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Currently, you can access the following clinical trials being conducted worldwide:

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in
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03945188

Recruitment Status Active, not recruiting

First Posted May 10, 2019

Last update posted April 30, 2021

Study Description

Brief 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.

  • Condition or Disease:Ulcerative Colitis
  • Intervention/Treatment: Drug: Etrasimod
    Drug: Placebo
  • Phase: Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 433 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment
  • Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: January 2022
  • Estimated Study Completion Date: February 2022
Arms and interventions
Arm Intervention/treatment
Experimental: Etrasimod 2 mg
Drug: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment
Placebo Comparator: Placebo
Drug: Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment
Outcome Measures
  • Primary Outcome Measures: 1. Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores [ Time Frame: Week 12 ]
  • 2. Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores [ Time Frame: Week 52 ]
  • Secondary Outcome Measures: 1. Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores [ Time Frame: Week 52 ]
  • 2. Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores [ Time Frame: Week 12 ]
  • 3. Proportion of Participants Achieving Symptomatic Remission Assessed by Mayo Component Sub-scores [ Time Frame: Week 52 ]
  • 4. Proportion of Participants Achieving Symptomatic Remission Assessed by Mayo Component Sub-scores [ Time Frame: Week 12 ]
  • 5. Proportion of Participants in Clinical Remission at Week 52 and who had not Been Receiving Corticosteroids for ≥ 12 Weeks Prior to Week 52 [ Time Frame: Week 52 ]
  • 6. Proportion of Participants With Mucosal Healing Assessed by Geboes Index Score and Mayo Component Sub-scores [ Time Frame: Week 52 ]
  • 7. Proportion of Participants With Mucosal Healing Assessed by Geboes Index Score and Mayo Component Sub-scores [ Time Frame: Week 12 ]
  • 8. Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores [ Time Frame: At both Week 12 and Week 52 ]
Eligibility Criteria
  • Ages Eligible for Study: 16 to 80 Years (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion criteria:

1. Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening

2. Active UC confirmed by endoscopy

Exclusion criteria:

1. Severe extensive colitis

2. Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history
of a fistula consistent with CD

3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Contacts and Locations
Contacts
Locations
Show 374 Study Locations
Sponsors and Collaborators

Arena Pharmaceuticals

Investigators

Study Director: Arena CT.gov Administrator Arena Pharmaceuticals

More Information
  • Responsible Party: Arena Pharmaceuticals
  • ClinicalTrials.gov Identifier: NCT03945188 History of Changes
  • Other Study ID Numbers: APD334-301, 2018-003985-15
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: April 30, 2021
  • Last Verified: April 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Arena Pharmaceuticals: Etrasimod
    APD334
    Ulcerative Colitis
  • Additional relevant MeSH terms: Colitis, Ulcerative
    Ulcer
    Colitis