A Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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).
EXCLUSION CRITERIA
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
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.
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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