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Clinical Trial: the efficacy and safety of ZEPOSIA were evaluated in 2 multicenter, randomized, double-blind, placebo-controlled clinical studies (UC Study 1 [induction] and UC Study 2 [maintenance]) in adult patients with moderately to severely active ulcerative colitis, defined as a Mayo score of 6 to 12 at baseline.4

Primary Endpoint of Clinical Remission Is Defined as: 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.4

Secondary Endpoint of Clinical Response Is Defined as: a reduction from baseline in the 3-component Mayo score of ≥2 and ≥35%, and a reduction from baseline in the RBS of ≥1 or an absolute RBS of 0 or 1.4

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.4

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. Corticosteroid tapering was required upon entering this study for patients who were receiving corticosteroids during the induction period.4

5-ASAs=5-aminosalicylic acids; Ph=phase; S1P=sphingosine 1-phosphate; UC=ulcerative colitis.

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