Moderate to Severe Chronic Obstructive Pulmonary DiseasePhase 2/3COPDNCT07363694
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease
A Phase 2/3 study testing PF-07275315 dose 1, PF-07275315-dose 2 and PF-07275315-dose 3 in people with Moderate to Severe Chronic Obstructive Pulmonary Disease, run by Pfizer at 189 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Moderate to Severe Chronic Obstructive Pulmonary Disease
- What is being tested?
- PF-07275315 dose 1, PF-07275315-dose 2 and PF-07275315-dose 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,156 participants
- Where
- 189 sitesin 18 countries
- Study dates
- 11 Feb 2026to 16 Jan 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
189 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
189 sites in 18 countries
United States66 sites, 66 recruiting
- Not yet recruiting
Paul A. Shapero, MD, PA
Bangor, Maine, 04401
- Recruiting
University of Alabama at Birmingham Lung Health Center
Birmingham, Alabama, 35233
- Recruiting
South Texas Medical Research Institute, Inc., DBA TTS Research
Boerne, Texas, 78006
- Recruiting
Ten20 Clinical Research
Carrollton, Texas, 75010
- Not yet recruiting
Northwell Health Physician Partners at Chappaqua
Chappaqua, New York, 10514
- Recruiting
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201
- Recruiting
Horizon Clinical Research Group
Cypress, Texas, 77429
- Recruiting
Alina Clinical Trials, LLC.
Dallas, Texas, 75209
- Recruiting
Baylor Scott & White Advanced Lung Disease Specialists
Dallas, Texas, 75246
- Recruiting
Baylor University Medical Center (Research Office)
Dallas, Texas, 75246
- Recruiting
Baylor University Medical Center
Dallas, Texas, 75246
- Recruiting
Revival Research Institute, LLC
Dearborn, Michigan, 48126
- Recruiting
SEC Clinical Research
Dothan, Alabama, 36305
- Recruiting
Clinical Research Associates of Central PA, LLC
DuBois, Pennsylvania, 15801
- Recruiting
Cpcc-Research Llc
East Point, Georgia, 30344
- Recruiting
Exordia Medical Research Inc.
Fall River, Massachusetts, 02723
- Recruiting
AA Medical Research Center
Flint, Michigan, 48504
- Recruiting
New York Presbyterian Queens
Flushing, New York, 11355
- Recruiting
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee, 37067
- Recruiting
Velocity Clinical Research, Gaffney
Gaffney, South Carolina, 29340
- Recruiting
Finlay Medical Research
Greenacres City, Florida, 33467
- Recruiting
ASHA Clinical Research - Munster, LLC
Hammond, Indiana, 46324
- Recruiting
Henderson Clinical Trials
Henderson, Nevada, 89052
- Recruiting
Premier Research Center, LLC
Hendersonville, Tennessee, 37075
- Recruiting
Greater Heights & Memorial Pulmonary and Sleep
Houston, Texas, 77008
- Recruiting
Houston Pulmonary Sleep and Allergy Associates
Houston, Texas, 77065
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
- Recruiting
Clinical Research Specialists LLC
Kissimmee, Florida, 34746
- Recruiting
IMAX Clinical Trials
La Palma, California, 90623
- Recruiting
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, 33470
- Recruiting
Methodist Hospital Southlake
Merrillville, Indiana, 46410
- Recruiting
Reed Medical Research
Miami, Florida, 33176
- Recruiting
Pulmonary Associates of Mobile, P.C.
Mobile, Alabama, 36608
- Not yet recruiting
Northern Westchester Hospital
Mount Kisco, New York, 10549
- Recruiting
NewportNativeMD, Inc.
Newport Beach, California, 92663
- Recruiting
Infinity Medical Research
North Dartmouth, Massachusetts, 02747
- Recruiting
California Medical Research Associates
Northridge, California, 91324
- Recruiting
Renstar Medical Research
Ocala, Florida, 34470
- Recruiting
HCA Florida Ocala Imaging Center
Ocala, Florida, 34471
- Recruiting
Ocala Lung and Critical Care Associates
Ocala, Florida, 34471
- Recruiting
Renstar Medical Research
Ocala, Florida, 34471
- Not yet recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
- Recruiting
Pulmonary Associates, PA
Phoenix, Arizona, 85027
- Not yet recruiting
Temple Health Oaks
Phoenixville, Pennsylvania, 19460
- Recruiting
Health Concepts
Rapid City, South Dakota, 57702
- Recruiting
Centricity Research Rincon Pulmonology
Rincon, Georgia, 31326
- Recruiting
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
- Recruiting
Institute of HealthCare Assessment d/b/a Apex Clinical Research
San Diego, California, 92120
- Recruiting
Sherman Clinical Research
Sherman, Texas, 75090
- Recruiting
Revive Research Institute, Inc.
