations, or granulation tissue, ie, Geboes <2.0)
CS-free Clinical Remission
Clinical remission at Week 52 while off corticosteroids for ≥12 weeks
Among the patients considered for the UC studies, 98.8% (2152/2178) passed protocol-defined preexisting cardiac disorder screening8c
cIncludes UC Study 1 from the TRUE NORTH trial and the phase 2 TOUCHSTONE trial. ZEPOSIA was not studied in patients who had1,8:
CS=corticosteroid; QT=an extended interval between the heart contracting and relaxing; QTcF=corrected QT interval by Fridericia; RBS=rectal bleeding subscore; SFS=stool frequency subscore; TIA=transient ischemic attack.
At entry to UC Study 2 (maintenance), 35% of patients were in clinical remission; 29% of patients were on CS; and 31% of patients had an inadequate response, loss of response, or intolerance to TNFi.1
CS=corticosteroid; RBS=rectal bleeding subscore; TNFi=tumor necrosis factor inhibitor.
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