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Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

NCT03945188 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 433

Last updated 2022-12-20

Study results available
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Summary

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.

Conditions

Interventions

DRUG

Etrasimod

Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment

DRUG

Placebo

Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment

Sponsors & Collaborators

  • Arena Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Arena CT.gov Administrator · Arena Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-13
Primary Completion
2022-02-08
Completion
2022-02-16
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bulgaria
  • Canada
  • Chile
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • France
  • Georgia
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Latvia
  • Lebanon
  • Lithuania
  • Mexico
  • Moldova
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03945188 on ClinicalTrials.gov