Southfield, Michigan, 48075
- Recruiting
Velocity Clinical Research, Spartanburg
Spartanburg, South Carolina, 29303
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63108
- Recruiting
Barnes-Jewish Hospital Investigational Drug Service
St Louis, Missouri, 63110
- Recruiting
Barnes-Jewish Hospital
St Louis, Missouri, 63110
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
- Recruiting
Washington University School-Cardiovascular Imaging and Clinical Research Core Laboratory
St Louis, Missouri, 63110
- Recruiting
Coastal Medical Research Institute, LLC
St. Petersburg, Florida, 33704
- Recruiting
Coastal Pulmonary and Critical Care, P.L.C
St. Petersburg, Florida, 33704
- Recruiting
Clinical Research Trials of Florida, Inc.
Tampa, Florida, 33607
- Recruiting
Toledo Institute of Clinical Research Inc.
Toledo, Ohio, 43617
- Recruiting
Oakland Medical Research
Troy, Michigan, 48085
- Recruiting
Layrek Clinical Research
Tulsa, Oklahoma, 74133
- Recruiting
Salem Chest Specialists
Winston-Salem, North Carolina, 27103
- Recruiting
Southeastern Research Center
Winston-Salem, North Carolina, 27103
- Recruiting
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, 32789
- Recruiting
Southern Clinical Research, LLC
Zachary, Louisiana, 70791
China22 sites, 22 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
- Recruiting
The First Hospital of Changsha
Changsha, Hunan, 410005
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
- Recruiting
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 611130
- Recruiting
The People's Hospital of Chizhou
Chizhou, Anhui, 247000
- Recruiting
Chongqing Red Cross Hospital (Jiangbei District People's Hospital)
Chongqing, Chongqing Municipality, 400000
- Recruiting
Fuyang People's Hospital
Fuyang, Anhui, 236000
- Recruiting
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510150
- Recruiting
Anhui Chest Hospital
Hefei, Anhui, 230022
- Recruiting
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, 010017
- Recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010050
- Recruiting
Huizhou Central People's Hospital
Huizhou, Guangdong, 516001
- Recruiting
Jinan Central Hospital
Jinan, Shandong, 250013
- Recruiting
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, 317000
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330038
- Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
- Recruiting
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
- Recruiting
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200065
- Recruiting
The Central Hospital of Wuhan
Wuhan, Hubei, 430024
- Recruiting
The First People's Hospital of Xinxiang
Xinxiang, Henan, 453000
- Recruiting
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, 221006
- Recruiting
Yangzhou University-Affiliated Hospital
Yangzhou, Jiangsu, 225012
Bulgaria10 sites, 10 recruiting
- Recruiting
MHAT "Sveta Ekaterina" Dimitrovgrad
Dimitrovgrad, 6400
- Recruiting
Medical Center Pulmo - 2018 EOOD
Haskovo, Haskovo, 6300
- Recruiting
Specialized Hospital for Active Treatment of Lung Diseases - Sv. Panteleymon EOOD
Pernik, Pernik, 2300
- Recruiting
Medical Center Fama Medical
Plovdiv
- Recruiting
SHATPPD Dr. Dimitar Gramatikov - Ruse EOOD
Rousse, Ruse, 7002
- Recruiting
MHAT Knyaginya Klementina - Sofia EAD
Sofia, Sofia, 1233
- Recruiting
Medical Center Hera EOOD
Sofia, Sofia (stolitsa), 1510
- Recruiting
Fifth MHAT EAD
Sofia, 1233
- Recruiting
Medical Center New Rehabilitation Center EOOD
Stara Zagora, Stara Zagora, 6001
- Recruiting
Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Dr. Treiman
Veliko Tarnovo, Veliko Tarnovo, 5000
Japan10 sites, 10 recruiting
- Recruiting
Fujieda Municipal General Hospital
Fujieda, Shizuoka, 426-8677
- Recruiting
Nishifukuoka Hospital
