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

Phase 3

Active, not recruiting

• Conditions: Moderately to Severely Active Ulcerative Colitis
• Interventions: Drug: Etrasimod; Drug: Placebo

• Registration Number: NCT04176588
• Lead Sponsor: Everstar Therapeutics Limited

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-10
• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-25
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09
• Primary Completion: 2024-07
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 341

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etrasimod 2mg (optional open-label extension period)	Etrasimod	2mg/tablet, administratered orally, once daily
Placebo Comparator: Placebo	Placebo	matching tablet, administratered orally, once daily
Experimental: Etrasimod 2mg	Etrasimod	2mg/tablet, administratered orally, once daily

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects With Clinical Remission Assessed by modified Mayo score(mMS)	Maintenance period week 40	Clinical remission per mMS, ranging from 0-9 (normal to severe)

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore	Maintenance period Week 40	Endoscopic improvement per endoscopy subscore, ranging from 0 to 3 (normal to severe)
Proportion of Subjects with Clinical Response Assessed by modified Mayo score(mMS)	Maintenance period Week 40	Clinical response per mMS, ranging from 0 to 9 (normal to severe)
Proportion of Subjects who achieve symptomatic response over time	Open label treatment period up to 40 Weeks	Symptomatic response per paritial Mayo score(rectal bleeding, stool frequency), ranging from 0-6(normal to severe)
Proportion of Subjects who achieve Symptomatic Remission over time	Open label treatment period up to 40 Weeks	Symptomatic remission per paritial Mayo score, ranging from 0-6(normal to severe)

Trial Locations

Locations (1)

The First Affiliated Hospital of Fourth Military Medical University, PLA; 🇨🇳 Xi'an, Shanxi, China