A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

Everstar Therapeutics Limited341 enrolled

Overview

The purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis. Condition or disease: Ulcerative Colitis Intervention/treatment: Drug: Etrasimod Drug: Placebo Phase: Phase 3

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

341

Conditions

Moderately to Severely Active Ulcerative Colitis

Interventions

EtrasimodDRUG

Drug:Etrasimod Tablet other name:APD334

PlaceboDRUG

Drug:placebo Tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. A documented of diagnosis with UC at least 3 months prior to screening. 2. Have active UC confirmed by endoscopy with ≥ 10 cm rectal involved. Exclusion Criteria: 1. Have severe extensive colitis 2. Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease 3. Diagnosis of microscopic colitis, ischemic colitis, infection colitis or colonic mucosal dysplasia

Locations (1)

The First Affiliated Hospital of Fourth Military Medical University, PLA

Xi’an, Shanxi, China

Outcomes

Primary Outcomes

Proportion of Subjects With Clinical Remission Assessed by modified Mayo score(mMS)

Clinical remission per mMS(endoscopy, rectal bleeding, stool frequency), ranging from 0-9 (normal to severe)

Time frame: induction period week 12

Proportion of Subjects With Clinical Remission Assessed by modified Mayo score(mMS)

Clinical remission per mMS, ranging from 0-9 (normal to severe)

Time frame: Maintenance period week 40

Secondary Outcomes

Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore

Endoscopic improvement per endoscopy subscore, ranging from 0 to 3 (normal to severe)

Time frame: induction period week 12

Proportion of Subjects with Clinical Response Assessed by modified Mayo score(mMS)

Clinical response per mMS, ranging from 0 to 9 (normal to severe).

Time frame: induction period Week 12

Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore

Endoscopic improvement per endoscopy subscore, ranging from 0 to 3 (normal to severe)

Time frame: Maintenance period Week 40

Proportion of Subjects with Clinical Response Assessed by modified Mayo score(mMS)

Clinical response per mMS, ranging from 0 to 9 (normal to severe)

Time frame: Maintenance period Week 40

Proportion of Subjects who achieve symptomatic response over time

Symptomatic response per paritial Mayo score(rectal bleeding, stool frequency), ranging from 0-6(normal to severe)

Data from ClinicalTrials.gov

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