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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT05549323

Run by

Pfizer

People needed

44

Starts

2022-11-07

Expected to finish

2025-11-11

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• 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
• Tampa Bay Endoscopy Center — Tampa, 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, Kuyavian-Pomeranian Voivodeship, Poland
• SP ZOZ Szpital Uniwersytecki w Krakowie — Krakow, Lesser Poland Voivodeship, Poland
• Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś — Warsaw, Masovian Voivodeship, Poland
• KLIMED Marek Klimkiewicz — Bialystok, Podlaskie Voivodeship, Poland
• MZ Badania Slowik Zymla Spolka Jawna — Knurów, Silesian Voivodeship, Poland
• NZOZ Twoje Zdrowie EL Sp. z o. o. — Elblag, Warmian-Masurian Voivodeship, Poland
• Centrum Medyczne Med-Gastr — Lodz, Poland
• IRMED — Piotrkow Trybunalski, Łódź Voivodeship, Poland

Full record on ClinicalTrials.gov

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