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Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis (ELEVATE UC 52)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03945188
Recruitment Status : Active, not recruiting
First Posted : May 10, 2019
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Arena Pharmaceuticals

Study Description
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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 Intervention/treatment Phase
Ulcerative Colitis Drug: Etrasimod Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
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 13, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Etrasimod 2 mg Drug: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment
Other Name: APD334
Placebo Comparator: Placebo Drug: Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub-scores [ Time Frame: Week 12 ]
  2. Proportion of Participants With 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 With Clinical Remission Assessed by Mayo Component Sub-scores and no Corticosteroid use for ≥ 12 Weeks [ Time Frame: Week 52 ]
  4. Proportion of Participants With Mucosal Healing Assessed by Geboes Index Scores [ Time Frame: Week 52 ]
  5. Proportion of Participants With Mucosal Healing Assessed by Geboes Index Scores [ Time Frame: Week 12 ]
  6. Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub-scores [ Time Frame: Week 12 and Week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years 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
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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): NCT03945188


Locations
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Sponsors and Collaborators
Arena Pharmaceuticals
Investigators
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Study Director: Arena CT.gov Administrator Arena Pharmaceuticals
More Information
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Additional Information:

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Responsible Party: Arena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03945188    
Other Study ID Numbers: APD334-301
2018-003985-15 ( EudraCT Number )
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arena Pharmaceuticals:
Ulcerative Colitis
Etrasimod
APD334
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