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

Disqualifiers: Significant pulmonary disease, Hypoxemia, Cardiovascular disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 29

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this clinical trial is to learn about the effects and safety of the study medicine PF-07275315 for the potential treatment of COPD. COPD is a condition that makes it difficult to breathe, which negatively impacts the quality of life and functioning of people who are affected.

This study is seeking participants who:

* Are 35 to 80 years old

* Have had moderate-to-severe COPD for at least 12 months

* Have a documented history of at least 2 moderate or severe exacerbations within the last 12 months

* Have been continuously taking their regular maintenance treatment(s) for COPD over at least 6 months at a stable dose for 3 months

All participants will receive PF-07275315 or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied.

PF-07275315 or placebo will be given as multiple shots in the clinic over the course of 24 weeks for the Phase 2 part and 52 weeks for the Phase 3 part. We will compare the results of people receiving PF-07275315 to those of the people who do not. This will help us determine if PF-07275315 is safe and effective.

Participants who will be involved in the Phase 2 part of the study for about 40 weeks. During this time, they will have 11 visits at the study clinic.

Participants who will be involved in the Phase 3 part of the study for about 68 weeks. During this time, they will have 18 visits at the study clinic.

Who Is on the Research Team?

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.

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?

Group I: Phase 3 Treatment Arm A Experimental Treatment 1 Intervention

Group II: Phase 2 Treatment Arm B Experimental Treatment 1 Intervention

Group III: Phase 2 Treatment Arm A Experimental Treatment 1 Intervention

Group IV: Phase 3 Treatment Arm B Placebo Group 1 Intervention

Group V: Phase 2 Treatment Arm C Placebo Group 1 Intervention

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