For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Confirmed diagnosis of moderate to severe (Part A) or mild to moderate (Part B) UC for ≥3 months prior to baseline.
  2. 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


  1. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.
  2. Total body weight >40 kg (88.2 lb).

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Presence of indeterminate; microscopic; ischemic; infectious; radiation colitis; diverticular disease; Crohn's disease; colonic stricture; colonic obstruction/ resection; presence of cancer.
  2. History of bowel surgery within 6 months prior to baseline.
  3. 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.
  4. Presence of clinical signs of fulminant colitis or toxic megacolon, primary sclerosing cholangitis and evidence of colonic dysplasia, adenomas or neoplasia.
  5. Clinically significant infections within 6 months of baseline

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-800-718-1021Email iconEmail Study Center

Study Details


Contition

Ulcerative Colitis

Age

18 - 75

Phase

PHASE1

Participants Needed

27

Est. Completion Date

Jan 14, 2026

Treatment Type

INTERVENTIONAL


Sponsor

Pfizer

ClinicalTrials.gov NCT Identifier

NCT05549323

Study Number

C4151002

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