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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Participants are assigned to one of the two groups in parallel for the duration of the study.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Actual Study Start Date :
November 7, 2022
Estimated Primary Completion Date :
October 22, 2024
Estimated Study Completion Date :
October 22, 2024
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Confirmed diagnosis of moderate to severe 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 a 5 to 9 score on the modified mayo score, including an endoscopy subscore of at least 2.
Must 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
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.: