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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05549323
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Pfizer
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pfizer CT.gov Call Center
Principal Investigator Affiliation	Pfizer
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Germany, Poland, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Ulcerative Colitis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Treatment Group 1

Oral PF-07054894

Placebo Comparator: Treatment Group 2

Matched Placebo

Interventions

Drug: - PF-07054894

Oral

Drug: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

IHS Health Research, Kissimmee, Florida

Status

Recruiting

Address

IHS Health Research

Kissimmee, Florida, 34741

Site Contact

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