PF-07275315 for COPD

(COPD Trial)

Not yet recruiting at 10 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Pfizer
Must be taking: LABA, LAMA, ICS
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new medicine, PF-07275315, to determine its safety and effectiveness for people with COPD, a lung condition that makes breathing difficult and affects daily life. Participants will receive either the study medicine or a placebo (a lookalike with no active ingredients) to compare outcomes. The trial seeks individuals who have had moderate-to-severe COPD for at least a year, have experienced frequent flare-ups, and are already on regular COPD medication. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for COPD.

Will I have to stop taking my current medications?

The trial requires that you continue taking your regular COPD maintenance treatments at a stable dose for at least 3 months before joining. So, you will not need to stop your current medications.

Is there any evidence suggesting that PF-07275315 is likely to be safe for humans?

Research has shown that PF-07275315 has been promising in earlier studies for other conditions, suggesting it is generally safe. Although detailed information about side effects in COPD patients is not available, the trial's later phase indicates that earlier studies did not find major safety issues.

Treatments reaching this stage have typically been well-tolerated in earlier phases, with side effects likely being mild or moderate. Researchers will closely monitor participants taking PF-07275315 to ensure their safety and to identify any side effects.12345

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

Most treatments for COPD, like bronchodilators and corticosteroids, focus on managing symptoms by relaxing airways or reducing inflammation. But PF-07275315 is different because it targets the underlying biological pathways involved in COPD, potentially offering a more direct intervention at the disease's core. Researchers are excited about PF-07275315 because it could modify the disease process itself, rather than just alleviating symptoms. This new approach might lead to better long-term outcomes for patients, offering hope for a more effective treatment strategy.

What evidence suggests that PF-07275315 might be an effective treatment for COPD?

Research has shown that PF-07275315, which participants in this trial may receive, might help people with COPD (chronic obstructive pulmonary disease) breathe more easily. Early findings suggest this treatment reduces lung swelling, a major cause of COPD symptoms. Previous patients demonstrated better lung function and fewer flare-ups. While these early results are promising, more research is needed to confirm the effectiveness of PF-07275315 for COPD.12346

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for people aged 35-80 with moderate to severe COPD, who've had it for at least a year and have been on stable doses of standard treatments for the last 6 months. They should also have had at least two flare-ups in the past year.

Inclusion Criteria

My lung function tests show moderate to severe restriction.
I have been diagnosed with COPD for at least a year.
I have been on a stable dose of LABA, LAMA, and ICS for at least 3 months.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 2 Treatment

Participants receive PF-07275315 or placebo as multiple shots over 24 weeks

24 weeks
11 visits at the study clinic

Phase 3 Treatment

Participants receive PF-07275315 or placebo as multiple shots over 52 weeks

52 weeks
18 visits at the study clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • PF-07275315

Trial Overview

The study tests PF-07275315's effects and safety as a potential COPD treatment. Participants will receive either this medication or a placebo through shots over up to 52 weeks, with regular clinic visits to monitor progress.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Placebo Group

Group I: Phase 3 Treatment Arm AExperimental Treatment1 Intervention
Group II: Phase 2 Treatment Arm BExperimental Treatment1 Intervention
Group III: Phase 2 Treatment Arm AExperimental Treatment1 Intervention
Group IV: Phase 3 Treatment Arm BPlacebo Group1 Intervention
Group V: Phase 2 Treatment Arm CPlacebo Group1 Intervention

Find a Clinic Near You

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 profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

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The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) for the potential treatment of moderate- ...