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

Pfizer

Status and phase: Enrolling; Phase 1

Conditions: Ulcerative Colitis

Treatments: Drug: PF-07054894; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05549323

C4151002

2022-501047-32-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

Treatment Group 1

Experimental group

Description:

Oral PF-07054894

Treatment:

Drug: PF-07054894

Treatment Group 2

Placebo Comparator group

Description:

Matched Placebo

Treatment:

Drug: Placebo