Fukuoka, Fukuoka, 819-8555
- Recruiting
National Hospital Organization Okinawa Hospital
Ginowan, Okinawa, 901-2214
- Recruiting
Tokyo Medical University Hachioji Medical Center
Hachiōji, Tokyo, 1930998
- Recruiting
Hiroshima Prefectural Hospital
Hiroshima, Hiroshima, 734-8530
- Recruiting
Aso Iizuka Hospital
Iizuka-shi, Fukuoka, 820-8505
- Recruiting
Kure Kyosai Hospital
Kure, Hiroshima, 737-8505
- Recruiting
Koujunkai Daido Clinic
Nagoya, Aichi-ken, 457-8511
- Recruiting
NHO Kinki Chuo Chest Medical Center
Sakai, Osaka, 591-8555
- Recruiting
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505
India9 sites, 9 recruiting
- Recruiting
KLES Dr. Prabhakar Kore Hospital and Medical Research Centre
Belagavi, Karnataka, 590010
- Recruiting
Hindusthan Hospital
Coimbatore, Tamil Nadu, 641028
- Recruiting
Shri Guru Ram Rai Institute of Medical & Health Sciences & Shri Mahant lndiresh Hospital
Dehradun, Uttarakhand, 248001
- Recruiting
Kamineni Hospitals Private Limited
Hyderabad, Telangana, 500068
- Recruiting
Maharaja Agrasen Superspeciality Hospital
Jaipur, Rajasthan, 302039
- Recruiting
Nil Ratan Sircar Medical College and Hospital
Kolkata, West Bengal, 700014
- Recruiting
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
- Recruiting
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
- Recruiting
Bhaktivedanta Hospital and Research Institute
Thane, Maharashtra, 401107
United Kingdom8 sites, 8 recruiting
- Recruiting
Bradford Royal Infirmary
Bradford, BRADFORD, BD9 6RJ
- Recruiting
Ashford and St Peter's Hospital NHS Foundation Trust
Chertsey, KT16 0PZ
- Recruiting
Glasgow Royal Infirmary
Glasgow, CITY of Glasgow, G31 2ER
- Recruiting
The Glenfield Hospital
Leicester, LEICESTERSHIRE, LE3 9QP
- Not yet recruiting
Guy's & St Thomas' NHS Foundation Trust
London, London, CITY of, SE1 9RT
- Recruiting
Queen Anne Street Medical Centre
London, W1T 6AH
- Recruiting
Wythenshawe Hospital
Manchester, MANCHESTER, M23 9LT
- Not yet recruiting
North Tyneside General Hospital
North Shields, NE29 8NH
Poland7 sites, 7 recruiting
- Recruiting
Centrum Medyczne Pratia Katowice
Katowice, 40-081
- Recruiting
Pro Familia Altera Sp. z o.o.
Katowice, 40-648
- Recruiting
Diamond Clinic Sp. z o.o.
Krakow, 31-559
- Recruiting
Ostrowieckie Centrum Medyczne spółka cywilna Anna Olech-Cudzik, Krzysztof Cudzik
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400
- Not yet recruiting
Centermed Sp. z o.o.
Tarnów, 33-100
- Recruiting
ETG Warszawa
Warsaw, 02-677
- Recruiting
DOBROSTAN - Gabinety Lekarskie
Wroclaw, 53-301
Taiwan7 sites, 7 recruiting
- Recruiting
National Taiwan University Hospital - Hsinchu branch
Hsinchu, 302
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Kaohsiung, 807
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, 220
- Recruiting
Taichung Veterans General Hospital
Taichung, TAICHUNG, 407219
- Recruiting
China Medical University Hospital
Taichung, 40447
- Recruiting
National Taiwan University Hospital
Taipei, 10002
- Recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, TAOYUAN, 333
Argentina6 sites, 6 recruiting
- Recruiting
IDIM - Instituto de Investigaciones Metabólicas
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1012AAR
- Recruiting
Centro Médico Dra. De Salvo - Fundación Respirar
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ABP
- Recruiting
Instituto Médico DAMIC
Córdoba, Córdoba Province, X5003DCE
- Recruiting
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, Buenos Aires, 7600
- Recruiting
Instituto de Salud Respiratoria - (INSARES)
Mendoza, Mendoza Province, 5500
- Recruiting
Fundación Grupo Colaborativo Rosario Investigación y Prevención Médica
Rosario, Santa Fe Province, 2000
Czechia6 sites, 6 recruiting
- Recruiting
MUDr.I. Cierna Peterova s.r.o.
