NCT04176588

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
341

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

4.8 years

First QC Date

November 22, 2019

Last Update Submit

January 8, 2024

Conditions

Moderately to Severely Active Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore

    induction period week 12

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

    induction period Week 12

  • Proportion of Subjects Achieving Endoscopic Improvement Assessed by endoscopic subscore

    Maintenance period Week 40

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

    Maintenance period Week 40

  • Proportion of Subjects who achieve symptomatic response over time

    Open label treatment period up to 40 Weeks

  • +1 more secondary outcomes

Study Arms (3)

Experimental: Etrasimod 2mg

EXPERIMENTAL

2mg/tablet, administratered orally, once daily

Drug: Etrasimod

Placebo Comparator: Placebo

PLACEBO COMPARATOR

matching tablet, administratered orally, once daily

Drug: Placebo

Etrasimod 2mg (optional open-label extension period)

EXPERIMENTAL

2mg/tablet, administratered orally, once daily

Drug: Etrasimod

Interventions

EtrasimodDRUG

Drug:Etrasimod Tablet other name:APD334

Etrasimod 2mg (optional open-label extension period)Experimental: Etrasimod 2mg
PlaceboDRUG

Drug:placebo Tablet

Placebo Comparator: Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A documented of diagnosis with UC at least 3 months prior to screening.
  • Have active UC confirmed by endoscopy with ≥ 10 cm rectal involved.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Fourth Military Medical University, PLA

Xi’an, Shanxi, 710032, China

Location

Related Publications (2)

  • Wu K, Zheng C, Cao Q, Ding Y, Gao X, Zhong J, Chiu CT, Zhang H, Wang X, Wang B, Liang J, Liu X, Zhou Y, Xu B, Kim TO, Shen X, Chen D, Chen W, Liu Y, Shen J, Liu F, Ding X, Zhan Q, Chou JW, Zeng S, Lin Y, Ying L, Chen X; ENLIGHT UC Study Group. Etrasimod as induction and maintenance treatment for patients with moderately to severely active ulcerative colitis in East Asia (ENLIGHT UC): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. Lancet Gastroenterol Hepatol. 2025 Dec;10(12):1089-1103. doi: 10.1016/S2468-1253(25)00198-0. Epub 2025 Sep 30.

    PMID: 41043449DERIVED

  • Vermeire S, Rubin DT, Peyrin-Biroulet L, Dubinsky MC, Regueiro M, Irving PM, Goetsch M, Lazin K, Gu G, Wu J, Modesto I, McDonnell A, Guo X, Green J, Dalam AB, Yarur AJ. Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis. BMJ Open Gastroenterol. 2025 Jan 8;12(1):e001516. doi: 10.1136/bmjgast-2024-001516.

    PMID: 39778975DERIVED

MeSH Terms

Interventions

etrasimod

Study Officials

  • Kaichun Wu

    The First Affiliated Hospital of Fourth Military Medical University, PLA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2019

First Posted

November 25, 2019

Study Start

September 10, 2019

Primary Completion

July 1, 2024

Study Completion

October 1, 2024

Last Updated

January 9, 2024

Record last verified: 2024-01

Locations

CN(1)