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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
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
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Who is running the clinical trial?
PfizerLead Sponsor
4,651 Previous Clinical Trials
17,742,686 Total Patients Enrolled
40 Trials studying Colitis
10,402 Patients Enrolled for Colitis
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,538 Previous Clinical Trials
14,913,863 Total Patients Enrolled
32 Trials studying Colitis
9,853 Patients Enrolled for Colitis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with moderate to severe ulcerative colitis for at least 3 months.I have a history of certain colon conditions or cancer.I had bowel surgery less than 6 months ago.My disease affects areas more than 15 cm from the start of my large intestine.I have severe colon inflammation, liver bile duct inflammation, or abnormal growths in my colon.I weigh more than 88.2 pounds.I have tried at least one standard treatment for UC without success.I have not had any serious infections in the last 6 months.I haven't had major surgery or significant injury in the last 4 weeks and don't need or plan any surgery during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group 1
- Group 2: Treatment Group 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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