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

Phase 1

Recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: PF-07054894; Drug: Placebo

• Registration Number: NCT05549323
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-17
• Study First Submitted QC: 2022-09-17
• Study First Posted: 2022-09-22
• Study Start: 2022-11-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16
• Primary Completion: 2026-01-14
• Study Completion: 2026-01-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 1	PF-07054894	Oral PF-07054894
Treatment Group 2	Placebo	Matched Placebo

Primary Outcome Measures

Name	Time	Method
Part A: Proportion of participants achieving clinical remission at Week 12 in participants with moderate to severe UC.	Week 12	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
Part B: Percent change from baseline in the mMS in participants with mild to moderate UC.	Week 12

Secondary Outcome Measures

Name	Time	Method
Part A: Proportion of participants with clinical remission at Week 12	Week 12	Clinical Remission defined by Total Mayo Score ≤2 and no individual subscore \>1 and rectal bleeding subscore of 0
Part B: Proportion of participants achieving clinical remission at Week 12	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.
Part A: Proportion of participants achieving improvement in endoscopic appearance at Week 12	Week 12	Endoscopic improvement is defined as a Mayo endoscopic subscore of ≤1 (without friability)

Trial Locations

Locations (17)

IHS Health Research; 🇺🇸 Kissimmee, Florida, United States

Kissimmee Endosocpy Center ( Endoscopy Only ); 🇺🇸 Kissimmee, Florida, United States

Orlando Diagnostic Center ( CXR Only ); 🇺🇸 Kissimmee, Florida, United States

GCP Clinical Research; 🇺🇸 Tampa, Florida, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Carta - Clinical Associates In Research Therapeutics Of America; 🇺🇸 San Antonio, Texas, United States

Charité Research Organisation; 🇩🇪 Berlin, Germany

Charité Universitaetsmedizin Berlin - Campus Mitte; 🇩🇪 Berlin, Germany

NZOZ Centrum Medyczne KERmed; 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Endoterapia PFG SP. Z O. O.; 🇵🇱 Warsaw, Mazowieckie, Poland

Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś; 🇵🇱 Warsaw, Mazowieckie, Poland

SP ZOZ Szpital Uniwersytecki w Krakowie; 🇵🇱 Kraków, Małopolskie, Poland

KLIMED Marek Klimkiewicz; 🇵🇱 Bialystok, Podlaskie, Poland

NZOZ Twoje Zdrowie EL Sp. z o. o.; 🇵🇱 Elblag, Warmińsko-mazurskie, Poland

Centrum Medyczne Med-Gastr; 🇵🇱 Lodz, Poland

IRMED; 🇵🇱 Piotrkow Trybunalski, Łódzkie, Poland

MZ Badania Slowik Zymla Spolka Jawna; 🇵🇱 Knurów, Śląskie, Poland