A study to assess the performance and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/01/022606

Enrollment

372

Registered

2020-01-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Etrasimod: 2-mg Film Coated Tablet, Oral, once daily, up to 52 weeks of treatment Control Intervention1: The placebo product is Placebo Matching tablet: oral, once daily, up to 52 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed with ulcerative colitis (UC) >= 3 months prior to screening Active UC confirmed by endoscopy

Exclusion criteria

Exclusion criteria: Severe extensive colitis Diagnosis of Crohns disease or indeterminate colitis or the presence or history of a fistula consistent with CD Diagnosis of microscopic colitis ischemic colitis or infectious colitis

Design outcomes

Primary

Measure	Time frame
Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub scores Time Frame Week 12Timepoint: Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub scores Time Frame Week 12	—

Secondary

Measure	Time frame
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 12Timepoint: 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	—

Measure

Time frame

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 12Timepoint: 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

—

Countries

Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Georgia, Germany, Hungary, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Mexico, Netherlands, Poland, Portugal, Republic of Korea, Republic of Moldova, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States of America

Contacts

Public ContactSuneela Thatte

IQVIA RDS (India) Private Limited

suneela.thatte@quintiles.com

Outcome results