Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: PF-06700841; Drug: PF-06651600 or Placebo; Drug: PF-06700841 or Placebo; Drug: PF-06651600

Study type: Interventional

Funder types: Industry

Identifiers

NCT02958865

B7981005

2016-003708-29 (EudraCT Number)

VIBRATO (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.

Enrollment: 319 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of ulcerative colitis for greater than/equal to 3 months.
• Moderate to severe active ulcerative colitis
• Inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.

Exclusion criteria

• Pregnant or breastfeeding
• Clinical findings suggestive of Crohn's Disease
• History of bowel surgery within 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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319 participants in 10 patient groups, including a placebo group

PF-06651600 Drug Dose Level 1

Experimental group

Description:

Delivered orally for 8 weeks

Treatment:

Drug: PF-06651600 or Placebo

PF-06651600 Drug Dose Level 2

Experimental group

Description:

Delivered orally for 8 weeks

Treatment:

Drug: PF-06651600 or Placebo

PF-06651600 Drug Dose Level 3

Experimental group

Description:

Delivered orally for 8 weeks.

Treatment:

Drug: PF-06651600 or Placebo

PF-06651600 Placebo

Placebo Comparator group

Description:

Delivered orally for 8 weeks.

Treatment:

Drug: PF-06651600 or Placebo

PF-06700841 Drug Dose Level 1

Experimental group

Description:

Delivered orally for 8 weeks

Treatment:

Drug: PF-06700841 or Placebo

PF-06700841 Drug Dose Level 2

Experimental group

Description:

Delivered orally for 8 weeks.

Treatment:

Drug: PF-06700841 or Placebo

PF-06700841 Drug Dose Level 3

Experimental group

Description:

Delivered orally for 8 weeks.

Treatment:

Drug: PF-06700841 or Placebo

PF-06700841 Placebo

Placebo Comparator group

Description:

Delivered orally for 8 weeks.

Treatment:

Drug: PF-06700841 or Placebo

PF-06651600 Drug Dose Level 4

Experimental group

Description:

Delivered orally for 24 weeks.

Treatment:

Drug: PF-06651600

PF-06700841 Drug Dose Level 4

Experimental group

Description:

Delivered orally for 24 weeks.

Treatment:

Drug: PF-06700841