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

• Sponsor: Everstar Therapeutics Limited (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04176588
• Collaborator: (none)
• Enrollment: 333
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 37.7
• Patients Per Site Per Month: 8.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Moderately to Severely Active Ulcerative Colitis	Drug: Etrasimod; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 333 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 10, 2019
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of Subjects With Clinical Remission Assessed by modified Mayo score(mMS) [induction period week 12]

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

2. 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

1. Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore [induction period week 12]

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

2. Proportion of Subjects with Clinical Response Assessed by modified Mayo score(mMS) [induction period Week 12]

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

3. 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)

4. 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)

5. 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)

6. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. A documented of diagnosis with UC at least 6 months prior to screening.

2. Have active UC extending proximal to the rectum confirmed on endoscopy (≥ 15 cm 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Fourth Military Medical University, PLA	Xi'an	Shanxi	China	710032

Sponsors and Collaborators

• Everstar Therapeutics Limited

Investigators

• Principal Investigator: Kaichun Wu, The First Affiliated Hospital of Fourth Military Medical University, PLA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Everstar Therapeutics Limited
• ClinicalTrials.gov Identifier: NCT04176588
• Other Study ID Numbers: ES101002
• First Posted: Nov 25, 2019
• Last Update Posted: Nov 27, 2019
• Last Verified: Nov 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Ulcer

Study Results

No Results Posted as of Nov 27, 2019