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

Last updated: January 20, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

1

Condition

Crohn's Disease

Inflammatory Bowel Disease

Colic

Treatment

PF-07054894

Placebo

Clinical Study ID

NCT05549323
C4151002
2022-501047-32-00
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed diagnosis of moderate to severe (Part A) or mild to moderate (Part B) UCfor ≥3 months prior to baseline.

  • Active disease beyond the rectum (>15 cm of active disease from the anal verge atthe 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 leastone conventional therapy for UC.

  • Total body weight >40 kg (88.2 lb).

Exclusion

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 orconsidered in imminent need of surgery or with elective surgery scheduled to occurduring the study.

  • Presence of clinical signs of fulminant colitis or toxic megacolon, primarysclerosing cholangitis and evidence of colonic dysplasia, adenomas or neoplasia.

  • Clinically significant infections within 6 months of baseline

Study Design

Total Participants: 27
Treatment Group(s): 2
Primary Treatment: PF-07054894
Phase: 1
Study Start date:
November 07, 2022
Estimated Completion Date:
January 14, 2026

Connect with a study center

  • Universitaetsklinikum Ulm

    Ulm, Baden-württemberg 89081
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm, Baden-württemberg 89081
    Germany

    Site Not Available

  • Charité Research Organisation

    Berlin, 10117
    Germany

    Active - Recruiting

  • Charité Universitaetsmedizin Berlin - Campus Mitte

    Berlin, 10117
    Germany

    Active - Recruiting

  • NZOZ Centrum Medyczne KERmed

    Bydgoszcz, Kujawsko-pomorskie 85-231
    Poland

    Site Not Available

  • Endoterapia PFG SP. Z O. O.

    Warsaw, Mazowieckie 02-665
    Poland

    Active - Recruiting

  • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

    Warsaw, Mazowieckie 04-501
    Poland

    Active - Recruiting

  • Medical Network WIP Warsaw IBD Point Profesor Kierkuś

    Warsaw, Mazowieckie 04-501
    Poland

    Site Not Available

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, Mazowieckie 04-501
    Poland

    Active - Recruiting

  • WIP Warsaw IBD Point Profesor Kierkuś

    Warsaw, Mazowieckie 00-728
    Poland

    Active - Recruiting

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Kraków, Małopolskie 30-688
    Poland

    Active - Recruiting

  • KLIMED Marek Klimkiewicz

    Bialystok, Podlaskie 15-704
    Poland

    Active - Recruiting

  • KLIMED Marek Klimkiewicz

    Łomża, Podlaskie 18-404
    Poland

    Site Not Available

  • NZOZ Twoje Zdrowie EL Sp. z o. o.

    Elblag, Warmińsko-mazurskie 82-300
    Poland

    Site Not Available

  • IRMED

    Piotrkow Trybunalski, Łódzkie 97-300
    Poland

    Active - Recruiting

  • MZ Badania Slowik Zymla Spolka Jawna

    Knurów, Śląskie 44-190
    Poland

    Site Not Available

  • H-T Centrum Medyczne Endoterapia

    Tychy, Śląskie 43-100
    Poland

    Site Not Available

  • Centrum Medyczne Med-Gastr

    Lodz, 91-034
    Poland

    Site Not Available

  • H-T Centrum Medyczne

    Tychy, 43-100
    Poland

    Site Not Available

  • IHS Health Research

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Kissimmee Endosocpy Center ( Endoscopy Only )

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Orlando Diagnostic Center ( CXR Only )

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • University of Miami Hospital -Procedures

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Miami Hospitals and Clinics Crohn's and Colitis Center

    Miami, Florida 33136
    United States

    Site Not Available

  • GCP Clinical Research

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Cascades Endoscopy Center

    Columbia, Maryland 21045
    United States

    Active - Recruiting

  • Charter Radiology

    Columbia, Maryland 21044
    United States

    Active - Recruiting

  • Gastro Center of Maryland, LLC

    Columbia, Maryland 21045
    United States

    Site Not Available

  • Carta - Clinical Associates In Research Therapeutics Of America

    San Antonio, Texas 78212
    United States

    Site Not Available

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