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

NCT07363694 · Pfizer
In plain English

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Official title
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)
About this study
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 criteria
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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.
Study design
Enrollment target: 1156 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-02-11
Estimated completion: 2031-01-16
Last updated: 2026-06-17
Interventions
Drug: PF-07275315 dose 1Drug: PF-07275315-dose 2Drug: PlaceboDrug: PF-07275315-dose 3
Primary outcomes
  • Phase 2 part: Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline to Week 24)
  • Phase 3 part: Annualized rate of moderate or severe ECOPD (Baseline to Week 52)
Sponsor
Pfizer · industry
Contacts & investigators
ContactPfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021
InvestigatorPfizer CT.gov Call Center · study_director, Pfizer
All locations (87)
University of Alabama at Birmingham Lung Health CenterRecruiting
Birmingham, Alabama, United States
SEC Clinical ResearchRecruiting
Dothan, Alabama, United States
Pulmonary Associates of Mobile, P.C.Recruiting
Mobile, Alabama, United States
Chandler Clinical TrialsNot Yet Recruiting
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Pulmonary Associates, PARecruiting
Phoenix, Arizona, United States
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NewportNativeMD, Inc.Recruiting
Newport Beach, California, United States
California Medical Research AssociatesRecruiting
Northridge, California, United States
Institute of HealthCare Assessment d/b/a Apex Clinical ResearchRecruiting
San Diego, California, United States
Finlay Medical ResearchRecruiting
Greenacres City, Florida, United States
Clinical Research Specialists LLCNot Yet Recruiting
Kissimmee, Florida, United States
Advanced Pulmonary Research InstituteRecruiting
Loxahatchee Groves, Florida, United States
Reed Medical ResearchRecruiting
Miami, Florida, United States
Renstar Medical ResearchRecruiting
Ocala, Florida, United States
HCA Florida Ocala Imaging CenterRecruiting
Ocala, Florida, United States
Ocala Lung and Critical Care AssociatesRecruiting
Ocala, Florida, United States
Coastal Medical Research Institute, LLCRecruiting
St. Petersburg, Florida, United States
Coastal Pulmonary and Critical Care, P.L.CRecruiting
St. Petersburg, Florida, United States
Clinical Site Partners, LLC dba Flourish ResearchRecruiting
Winter Park, Florida, United States
Cpcc-Research LlcRecruiting
East Point, Georgia, United States
Centricity Research Rincon PulmonologyRecruiting
Rincon, Georgia, United States
ASHA Clinical Research - Munster, LLCRecruiting
Hammond, Indiana, United States
Methodist Hospital SouthlakeRecruiting
Merrillville, Indiana, United States
Southern Clinical Research, LLCNot Yet Recruiting
Zachary, Louisiana, United States
Paul A. Shapero, MD, PANot Yet Recruiting
Bangor, Maine, United States
Revival Research Institute, LLCRecruiting
Dearborn, Michigan, United States
AA Medical Research CenterRecruiting
Flint, Michigan, United States
Revive Research Institute, Inc.Recruiting
Southfield, Michigan, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Barnes-Jewish Hospital Investigational Drug ServiceRecruiting
St Louis, Missouri, United States
Barnes-Jewish HospitalRecruiting
St Louis, Missouri, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Washington University School-Cardiovascular Imaging and Clinical Research Core LaboratoryRecruiting
St Louis, Missouri, United States
Henderson Clinical TrialsRecruiting
Henderson, Nevada, United States
Salem Chest SpecialistsRecruiting
Winston-Salem, North Carolina, United States
Southeastern Research CenterRecruiting
Winston-Salem, North Carolina, United States
Toledo Institute of Clinical Research Inc.Not Yet Recruiting
Toledo, Ohio, United States
Clinical Research Associates of Central PA, LLCRecruiting
