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

Primary Purpose

Moderately to Severely Active Ulcerative Colitis

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Etrasimod

Placebo

About this trial

This is an interventional treatment trial for Moderately to Severely Active Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A documented of diagnosis with UC at least 6 months prior to screening.
Have active UC extending proximal to the rectum confirmed on endoscopy (≥ 15 cm involved)

Exclusion Criteria:

Have severe extensive colitis
Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
Diagnosis of microscopic colitis, ischemic colitis, infection colitis or colonic mucosal dysplasia

Sites / Locations

The First Affiliated Hospital of Fourth Military Medical University, PLARecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Experimental: Etrasimod 2mg

Placebo Comparator: Placebo

Etrasimod 2mg (optional open-label extension period)

Arm Description

2mg/tablet, administratered orally, once daily

matching tablet, administratered orally, once daily

2mg/tablet, administratered orally, once daily

Outcomes

Primary Outcome Measures

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)

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

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

Secondary Outcome Measures

Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore

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)

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

Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore

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)

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

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)

Proportion of Subjects who achieve Symptomatic Remission over time

Symptomatic remission per paritial Mayo score, ranging from 0-6(normal to severe)

Full Information

NCT ID

NCT04176588

First Posted

November 22, 2019

Last Updated

November 25, 2019

Sponsor

Everstar Therapeutics Limited

1. Study Identification

Unique Protocol Identification Number

NCT04176588

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 10, 2019 (Actual)

Primary Completion Date

October 2022 (Anticipated)

Study Completion Date

November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Everstar Therapeutics Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Moderately to Severely Active Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

333 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Etrasimod 2mg

Arm Type

Experimental

Arm Description

2mg/tablet, administratered orally, once daily

Arm Title

Placebo Comparator: Placebo

Arm Type

Placebo Comparator

Arm Description

matching tablet, administratered orally, once daily

Arm Title

Etrasimod 2mg (optional open-label extension period)

Arm Type

Experimental

Arm Description

2mg/tablet, administratered orally, once daily

Intervention Type

Drug

Intervention Name(s)

Etrasimod

Intervention Description

Drug:Etrasimod Tablet other name:APD334

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Drug:placebo Tablet

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

induction period week 12

Title

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

Description

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

Time Frame

Maintenance period week 40

Secondary Outcome Measure Information:

Title

Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore

Description

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

Time Frame

induction period week 12

Title

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

Description

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

Time Frame

induction period Week 12

Title

Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore

Description

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

Time Frame

Maintenance period Week 40

Title

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

Description

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

Time Frame

Maintenance period Week 40

Title

Proportion of Subjects who achieve symptomatic response over time

Description

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

Time Frame

Open label treatment period up to 40 Weeks

Title

Proportion of Subjects who achieve Symptomatic Remission over time

Description

Symptomatic remission per paritial Mayo score, ranging from 0-6(normal to severe)

Time Frame

Open label treatment period up to 40 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A documented of diagnosis with UC at least 6 months prior to screening. Have active UC extending proximal to the rectum confirmed on endoscopy (≥ 15 cm involved) Exclusion Criteria: Have severe extensive colitis Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease Diagnosis of microscopic colitis, ischemic colitis, infection colitis or colonic mucosal dysplasia

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qionghui Qiu, Asso. Project Director

Phone

86 21 5250 8621

qionghui.qiu@everestmedicines.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kaichun Wu

Organizational Affiliation

The First Affiliated Hospital of Fourth Military Medical University, PLA

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Fourth Military Medical University, PLA

City

Xi'an

State/Province

Shanxi

ZIP/Postal Code

710032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kaichun Wu Wu

Phone

029-84771502

kaicwu@fmmu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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