An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis

IQVIA Services Japan K.K. ICCC:0 个研究点目标入组 131 人开始时间: 2021年1月13日最近更新: 2023年10月17日

适应症

试验速览

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•Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 and 3 parent studies including the 40 Week Treatment Study APD334 308 or the Dose Ranging Study APD334 203 and meet the additional criteria:
•a. Subjects previously enrolled in Study APD334-203 must have completed the Week 12 visit
•b. Subjects previously enrolled in Study APD334-308:
•I. Must have completed the Week 52 visit
•II. Whose UC condition in the opinion of the Investigator has not improved or has worsened, compared with baseline (Week 0/Day 1) of Study APD334 302 the subject may be eligible to enroll provided their ES is >= 2 and they meet one of the following entry criteria:
•- Rectal bleeding (RB) subscore >= 2 at 2 timepoints at least 7 days and no more than 14 days apart
•- RB + stool frequency (SF) subscore >= 4 at 2 timepoints at least 7 days and no more than 14 days apart
•- RB subscore >= 2 or RB + SF subscores >= 4 (in any order) at 2 timepoints at least 7 days and no more than 14 days apart
•Note: For subjects discontinuing prior to Week 52 of Study APD334 308, an endoscopic evaluation is required to confirm eligibility for the OLE. An endoscopy should be scheduled upon the appearance of UC symptoms but no more than 14 days after the second timepoint for entry criteria above. A proctosigmoidoscopy does not need to be repeated if performed within the last 4 weeks.

•If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
•Experienced an adverse event that led to discontinuation from one of the parent studies

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