PF-07054894 for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+29 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Pfizer

Disqualifiers: Crohn's disease, Cancer, others

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Adults with moderate to severe ulcerative colitis (UC) extending beyond the rectum, who haven't responded well to conventional therapies, can join this trial. They must have had UC for at least 3 months and weigh over 88.2 pounds. People with recent major surgery or trauma, other bowel diseases like Crohn's, recent infections, or a history of colon cancer are excluded.

Inclusion Criteria

I have been diagnosed with moderate to severe ulcerative colitis for at least 3 months.

My disease affects areas more than 15 cm from the start of my large intestine.

Must have a 5 to 9 score on the modified mayo score, including an endoscopy subscore of at least 2

See 2 more

Exclusion Criteria

I have a history of certain colon conditions or cancer.

I had bowel surgery less than 6 months ago.

I have severe colon inflammation, liver bile duct inflammation, or abnormal growths in my colon.

See 2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oral PF-07054894 or a matched placebo for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

PF-07054894 (Unknown)
Placebo (Unknown)

Trial OverviewThe study is testing PF-07054894 against a placebo in adults with ulcerative colitis to see if it's safe and effective. Participants will be randomly assigned to receive either the experimental medication or a placebo without knowing which one they're getting.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment Group 1Experimental Treatment1 Intervention

Oral PF-07054894

Group II: Treatment Group 2Placebo Group1 Intervention

Matched Placebo