A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

PF-07275315 dose 1: SC injection dose 1

PF-07275315-dose 2: SC injection dose 2

Placebo: SC injection matched

PF-07275315-dose 3: SC injection dose 3

Study summary

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.

Eligibility

Primary outcome measure(s)

• Phase 2 part: Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24 — Baseline to Week 24
  FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 is obtained from spirometry.
• Phase 3 part: Annualized rate of moderate or severe ECOPD — Baseline to Week 52
  Exacerbation of Chronic Obstructive Pulmonary Disease (ECOPD) are sudden worsening of respiratory symptoms that significantly worsen lung function and quality of life.

Trial sites (120)

+ 80 more sites — see the full list on the official registry below.

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