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

Moderately to Severely Active Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04176588
• Other study ID #: ES101002
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 10, 2019
• Est. completion date: October 2024

Study information

• Verified date: January 2024
• Source: Everstar Therapeutics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 341
• Est. completion date: October 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Moderately to Severely Active Ulcerative Colitis
• Ulcer

Intervention

Drug:
• Etrasimod
Drug:Etrasimod Tablet other name:APD334
• Placebo
Drug:placebo Tablet

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Fourth Military Medical University, PLA	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Everstar Therapeutics Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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