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

A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Etrasimod for Induction and Maintenance Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis

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 Overview

• Status: Active, not recruiting
• Conditions: Moderately to Severely Active Ulcerative Colitis
• Intervention / Treatment: Drug: Etrasimod; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 341
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Qionghui Qiu, Asso. Project Director; Phone Number: 86 21 5250 8621; Email: qionghui.qiu@everestmedicines.com

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • The First Affiliated Hospital of Fourth Military Medical University, PLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Etrasimod 2mg; 2mg/tablet, administratered orally, once daily	Drug: Etrasimod; Drug:Etrasimod Tablet other name:APD334
Placebo Comparator: Placebo Comparator: Placebo; matching tablet, administratered orally, once daily	Drug: Placebo; Drug:placebo Tablet
Experimental: Etrasimod 2mg (optional open-label extension period); 2mg/tablet, administratered orally, once daily	Drug: Etrasimod; Drug:Etrasimod Tablet other name:APD334

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	Maintenance period week 40

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore	Endoscopic improvement per endoscopy subscore, ranging from 0 to 3 (normal to severe)	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).	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)	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)	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)	Open label treatment period up to 40 Weeks
Proportion of Subjects who achieve Symptomatic Remission over time	Symptomatic remission per paritial Mayo score, ranging from 0-6(normal to severe)	Open label treatment period up to 40 Weeks

Collaborators and Investigators

• Sponsor: Everstar Therapeutics Limited
• Investigators: Principal Investigator: Kaichun Wu, The First Affiliated Hospital of Fourth Military Medical University, PLA

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: ES101002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No