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

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ClinicalTrials.gov Identifier: NCT04176588
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Moderately to Severely Active Ulcerative Colitis Drug: Etrasimod Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 10, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Proportion of Subjects With Clinical Remission Assessed by modified Mayo score(mMS) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Open label treatment period up to 40 Weeks ]
    Symptomatic remission per paritial Mayo score, ranging from 0-6(normal to severe)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04176588


Contacts
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Contact: Qionghui Qiu, Asso. Project Director 86 21 5250 8621 qionghui.qiu@everestmedicines.com

Locations
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China, Shanxi
The First Affiliated Hospital of Fourth Military Medical University, PLA Recruiting
Xi'an, Shanxi, China, 710032
Contact: Kaichun Wu Wu    029-84771502    kaicwu@fmmu.edu.cn   
Sponsors and Collaborators
Everstar Therapeutics Limited
Investigators
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Principal Investigator: Kaichun Wu The First Affiliated Hospital of Fourth Military Medical University, PLA
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Responsible Party: Everstar Therapeutics Limited
ClinicalTrials.gov Identifier: NCT04176588    
Other Study ID Numbers: ES101002
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases