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Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis

NCT03996369 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2022-12-21

Study results available
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Summary

The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).

Conditions

Interventions

DRUG

Etrasimod

Etrasimod 2 mg tablet by mouth, once daily up to 12-Week Induction Treatment Period

DRUG

Placebo

Etrasimod matching placebo tablet by mouth, once daily up to 12-Week Induction Treatment Period

Sponsors & Collaborators

  • Arena Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Arena CT.gov Administrator · Arena Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2021-12-07
Completion
2021-12-07
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bulgaria
  • Canada
  • Chile
  • Colombia
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • France
  • Georgia
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Lebanon
  • Lithuania
  • Mexico
  • Moldova
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • 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 NCT03996369 on ClinicalTrials.gov