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

NCT05549323 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: C41510022022-501047-32-00
• Study Type: interventional
• Target: 44
• Locations: 3 countries
• Sites: 17

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.

Conditions

Ulcerative Colitis

Keywords

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (2)

• Part A: Proportion of participants achieving clinical remission at Week 12 in participants with moderate to severe UC.

  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

• Part B: Percent change from baseline in the mMS in participants with mild to moderate UC.

  Week 12

Secondary Outcomes (3)

• Part A: Proportion of participants achieving improvement in endoscopic appearance at Week 12

  Week 12

• Part A: Proportion of participants with clinical remission at Week 12

  Week 12

• Part B: Proportion of participants achieving clinical remission at Week 12

  Week 12

Study Arms (2)

Treatment Group 1

EXPERIMENTAL

Oral PF-07054894

Drug: PF-07054894

Treatment Group 2

PLACEBO COMPARATOR

Matched Placebo

Drug: Placebo

Interventions

PF-07054894 DRUG

Oral

Treatment Group 1

Placebo DRUG

Placebo

Treatment Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (17)

IHS Health Research

Kissimmee, Florida, 34741, United States

Location

Kissimmee Endosocpy Center ( Endoscopy Only )

Kissimmee, Florida, 34741, United States

Location

Orlando Diagnostic Center ( CXR Only )

Kissimmee, Florida, 34741, United States

Location

Tampa Bay Endoscopy Center

Tampa, Florida, 33603, United States

Location

GCP Clinical Research

Tampa, Florida, 33609, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Carta - Clinical Associates In Research Therapeutics Of America

San Antonio, Texas, 78212, United States

Location

Charité Research Organisation

Berlin, 10117, Germany

Location

Charité Universitaetsmedizin Berlin - Campus Mitte

Berlin, 10117, Germany

Location

NZOZ Centrum Medyczne KERmed

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-231, Poland

Location

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, Lesser Poland Voivodeship, 30-688, Poland

Location

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

Warsaw, Masovian Voivodeship, 04-501, Poland

Location

KLIMED Marek Klimkiewicz

Bialystok, Podlaskie Voivodeship, 15-704, Poland

Location

MZ Badania Slowik Zymla Spolka Jawna

Knurów, Silesian Voivodeship, 44-190, Poland

Location

NZOZ Twoje Zdrowie EL Sp. z o. o.

Elblag, Warmian-Masurian Voivodeship, 82-300, Poland

Location

Centrum Medyczne Med-Gastr

Lodz, 91-034, Poland

Location

IRMED

Piotrkow Trybunalski, Łódź Voivodeship, 97-300, Poland

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of the two groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: September 22, 2022
• Study Start: November 7, 2022
• Primary Completion: November 11, 2025
• Study Completion: November 11, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); PL (8); US (7)