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

Pfizer

Status and phase: Withdrawn; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: PF-6826647 400 mg QD; Drug: PF-06826647 100 mg QD; Drug: PF-06826647 300 mg QD; Drug: Placebo; Drug: PF-06826647 600 mg QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT04209556

C2501003

2019-003999-39 (EudraCT Number)

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

PF-06826647 100 mg once a day (QD)

Experimental group

Description:

PF-06826647 100 mg once a day (QD)

Treatment:

Drug: PF-06826647 100 mg QD

PF-06826647 300 mg QD

Experimental group

Description:

PF-06826647 300 mg QD

Treatment:

Drug: PF-06826647 300 mg QD

PF-06826647 600 mg QD

Experimental group

Description:

PF-06826647 600 mg QD

Treatment:

Drug: PF-06826647 600 mg QD

Open Label Extension, PF-06826647 400 mg QD

Experimental group

Description:

PF-06826647 400 mg QD

Treatment:

Drug: PF-6826647 400 mg QD