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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 March 2022
• Main ID: NCT03945188
• Date of registration: 08/05/2019
• Prospective Registration: Yes
• Primary sponsor: Arena Pharmaceuticals
• Public title: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis ELEVATE UC 52
• Scientific 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
• Date of first enrolment: June 13, 2019
• Target sample size: 433
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03945188
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, Colombia, 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

Contacts

• Name: Arena CT.gov Administrator
• Affiliation: Arena Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Etrasimod

Drug: Placebo

Primary Outcome(s)

Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores [Time Frame: Week 12]

Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores [Time Frame: Week 52]

Secondary Outcome(s)

Proportion of Participants With Mucosal Healing Assessed by Geboes Index Score and Mayo Component Sub-scores [Time Frame: Week 52]

Proportion of Participants With Mucosal Healing Assessed by Geboes Index Score and Mayo Component Sub-scores [Time Frame: Week 12]

Proportion of Participants Achieving Symptomatic Remission Assessed by Mayo Component Sub-scores [Time Frame: Week 12]

Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores [Time Frame: Week 52]

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]

Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores [Time Frame: At both Week 12 and Week 52]

Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores [Time Frame: Week 12]

Proportion of Participants Achieving Symptomatic Remission Assessed by Mayo Component Sub-scores [Time Frame: Week 52]

Secondary ID(s)

APD334-301

2018-003985-15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors