Have you or your loved ones been diagnosed with ulcerative colitis?

You may be eligible to participate in a ulcerative colitis clinical trial.

Have you or your loved ones been diagnosed with ulcerative colitis? You may be eligible to participate in a ulcerative colitis clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Ulcerative Colitis Clinical Trial

NCT03950232 | Phase 3 | Interventional

Have you or your loved ones been diagnosed with ulcerative colitis?

You may be eligible to participate in a ulcerative colitis clinical trial.

Have you or your loved ones been diagnosed with ulcerative colitis? You may be eligible to participate in a ulcerative colitis clinical trial.

Recruiting

Male & Female

16 - 80

Years old

This study is looking to recruit 900 Participants

The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).

Show me more details

Details for the study

Brief Title

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

Official Title

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

Brief Summary

The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).

Treatments and/or Procedures

Etrasimod

Etrasimod 2 mg tablet by mouth, once daily up to approximately 8 years or until marketing authorization is obtained in the participant's country, whichever comes first

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Number and Severity of Safety Measures

Safety as assessed by the evaluation of adverse events

Up to approximately 8 years

Secondary

Change From Baseline in Partial Mayo Score

The partial Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 non-invasive components (rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease.

Baseline, Week 52, Week 104, Week 156, Week 208 and Week 260

Secondary

Change From Baseline in the Total Mayo Score

The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 components (endoscopic score, rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease.

Baseline, Week 52, and Week 104

Study Criteria

Inclusion Criteria:

  -  Must have met the eligibility criteria and have been enrolled in the qualified Phase 2
     or 3 parent studies listed below or other qualified region-specific studies and meet
     the following additional criteria:

       1. Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210
          (NCT04607837) must have completed the Week 12 visit and have been assessed to
          have active UC that has not improved or has worsened from baseline or completed
          the Week 52 visit

       2. Participants previously enrolled in APD334-302 (NCT03996369) must have completed
          the Week 12 visit

Exclusion Criteria:

  -  If Investigator considers the participant to be unsuitable for any reason to
     participate in the Open-Label Extension study

  -  Experienced an adverse event that led to discontinuation from parent study