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Study to Compare Oral PF-0665...

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

Last Updated: 2022-07-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

319 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-03

Study Completion Date

2021-05-10

Brief Summary

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

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-06651600 Drug Dose Level 1

Delivered orally for 8 weeks

Group Type EXPERIMENTAL

PF-06651600 or Placebo

Intervention Type DRUG

Delivered orally for 8 weeks.

PF-06651600 Drug Dose Level 2

Delivered orally for 8 weeks

Group Type EXPERIMENTAL

PF-06651600 or Placebo

Intervention Type DRUG

Delivered orally for 8 weeks.

PF-06651600 Drug Dose Level 3

Delivered orally for 8 weeks.

Group Type EXPERIMENTAL

PF-06651600 or Placebo

Intervention Type DRUG

Delivered orally for 8 weeks.

PF-06651600 Placebo

Delivered orally for 8 weeks.

Group Type PLACEBO_COMPARATOR

PF-06651600 or Placebo

Intervention Type DRUG

Delivered orally for 8 weeks.

PF-06700841 Drug Dose Level 1

Delivered orally for 8 weeks

Group Type EXPERIMENTAL

PF-06700841 or Placebo

Intervention Type DRUG

Delivered orally for 8 weeks.

PF-06700841 Drug Dose Level 2

Delivered orally for 8 weeks.

Group Type EXPERIMENTAL

PF-06700841 or Placebo

Intervention Type DRUG

Delivered orally for 8 weeks.

PF-06700841 Drug Dose Level 3

Delivered orally for 8 weeks.

Group Type EXPERIMENTAL

PF-06700841 or Placebo

Intervention Type DRUG

Delivered orally for 8 weeks.

PF-06700841 Placebo

Delivered orally for 8 weeks.

Group Type PLACEBO_COMPARATOR

PF-06700841 or Placebo

Intervention Type DRUG

Delivered orally for 8 weeks.

PF-06651600 Drug Dose Level 4

Delivered orally for 24 weeks.

Group Type EXPERIMENTAL

PF-06651600

Intervention Type DRUG

Delivered orally for 24 weeks.

PF-06700841 Drug Dose Level 4

Delivered orally for 24 weeks.

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

Delivered orally for 24 weeks.

Interventions

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PF-06651600 or Placebo

Delivered orally for 8 weeks.

Intervention Type DRUG

PF-06700841 or Placebo

Delivered orally for 8 weeks.

Intervention Type DRUG

PF-06700841

Delivered orally for 24 weeks.

Intervention Type DRUG

PF-06651600

Delivered orally for 24 weeks.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Dothan Surgery Center

Dothan, Alabama, United States

Site Status

Gut P.C., dba Digestive Health Specialists of the Southeast

Dothan, Alabama, United States

Site Status

Long Beach Clinical Trials Services Inc.

Long Beach, California, United States

Site Status

Southern California Research Institute Medical Group/West Gastroenterology Medical Group/Airport En-

Los Angeles, California, United States

Site Status

Clinical Application Laboratories, INC.

San Diego, California, United States

Site Status

San Diego Endoscopy Center

San Diego, California, United States

Site Status

Medical Associates Research Group

San Diego, California, United States

Site Status

Front Range Endoscopy Center

Colorado Springs, Colorado, United States

Site Status

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Site Status

Bristol Hospital

Bristol, Connecticut, United States

Site Status

Connecticut Clinical Research Institute

Bristol, Connecticut, United States

Site Status

Central Connecticut Endoscopy Center

Plainville, Connecticut, United States

Site Status

West Coast Endoscopy Center

Clearwater, Florida, United States

Site Status

University of Miami Hospital and Clinics

Miami, Florida, United States

Site Status

University of Miami Hospital

Miami, Florida, United States

Site Status

Millenia Surgery Center

Orlando, Florida, United States

Site Status

HMD Research LLC

Orlando, Florida, United States

Site Status

Orlando Gastroenterology, PA

Orlando, Florida, United States

Site Status

Southwest Gastroenterology

Oak Lawn, Illinois, United States

Site Status

Chevy Chase Endoscopy Center

Chevy Chase, Maryland, United States

Site Status

Feldman ENT

Chevy Chase, Maryland, United States

Site Status

MGG Group Co. Inc., Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Site Status

Cascades Endoscopy Center

Columbia, Maryland, United States

Site Status

Gastro Center of Maryland

Columbia, Maryland, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status