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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
Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy)
Total body weight >40 kg (88.2 lb)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My disease affects areas more than 15 cm from the start of my large intestine.
Select...
I weigh more than 88.2 pounds.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of participants achieving clinical remission at Week 12
Secondary outcome measures
Proportion of participants achieving improvement in endoscopic appearance at Week 12
Proportion of participants with 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
4,562 Previous Clinical Trials
10,907,099 Total Patients Enrolled
32 Trials studying Ulcerative Colitis
425,990 Patients Enrolled for Ulcerative Colitis
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,471 Previous Clinical Trials
8,088,490 Total Patients Enrolled
26 Trials studying Ulcerative Colitis
11,911 Patients Enrolled for Ulcerative Colitis

Media Library

PF-07054894 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05549323 — Phase 1
Ulcerative Colitis Research Study Groups: Treatment Group 1, Treatment Group 2
Ulcerative 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Treatment Group 1 received the FDA's stamp of approval?

"Treatment Group 1's safety level was determined to be a 1 due to the limited clinical evidence gathered during Phase I of this trial."

Answered by AI

How many individuals have been included in the research so far?

"This research endeavours to recruit 27 suitable individuals that meet the criteria for inclusion. Locations where this study is being conducted include IHS Health Research in Kissimmee, Florida and Orlando Diagnostic Center (CXR Only) in Columbia, Maryland."

Answered by AI

Are individuals above the age of majority able to participate in this scientific experiment?

"The current study is seeking patients between the ages of 18 and 75. There are 70 studies that cater to participants under 18, while 347 trials target individuals over 65 years old."

Answered by AI

Could I potentially become a participant in this research project?

"This clinical trial seeks to enrol 27 individuals with ulcerative colitis, between the ages of 18 and 75. In order to qualify for this study, participants must demonstrate an active form of the disease that extends beyond 15 cm from the anal verge at screening endoscopy; have had inadequate response or intolerance to a prior conventional remedy; weigh more than 40 kg (88.2 lbs); be diagnosed with moderate-to-severe UC no less than 3 months before baseline; and receive a score ranging from 5 - 9 on the modified Mayo Score, which includes an endoscopy subscore equal to or greater than 2."

Answered by AI

Has sign-up for this clinical experiment opened yet?

"According to the clinicaltrials.gov website, this medical trial is still recruiting patients for participation. This experiment was posted on November 7th 2022 and has been updated as late as November 17th of that same year."

Answered by AI
~7 spots leftby Oct 2024