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

NCT05549323

TerminatedPhase 1

Sponsor: Pfizer

Conditions: Ulcerative Colitis

Interventions: PF-07054894, Placebo

Countries: United States, Germany, Poland

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (17)

Kissimmee, Florida, United States
Kissimmee, Florida, United States
Kissimmee, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Iowa City, Iowa, United States
San Antonio, Texas, United States
Berlin, Germany
Berlin, Germany
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Krakow, Lesser Poland Voivodeship, Poland
Warsaw, Masovian Voivodeship, Poland
Bialystok, Podlaskie Voivodeship, Poland
Knurów, Silesian Voivodeship, Poland
Elblag, Warmian-Masurian Voivodeship, Poland
Lodz, Poland
Piotrkow Trybunalski, Łódź Voivodeship, Poland