TERMINATED

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

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Conditions

Ulcerative ColitisInflammatory Bowel Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A PHASE 1B, TWO-PART, 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 MILD TO SEVERE ULCERATIVE COLITIS

Quick Facts

Study Start:2022-11-07
Study Completion:2025-11-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05549323

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of moderate to severe (Part A) or mild to moderate (Part B) UC for ≥3 months prior to baseline.
  2. * Active disease beyond the rectum (\>15 cm of active disease from the anal verge at the screening endoscopy).
  3. * Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.
  4. * Total body weight \>40 kg (88.2 lb).
  1. * Presence of indeterminate; microscopic; ischemic; infectious; radiation colitis; diverticular disease; Crohn's disease; colonic stricture; colonic obstruction/ resection; presence of cancer.
  2. * History of bowel surgery within 6 months prior to baseline.
  3. * 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.
  4. * Presence of clinical signs of fulminant colitis or toxic megacolon, primary sclerosing cholangitis and evidence of colonic dysplasia, adenomas or neoplasia.
  5. * Clinically significant infections within 6 months of baseline

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

IHS Health Research
Kissimmee, Florida, 34741
United States
Kissimmee Endosocpy Center ( Endoscopy Only )
Kissimmee, Florida, 34741
United States
Orlando Diagnostic Center ( CXR Only )
Kissimmee, Florida, 34741
United States
Tampa Bay Endoscopy Center
Tampa, Florida, 33603
United States
GCP Clinical Research
Tampa, Florida, 33609
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Carta - Clinical Associates In Research Therapeutics Of America
San Antonio, Texas, 78212
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-07
Study Completion Date2025-11-11

Study Record Updates

Study Start Date2022-11-07
Study Completion Date2025-11-11

Terms related to this study

Keywords Provided by Researchers

  • Inflammatory Bowel Disease

Additional Relevant MeSH Terms

  • Ulcerative Colitis