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

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Clinical Remission Assessed by Mayo Component Sub <br/ ><br>scoresTimepoint: Time Frame Week: 12 <br/ ><br> Time Frame Week: 52

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Achieving Endoscopic <br/ ><br>Improvement Assessed by Mayo Component <br/ ><br>Sub scores Time Frame Week 52 <br/ ><br>Proportion of Participants Achieving Endoscopic <br/ ><br>Improvement Assessed by Mayo Component <br/ ><br>Sub scores Time Frame Week 12Timepoint: Proportion of participants With Clinical <br/ ><br>Remission Assessed by Mayo Component Sub <br/ ><br>scores and no Corticosteroid use for ? 12 Weeks <br/ ><br>Time Frame: Week 52 <br/ ><br>Proportion of Participants With Mucosal Healing <br/ ><br>Assessed by Geboes Index Scores Time Frame <br/ ><br>Week 52 <br/ ><br>Proportion of Participants With Mucosal Healing <br/ ><br>Assessed by Geboes Index Scores Time Frame <br/ ><br>Week 12 <br/ ><br>Proportion of Participants With Clinical <br/ ><br>Remission Assessed by Mayo Component Sub <br/ ><br>scores Time Frame Week 12 and Week 52

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