DuBois, Pennsylvania, United States
Velocity Clinical Research, GaffneyRecruiting
Gaffney, South Carolina, United States
Clinical Research of Rock HillRecruiting
Rock Hill, South Carolina, United States
Velocity Clinical Research, SpartanburgRecruiting
Spartanburg, South Carolina, United States
Health ConceptsRecruiting
Rapid City, South Dakota, United States
Clinical Trials Center of Middle Tennessee, LLCRecruiting
Franklin, Tennessee, United States
Premier Research Center, LLCRecruiting
Hendersonville, Tennessee, United States
Ten20 Clinical ResearchRecruiting
Carrollton, Texas, United States
Horizon Clinical Research GroupRecruiting
Cypress, Texas, United States
Alina Clinical Trials, LLC.Recruiting
Dallas, Texas, United States
Greater Heights & Memorial Pulmonary and SleepRecruiting
Houston, Texas, United States
Houston Pulmonary Sleep and Allergy AssociatesRecruiting
Houston, Texas, United States
Sherman Clinical ResearchRecruiting
Sherman, Texas, United States
Synergy Respiratory CareRecruiting
Sherwood Park, Alberta, Canada
Dr. Syed Anees Medicine Professional CorporationRecruiting
Windsor, Ontario, Canada
C.I.C. Mauricie inc.Not Yet Recruiting
Trois-Rivières, Quebec, Canada
China-Japan Friendship HospitalNot Yet Recruiting
Beijing, Beijing Municipality, China
The Third Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Guangzhou, Guangdong, China
The First People's Hospital of XinxiangNot Yet Recruiting
Xinxiang, Henan, China
Zhongda Hospital Southeast UniversityRecruiting
Nanjing, Jiangsu, China
Ruijin Hospital Shanghai Jiaotong University School of MedicineRecruiting
Shanghai, Shanghai Municipality, China
Chengdu Fifth People's HospitalRecruiting
Chengdu, Sichuan, China
KLES Dr. Prabhakar Kore Hospital and Medical Research CentreRecruiting
Belagavi, Karnataka, India
Bhaktivedanta Hospital and Research InstituteRecruiting
Thane, Maharashtra, India
Sir Ganga Ram HospitalNot Yet Recruiting
New Delhi, National Capital Territory of Delhi, India
Jawahar Lal Nehru Medical CollegeNot Yet Recruiting
Ajmer, Rajasthan, India
Maharaja Agrasen Superspeciality HospitalRecruiting
Jaipur, Rajasthan, India
Hindusthan HospitalNot Yet Recruiting
Coimbatore, Tamil Nadu, India
Kamineni Hospitals Private LimitedNot Yet Recruiting
Hyderabad, Telangana, India
Shri Guru Ram Rai Institute of Medical & Health Sciences & Shri Mahant lndiresh HospitalNot Yet Recruiting
Dehradun, Uttarakhand, India
Koujunkai Daido ClinicNot Yet Recruiting
Nagoya, Aichi-ken, Japan
Nishifukuoka HospitalRecruiting
Fukuoka, Fukuoka, Japan
Aso Iizuka HospitalNot Yet Recruiting
Iizuka-shi, Fukuoka, Japan
Kure Kyosai HospitalRecruiting
Kure, Hiroshima, Japan
National Hospital Organization Okinawa HospitalRecruiting
Ginowan, Okinawa, Japan
NHO Kinki Chuo Chest Medical CenterNot Yet Recruiting
Sakai, Osaka, Japan
Fujieda Municipal General HospitalNot Yet Recruiting
Fujieda, Shizuoka, Japan
Tokyo Medical University Hachioji Medical CenterNot Yet Recruiting
Hachiōji, Tokyo, Japan
Yamaguchi University HospitalNot Yet Recruiting
Ube, Yamaguchi, Japan
Jeonbuk National University HospitalRecruiting
Jeonju, Jeonbuk-do, South Korea
Korea University Anam HospitalRecruiting
Seoul, Seoul-teukbyeolsi [seoul], South Korea
The Catholic University of Korea, Eunpyeong St. Mary's HospitalNot Yet Recruiting
Seoul, South Korea
The Catholic Univ. of Korea Seoul St. Mary's HospitalNot Yet Recruiting
Seoul, South Korea
National Taiwan University Hospital - Hsinchu branchNot Yet Recruiting
Hsinchu, Taiwan
Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Far Eastern Memorial HospitalNot Yet Recruiting
New Taipei City, Taiwan
China Medical University HospitalRecruiting
Taichung, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
National Taiwan University HospitalNot Yet Recruiting
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou BranchNot Yet Recruiting
Taoyuan, Taiwan
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease · TrialPath