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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

Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date March 26, 2021
Actual Study Start Date  ICMJE June 13, 2019
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub-scores [ Time Frame: Week 12 ]
  • Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub-scores [ Time Frame: Week 52 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores [ Time Frame: Week 52 ]
  • Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores [ Time Frame: Week 12 ]
  • Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub-scores and no Corticosteroid use for ≥ 12 Weeks [ Time Frame: Week 52 ]
  • Proportion of Participants With Mucosal Healing Assessed by Geboes Index Scores [ Time Frame: Week 52 ]
  • Proportion of Participants With Mucosal Healing Assessed by Geboes Index Scores [ Time Frame: Week 12 ]
  • Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub-scores [ Time Frame: Week 12 and Week 52 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Drug: Etrasimod
    Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment
    Other Name: APD334
  • Drug: Placebo
    Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment
Study Arms  ICMJE
  • Experimental: Etrasimod 2 mg
    Intervention: Drug: Etrasimod
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 26, 2021)
433
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2019)
372
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belarus,   Belgium,   Bulgaria,   Canada,   Chile,   Croatia,   Czechia,   Denmark,   Estonia,   France,   Georgia,   Germany,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lebanon,   Lithuania,   Mexico,   Moldova, Republic of,   Netherlands,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Switzerland,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Colombia
 
Administrative Information
NCT Number  ICMJE NCT03945188
Other Study ID Numbers  ICMJE APD334-301
2018-003985-15 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arena Pharmaceuticals
Study Sponsor  ICMJE Arena Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Arena CT.gov Administrator Arena Pharmaceuticals
PRS Account Arena Pharmaceuticals
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP