Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02447302
• Date of registration: 13/05/2015
• Prospective Registration: Yes
• Primary sponsor: Arena Pharmaceuticals
• Public title: Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis
• Scientific title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients With Moderately to Severely Active Ulcerative Colitis
• Date of first enrolment: July 2015
• Target sample size: 156
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02447302
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Canada, Czechia, France, Germany, Hungary, Israel, Korea, Republic of, Latvia, Lithuania, New Zealand, Poland, Romania, Russian Federation, Spain, Ukraine, United Kingdom, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic
score

- Evidence of colonic ulcerative colitis activity on endoscopy

Exclusion Criteria:

- Within 30 days prior to randomization, receipt of any of the following for the
treatment of underlying disease: Non-biologic therapies (eg, cyclosporine, tacrolimus,
tofacitinib, thalidomide), a non-biologic investigational therapy or an approved
non-biologic therapy in an investigational protocol

- Within 60 days prior to randomization, receipt of any of the following: Infliximab,
adalimumab, golimumab, certolizumab or any other investigational or approved biologic
agent

- Any prior exposure to natalizumab, efalizumab, or rituximab



Age minimum: 18 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)

The effect of treatment with etrasimod (APD334) in improving the 3-component Mayo Clinic Score [Time Frame: Week 12]

Secondary Outcome(s)

The effect of treatment with etrasimod (APD334) in improving the 2-component Mayo Clinic Score [Time Frame: Week 12]

The effect of treatment with etrasimod (APD334) in improving the Total Mayo Clinic Score [Time Frame: Week 12]

The effect of treatment with etrasimod (APD334) on endoscopic improvement [Time Frame: Week 12]

Secondary ID(s)

APD334-003

2015-001942-28

Source(s) of Monetary Support

Please refer to primary and secondary sponsors