A Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis
NCT ID: NCT05549323
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
44 participants
INTERVENTIONAL
2022-11-07
2025-11-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment Group 1
Oral PF-07054894
PF-07054894
Oral
Treatment Group 2
Matched Placebo
Placebo
Placebo
Interventions
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PF-07054894
Oral
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2022-501047-32-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4151002
Identifier Type: -
Identifier Source: org_study_id
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