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

• Status: Not yet recruiting
• Trial end date: 2024-11-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

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