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

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

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.

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Placebo; Drug: PF-07054894

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité Universitaetsmedizin Berlin - Campus Mitte
  • Berlin, Germany, 10117
    • Charité Research Organisation
• Poland
  • Lodz, Poland, 91-034
    • Centrum Medyczne Med-Gastr
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-231
      • NZOZ Centrum Medyczne KERmed
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-688
      • SP ZOZ Szpital Uniwersytecki w Krakowie
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 04-501
      • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-704
      • Klimed Marek Klimkiewicz
  • Silesian Voivodeship
    • Knurów, Silesian Voivodeship, Poland, 44-190
      • MZ Badania Slowik Zymla Spolka Jawna
  • Warmian-Masurian Voivodeship
    • Elblag, Warmian-Masurian Voivodeship, Poland, 82-300
      • NZOZ Twoje Zdrowie EL Sp. z o. o.
  • Łódź Voivodeship
    • Piotrkow Trybunalski, Łódź Voivodeship, Poland, 97-300
      • IRMED
• United States
  • Florida
    • Kissimmee, Florida, United States, 34741
      • IHS Health Research
    • Kissimmee, Florida, United States, 34741
      • Kissimmee Endosocpy Center ( Endoscopy Only )
    • Kissimmee, Florida, United States, 34741
      • Orlando Diagnostic Center ( CXR Only )
    • Tampa, Florida, United States, 33609
      • GCP Clinical Research
    • Tampa, Florida, United States, 33603
      • Tampa Bay Endoscopy Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Texas
    • San Antonio, Texas, United States, 78212
      • Carta - Clinical Associates In Research Therapeutics Of America

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion 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).

Part A (moderate to severe): Must have a 5 to 9 score on the modified mayo score, including an endoscopy subscore of at least 2. Part B (mild to moderate): Participants with mMS of 4 to 6, ES of ≥2 and RB score of ≥1

• 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group 1; Oral PF-07054894	Drug: PF-07054894; Oral
Placebo Comparator: Treatment Group 2; Matched Placebo	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Proportion of participants achieving clinical remission at Week 12 in participants with moderate to severe UC.	Clinical remission based on modified Mayo Score is defined as endoscopic subscore equal 0 or 1 (without friability), stool frequency subscore equal 0 or 1, and rectal bleeding subscore equal 0	Week 12
Part B: Percent change from baseline in the mMS in participants with mild to moderate UC.		Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Proportion of participants achieving improvement in endoscopic appearance at Week 12	Endoscopic improvement is defined as a Mayo endoscopic subscore of ≤1 (without friability)	Week 12
Part A: Proportion of participants with clinical remission at Week 12	Clinical Remission defined by Total Mayo Score ≤2 and no individual subscore >1 and rectal bleeding subscore of 0	Week 12
Part B: Proportion of participants achieving clinical remission at Week 12	Clinical Remission based on modified Mayo Score is defined as endoscopic subscore 0 or 1 (without friability), stool frequency subscore 0 or 1, and rectal bleeding subscore 0.	Week 12

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): November 11, 2025
• Study Completion (Actual): November 11, 2025

Study Registration Dates

• First Submitted: September 17, 2022
• First Submitted That Met QC Criteria: September 17, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases
• Other Study ID Numbers: C4151002; 2022-501047-32-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No