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Unknown

PF-07054894 for Ulcerative Colitis

Phase 1
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12

Summary

This trial tests a new medicine to treat colon ulcers in adults, looking at safety, effectiveness, and how it's processed.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While specific side effects of PF-07054894 aren't listed here, common side effects for drugs treating UC may include headache, nausea, increased risk of infection, abdominal pain, and reactions at the injection site.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A: Proportion of participants achieving clinical remission at Week 12 in participants with moderate to severe UC.
Secondary study objectives
Part A: Proportion of participants achieving improvement in endoscopic appearance at Week 12
Part A: Proportion of participants with clinical remission at Week 12
Part B: Proportion of participants achieving clinical remission at Week 12

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-07054894
2020
Completed Phase 1
~90

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,660 Previous Clinical Trials
17,877,328 Total Patients Enrolled
40 Trials studying Colitis
10,404 Patients Enrolled for Colitis
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,545 Previous Clinical Trials
14,918,493 Total Patients Enrolled
32 Trials studying Colitis
9,855 Patients Enrolled for Colitis

Media Library

PF-07054894 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05549323 — Phase 1
Colitis Research Study Groups: Treatment Group 1, Treatment Group 2
Colitis Clinical Trial 2023: PF-07054894 Highlights & Side Effects. Trial Name: NCT05549323 — Phase 1
PF-07054894 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05549323 — Phase 1
~9 spots leftby Jan 2026