PF-07054894 for Ulcerative Colitis

Not currently recruiting at 31 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: Crohn's disease, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral medication, PF-07054894, to determine its safety and effectiveness for people with colon ulcers, specifically those with ulcerative colitis (UC). Researchers aim to understand how this medicine works in individuals with moderate to severe or mild to moderate UC. Participants will receive either the experimental drug or a placebo (a pill with no active medicine). The trial seeks adults with UC who have had the condition for at least three months and have not responded well to other treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that PF-07054894 is likely to be safe for humans?

Researchers are currently conducting studies to determine the safety of PF-07054894 for people with ulcerative colitis, a condition that causes sores in the colon. As a Phase 1 study, the main goal is to assess the treatment's safety. Researchers closely monitor for any side effects or issues that might arise when participants take this experimental medicine.

Unfortunately, detailed information about how well participants handle PF-07054894 is limited. Because this is an early-phase trial, the focus remains on collecting safety information. If the treatment had been approved for other uses, more might be known about its safety. However, since that's not the case here, this study is essential for understanding the safety of PF-07054894 for people with ulcerative colitis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ulcerative colitis?

Unlike the standard treatments for ulcerative colitis, which often include anti-inflammatory drugs and immunosuppressants, PF-07054894 offers a novel approach by targeting specific pathways involved in the disease process. This oral medication is designed to modulate immune responses in a more targeted way, which could potentially reduce inflammation without broadly suppressing the immune system. Researchers are particularly excited about PF-07054894 because it represents a shift towards precision therapy, which may lead to fewer side effects and improved outcomes for patients.

What evidence suggests that PF-07054894 might be an effective treatment for ulcerative colitis?

Research has shown that PF-07054894, which participants in this trial may receive, could be a promising treatment for ulcerative colitis. This small molecule blocks a protein called CCR6, which contributes to inflammation. By blocking this protein, the treatment might reduce colon inflammation, potentially benefiting those with ulcerative colitis. Early studies indicate that PF-07054894 is effective and works well as an oral medication. Although human studies provide limited information, its ability to specifically target CCR6 suggests it could be a good option for managing symptoms of inflammatory bowel diseases like ulcerative colitis. ^{1 3 6 7 8}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• PF-07054894
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Group 1 Experimental Treatment 1 Intervention

Oral PF-07054894

Group II: Treatment Group 2 Placebo Group 1 Intervention

Matched Placebo

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05549323

NCT05549323 | A Study to Learn About the Safety, Effects ... 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.

2. withpower.com withpower.com/trial/phase-1-ulcer-9-2022-7a7a5

PF-07054894 for Ulcerative Colitis · Info for Participants 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.

3. pubs.acs.org pubs.acs.org/doi/10.1021/acs.jmedchem.5c01946

Discovery of PF-07054894, a Potent Squaramide-Based ... The resulting clinical candidate PF-07054894 (18l) is a potent, orally bioavailable CCR6 antagonist with high selectivity within the chemokine receptor family ...

4. synapse.patsnap.com synapse.patsnap.com/drug/0ba03ccd4327451d9eeb1e37e3ba726e

PF-07054894 PF-07054894 is a selective small molecule antagonist targeting CCR6 for clinical treatment of inflammatory bowel disease (IBD). This project is also part of a ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0022356524170486

A Novel C-C Chemoattractant Cytokine (Chemokine) ... These results suggest that PF-07054894 shows functional selectivity for CCR6 relative to CCR7 and CXCR2. Upon equilibration, its potency for CCR6-mediated ...

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/369985

A Study to Learn About the Safety, Effects and ... 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.

7. trial.medpath.com trial.medpath.com/clinical-trial/165145e53637246c/nct05549323-oral-pf-07054894-ulcerative-colitis

A Study to Learn About the Safety, Effects and ... - MedPath 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.

8. jpet.aspetjournals.org jpet.aspetjournals.org/article/S0022-3565(24)17048-6/fulltext

A Novel C-C Chemoattractant Cytokine (Chemokine) ... Cells were incubated with PF-07054894 for 30 min (data from Fig. 1A) or 20 hours (number of cells migrating in control: 4,600) prior to the chemotaxis assay.