Overview

A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis

Status:
Withdrawn

Trial end date:
2023-10-26

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to evaluate efficacy and safety of PF-06826647 in moderate to severe ulcerative colitis

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Criteria

Inclusion Criteria:

- Participants with moderate to severe UC as defined by a total Mayo score of ≥6, with a
rectal bleeding subscore of ≥1 and an endoscopic subscore of ≥2;

- Participants must have inadequate response to, loss of response to, or intolerance to
at least one conventional therapy for UC: Oral, intravascular, or intramuscular
corticosteroids; Immunosuppressants (azathioprine [AZA], 6-MP, or methotrexate [MTX]);
Anti-tumor necrosis factor (TNF) inhibitors (eg, infliximab, adalimumab, or
golimumab); Anti-integrin inhibitors (eg, vedolizumab); JAK inhibitor (eg,
tofacitinib); Anti-IL-12/IL-23 inhibitors (eg, ustekinumab).

Exclusion Criteria:

- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
colitis, radiation colitis, and diverticular disease associated with colitis, or
Crohn's disease

- Participants displaying clinical signs of fulminant colitis or toxic megacolon;

- Participants with evidence of colonic dysplasia, adenomas or neoplasia.