An Open-Label Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis

An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/01/022607

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: Must have met the eligibility criteria and have been enrolled in one of the two phase studies (APD334-301 or APD334-302)and/or any other qualified region-specific studies and also meet the following additional criteria: A. Subjects previously enrolled in Study APD334-301 must have either: I. Completed the Week 12 visit and whose UC condition in the opinion of the Investigator has not improved or has worsened, compared with baseline (Week 0/Day 1), may be eligible to enroll provided their endoscopic score (ES) is >= 2 and they meet one of the following entry criteria • Rectal bleeding (RB) subscore >= 2 at 2 timepoints at least 7 days and no more than 14 days apart • RB + stool frequency (SF) subscore >= 4 at 2 timepoints at least 7 days and no more than 14 days apart • RB >= subscore >= 2 or RB +SF subscores >= 4 (in any order) at 2- timepoints at least 7 days, and no more than 14 days apart 2.Participants previously enrolled in APD334 302 must have completed the Week 12 visit

Exclusion criteria

Exclusion criteria: 1 If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study 2 Experienced an adverse event (AE) that led to discontinuation (except when such an event is related to UC flare) from parent study

Design outcomes

Primary

Measure	Time frame
Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub scoresTimepoint: Time Frame Week: 12 Time Frame Week: 52	—

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

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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.com912266774242

Outcome results