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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05549323
• Other study ID #: C4151002
• Secondary ID: 2022-501047-32-0
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 7, 2022
• Est. completion date: July 12, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. completion date: July 12, 2024
• Est. primary completion date: July 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• PF-07054894
Oral
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Charité Research Organisation	Berlin
Germany	Charité Universitaetsmedizin Berlin - Campus Mitte	Berlin
Germany	Universitaetsklinikum Ulm	Ulm	Baden-württemberg
Germany	Universitätsklinikum Ulm	Ulm	Baden-württemberg
Poland	KLIMED Marek Klimkiewicz	Bialystok	Podlaskie
Poland	NZOZ Centrum Medyczne KERmed	Bydgoszcz	Kujawsko-pomorskie
Poland	NZOZ Twoje Zdrowie EL Sp. z o. o.	Elblag	Warminsko-mazurskie
Poland	MZ Badania Slowik Zymla Spolka Jawna	Knurów	Slaskie
Poland	SP ZOZ Szpital Uniwersytecki w Krakowie	Kraków	Malopolskie
Poland	Centrum Medyczne Med-Gastr	Lodz
Poland	KLIMED Marek Klimkiewicz	Lomza	Podlaskie
Poland	IRMED	Piotrkow Trybunalski	Lódzkie
Poland	H-T Centrum Medyczne	Tychy
Poland	H-T Centrum Medyczne Endoterapia	Tychy	Slaskie
Poland	H-T Centrum Medyczne Endoterapia	Tychy
Poland	Endoterapia PFG SP. Z O. O.	Warsaw	Mazowieckie
Poland	Medical Network WIP Warsaw IBD Point Profesor Kierkus	Warsaw	Mazowieckie
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warsaw	Mazowieckie
United States	Cascades Endoscopy Center	Columbia	Maryland
United States	Charter Radiology	Columbia	Maryland
United States	Gastro Center of Maryland, LLC	Columbia	Maryland
United States	University of Iowa	Iowa City	Iowa
United States	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	University of Miami Hospital -Procedures	Miami	Florida
United States	University of Miami Hospitals and Clinics Crohn's and Colitis Center	Miami	Florida
United States	Carta - Clinical Associates In Research Therapeutics Of America	San Antonio	Texas
United States	GCP Clinical Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants achieving clinical remission at Week 12	Clinical remission based on modified Mayo Score is defined as endoscopic subscore equal 0 or 1 (without friability), stool frequency subscore equal 0 or 1, and rectal bleeding subscore equal 0	Week 12
Secondary	Proportion of participants achieving improvement in endoscopic appearance at Week 12	Endoscopic improvement is defined as a Mayo endoscopic subscore of =1 (without friability)	Week 12
Secondary	Proportion of participants with clinical remission at Week 12	Clinical Remission defined by Total Mayo Score =2 and no individual subscore >1 and rectal bleeding subscore of 0	Week 12

External Links

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