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

• ClinicalTrials.gov Identifier: NCT03945188
• Recruitment Status: Active, not recruiting
• First Posted: May 10, 2019
• Last Update Posted: March 26, 2021
• Sponsor: Arena Pharmaceuticals
• Information provided by (Responsible Party): Arena Pharmaceuticals

Tracking Information

• First Submitted Date: May 8, 2019
• First Posted Date: May 10, 2019
• Last Update Posted Date: March 26, 2021
• Actual Study Start Date: June 13, 2019
• Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Ulcerative Colitis

Intervention

• 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

• Experimental: Etrasimod 2 mg
  Intervention: Drug: Etrasimod
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 26, 2021): 433
• Original Estimated Enrollment (submitted: May 8, 2019): 372
• Estimated Study Completion Date: January 2022
• Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 80 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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: NCT03945188
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Arena Pharmaceuticals
• Study Sponsor: Arena Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Director: Arena CT.gov Administrator; Arena Pharmaceuticals

• PRS Account: Arena Pharmaceuticals
• Verification Date: March 2021