RecruitingPhase 2Phase 3NCT07363694

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

AN INTERVENTIONAL PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY-UNBLINDED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)


Sponsor

Pfizer

Enrollment

1,156 participants

Start Date

Feb 11, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 35 YearsMax Age: 80 Years

Inclusion Criteria4

  • Diagnosis of chronic obstructive pulmonary disease (COPD) for at least 12 months (based on Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] definition).
  • Spirometry values (post-bronchodilator forced expiratory volume in 1 second \[FEV1\]/forced vital capacity \[FVC\] less than \[<\] 70 percent (%) and post-bronchodilator FEV1 % predicted <70%, but greater than equal to 30%).
  • Continuous treatment with standard of care triple therapy of LABA + LAMA + ICS for ≥ 6 months prior to Screening Visit 1 and at a stable dose for ≥3 months
  • Documented history of at least 2 moderate or severe ECOPD within the last 12 months prior to Screening.

Exclusion Criteria4

  • Significant pulmonary disease other than COPD.
  • Requirement for continuous chronic treatment with oxygen at >4.0 liters / minute by nasal cannula or equivalent.
  • Hypoxemia with a resting SpO2 <88% while breathing ambient air (or on the participant's usual level of oxygen supplementation).
  • Clinically significant cardiovascular disease, acute and/or severe left heart failure, or heart failure partial ejection fraction, and/or cor pulmonale.

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Interventions

DRUGPF-07275315 dose 1

SC injection dose 1

DRUGPF-07275315-dose 2

SC injection dose 2

DRUGPlacebo

SC injection matched

DRUGPF-07275315-dose 3

SC injection dose 3


Locations(32)

SEC Clinical Research

Dothan, Alabama, United States

Pulmonary Associates of Mobile, P.C.

Mobile, Alabama, United States

Chandler Clinical Trials

Chandler, Arizona, United States

Pulmonary Associates, PA

Phoenix, Arizona, United States

IMAX Clinical Trials

La Palma, California, United States

NewportNativeMD, Inc.

Newport Beach, California, United States

California Medical Research Associates

Northridge, California, United States

Institute of HealthCare Assessment d/b/a Apex Clinical Research

San Diego, California, United States

Advanced Pulmonary Research Institute

Loxahatchee Groves, Florida, United States

Reed Medical Research

Miami, Florida, United States

Coastal Medical Research Institute, LLC

St. Petersburg, Florida, United States

Coastal Pulmonary and Critical Care, P.L.C

St. Petersburg, Florida, United States

Cpcc-Research Llc

East Point, Georgia, United States

Centricity Research Rincon Pulmonology

Rincon, Georgia, United States

ASHA Clinical Research - Munster, LLC

Hammond, Indiana, United States

Methodist Hospital Southlake

Merrillville, Indiana, United States

Paul A. Shapero, MD, PA

Bangor, Maine, United States

Revival Research Institute, LLC

Dearborn, Michigan, United States

Revive Research Institute, Inc.

Southfield, Michigan, United States

Henderson Clinical Trials

Henderson, Nevada, United States

Salem Chest Specialists

Winston-Salem, North Carolina, United States

Southeastern Research Center

Winston-Salem, North Carolina, United States

Toledo Institute of Clinical Research Inc.

Toledo, Ohio, United States

Clinical Research Associates of Central PA, LLC

DuBois, Pennsylvania, United States

Velocity Clinical Research, Gaffney

Gaffney, South Carolina, United States

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States

Velocity Clinical Research, Spartanburg

Spartanburg, South Carolina, United States

Health Concepts

Rapid City, South Dakota, United States

Premier Research Center, LLC

Hendersonville, Tennessee, United States

Sherman Clinical Research

Sherman, Texas, United States

Dr. Syed Anees Medicine Professional Corporation

Windsor, Ontario, Canada

Nishifukuoka Hospital

Fukuoka, Fukuoka, Japan

View Full Details on ClinicalTrials.gov

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NCT07363694


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