A Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis

Description

This is a study to learn if the experimental medicine (called PF-07054894) is safe, effective, and how it is processed in adult people with ulcers in the colon.

Conditions

Ulcerative Colitis

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Study Overview

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Study Details

Study overview

This is a study to learn if the experimental medicine (called PF-07054894) is safe, effective, and how it is processed in adult people with ulcers in the colon.

A PHASE 1B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF ORAL PF-07054894 IN ADULT PARTICIPANTS AGED 18-75 YEARS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

A Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis

Condition
Ulcerative Colitis
Intervention / Treatment

-

Contacts and Locations

Kissimmee

IHS Health Research, Kissimmee, Florida, United States, 34741

Kissimmee

IHS Health Research, Kissimmee, Florida, United States, 34741

Kissimmee

Kissimmee Endosocpy Center ( Endoscopy Only ), Kissimmee, Florida, United States, 34741

Kissimmee

Orlando Diagnostic Center ( CXR Only ), Kissimmee, Florida, United States, 34741

Miami

University of Miami Hospital -Procedures, Miami, Florida, United States, 33136

Miami

University of Miami Hospitals and Clinics Crohn's and Colitis Center, Miami, Florida, United States, 33136

Tampa

GCP Clinical Research, Tampa, Florida, United States, 33609

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Columbia

Charter Radiology, Columbia, Maryland, United States, 21044

Columbia

Cascades Endoscopy Center, Columbia, Maryland, United States, 21045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Confirmed diagnosis of moderate to severe (Part A) or mild to moderate (Part B) UC for ≥3 months prior to baseline.
  • * Active disease beyond the rectum (\>15 cm of active disease from the anal verge at the screening endoscopy).
  • * Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.
  • * Total body weight \>40 kg (88.2 lb).
  • * Presence of indeterminate; microscopic; ischemic; infectious; radiation colitis; diverticular disease; Crohn's disease; colonic stricture; colonic obstruction/ resection; presence of cancer.
  • * History of bowel surgery within 6 months prior to baseline.
  • * History of significant trauma or major surgery within 4 weeks of screening or considered in imminent need of surgery or with elective surgery scheduled to occur during the study.
  • * Presence of clinical signs of fulminant colitis or toxic megacolon, primary sclerosing cholangitis and evidence of colonic dysplasia, adenomas or neoplasia.
  • * Clinically significant infections within 6 months of baseline

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2026-01-14