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NCT05549323 | Recruiting | Ulcerative Colitis


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

Condition or disease

Ulcerative Colitis

Intervention/treatment

PF-07054894

Placebo

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 27 participants
Masking: Quadruple
Primary Purpose: Treatment
Official Title: A PHASE 1B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF ORAL PF-07054894 IN ADULT PARTICIPANTS AGED 18-75 YEARS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
Actual Study Start Date : November 7, 2022
Estimated Primary Completion Date : October 22, 2024
Estimated Study Completion Date : October 22, 2024
Arm Intervention/treatment

Experimental: Treatment Group 1

Oral PF-07054894

Drug: PF-07054894

Placebo Comparator: Treatment Group 2

Matched Placebo

Drug: Placebo

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Confirmed diagnosis of moderate to severe 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).
  • Must have a 5 to 9 score on the modified mayo score, including an endoscopy subscore of at least 2.
  • Must 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

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

Location Details


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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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, Florida

IHS Health Research

Kissimmee, Florida, United States, 34741

Recruiting

United States, Florida

Kissimmee Endosocpy Center ( Endoscopy Only )

Kissimmee, Florida, United States, 34741

Recruiting

United States, Florida

Orlando Diagnostic Center ( CXR Only )

Kissimmee, Florida, United States, 34741

Not yet recruiting

United States, Florida

University of Miami Hospital -Procedures

Miami, Florida, United States, 33136

Not yet recruiting

United States, Florida

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

Miami, Florida, United States, 33136

Recruiting

United States, Florida

GCP Clinical Research

Tampa, Florida, United States, 33609

Recruiting

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

Recruiting

United States, Maryland

Charter Radiology

Columbia, Maryland, United States, 21044

Recruiting

United States, Maryland

Cascades Endoscopy Center

Columbia, Maryland, United States, 21045

Recruiting

United States, Maryland

Gastro Center of Maryland, LLC

Columbia, Maryland, United States, 21045

Recruiting

United States, Texas

Carta - Clinical Associates In Research Therapeutics Of America

San Antonio, Texas, United States, 78212

Not yet recruiting

Germany, Baden-württemberg

Universitaetsklinikum Ulm

Ulm, Baden-württemberg, Germany, 89081

Not yet recruiting

Germany, Baden-württemberg

Universitätsklinikum Ulm

Ulm, Baden-württemberg, Germany, 89081

Recruiting

Germany, Kujawsko-pomorskie

Charité Research Organisation

Berlin, Kujawsko-pomorskie, Germany, 10117

Recruiting

Germany, Mazowieckie

Charité Universitaetsmedizin Berlin - Campus Mitte

Berlin, Mazowieckie, Germany, 10117

Recruiting

Poland, Mazowieckie

NZOZ Centrum Medyczne KERmed

Bydgoszcz, Mazowieckie, Poland, 85-231

Recruiting

Poland, Mazowieckie

WIP Warsaw IBD Point Profesor Kierkuś

Warsaw, Mazowieckie, Poland, 00-728

Recruiting

Poland, Małopolskie

Endoterapia PFG SP. Z O. O.

Warsaw, Małopolskie, Poland, 02-665

Recruiting

Poland, Podlaskie

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Podlaskie, Poland, 04-501

Recruiting

Poland, Podlaskie

SP ZOZ Szpital Uniwersytecki w Krakowie

Kraków, Podlaskie, Poland, 30-688

Recruiting

Poland, Warmińsko-mazurskie

KLIMED Marek Klimkiewicz

Bialystok, Warmińsko-mazurskie, Poland, 15-704

Not yet recruiting

Poland, Łódzkie

KLIMED Marek Klimkiewicz

Łomża, Łódzkie, Poland, 18-404

Recruiting

Poland, Śląskie

NZOZ Twoje Zdrowie EL Sp. z o. o.

Elblag, Śląskie, Poland, 82-300

Recruiting

Poland, Śląskie

Centrum Medyczne Med-Gastr

Lodz, Śląskie, Poland, 91-034

Not yet recruiting

Poland,

H-T Centrum Medyczne Endoterapia

Tychy, Poland, 43-100

Not yet recruiting

Poland,

H-T Centrum Medyczne

Tychy, Poland, 43-100

Recruiting

Poland,

IRMED

Piotrkow Trybunalski, Poland, 97-300

Recruiting

Poland,

MZ Badania Slowik Zymla Spolka Jawna

Knurów, Poland, 44-190

Not yet recruiting

Poland,

H-T Centrum Medyczne Endoterapia

Tychy, Poland, 43-100

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