Brandýs nad Labem-Stará Boleslav, 250 01
- Recruiting
MEDITRIAL s.r.o.
Jindřichův Hradec, 377 01
- Recruiting
Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje
Mladá Boleslav, 293 01
- Recruiting
Ordinace chorob plicnich s.r.o.
Prague, 11000
- Recruiting
MEDICON a.s.
Prague, 140 00
- Not yet recruiting
Pneumologie Varnsdorf s.r.o.
Varnsdorf, Ústí nad Labem Region, 407 47
Germany6 sites, 6 recruiting
- Recruiting
KPPK Studienzentrum GmbH
Bendorf, Rhineland-Palatinate, 56170
- Not yet recruiting
Clinical Studies Pankow
Berlin, 13187
- Not yet recruiting
Klifeck GmbH
Delitzsch, 04509
- Not yet recruiting
Medizentrum Essen Borbeck
Essen, North Rhine-Westphalia, 45355
- Recruiting
IKF Pneumologie GmbH & Co KG; Institut für klinische Forschung
Frankfurt, 60596
- Not yet recruiting
Pneumologisch Onkologisch Internistisches Studienzentrum (POIS) Sachsen GmbH
Leipzig, 04347
Hungary5 sites, 5 recruiting
- Not yet recruiting
Koch Róbert Kórház és Rendelőintézet
Edelény, Borsod-Abauj Zemplen county, 3780
- Recruiting
Erzsebet Gondozohaz
Gödöllő, Pest County, 2100
- Recruiting
Szalay János Rendelőintézet
Hajdúnánás, Hajdú-Bihar, 4080
- Not yet recruiting
Omnimodus Elixír Kft.
Mosonmagyaróvár, Győr-Moson-Sopron, 9200
- Not yet recruiting
Da Vinci Magánklinika
Pécs, 7635
Italy5 sites, 5 recruiting
- Not yet recruiting
Azienda Socio-Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, BERGAMO, 24127
- Not yet recruiting
Azienda Ospedaliero Universitaria di Ferrara -Arcispedale Sant' Anna
Cona, FERRARA, 44124
- Recruiting
San Paolo Hospital, ASST Santi Paolo e Carlo
Milan, Milan, 20142
- Recruiting
Azienda Arcispedale Santa Maria Nuova _Usl Di Reggio Emilia/Irccs
Reggio Emilia, Emilia-Romagna, 42123
- Not yet recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Roma, ROME, 00161
South Korea5 sites, 5 recruiting
- Recruiting
Jeonbuk National University Hospital
Jeonju, Jeonbuk-do, 54907
- Recruiting
Korea University Anam Hospital
Seoul, Seoul-teukbyeolsi [seoul], 02841
- Recruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312
- Recruiting
Konkuk University Medical Center
Seoul, 05030
- Recruiting
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, 06591
Spain5 sites, 5 recruiting
- Recruiting
Hospital Universitario Virgen de las Nieves (HUVN) - Hospital Materno Infantil
Granada, Andalusia, 18014
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, MÁLAGA, 29010
- Recruiting
Hospital de Merida
Mérida, BADAJOZ, 06800
- Not yet recruiting
Hospital Universitario Miguel Servet
Zaragoza, Aragon, 50009
- Not yet recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
Australia4 sites, 4 recruiting
- Not yet recruiting
Monash Health
Clayton, Victoria, 3168
- Not yet recruiting
Mater Misericordiae Limited
South Brisbane, Queensland, 4101
- Recruiting
TrialsWest - Spearwood
Spearwood, Western Australia, 6163
- Not yet recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Canada4 sites, 4 recruiting
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval (IUCPQ-UL)
Québec, Quebec, G1V 4G5
- Recruiting
Synergy Respiratory Care
Sherwood Park, Alberta, T8H 0N2
- Not yet recruiting
C.I.C. Mauricie inc.
Trois-Rivières, Quebec, G8T 7A1
- Recruiting
Dr. Syed Anees Medicine Professional Corporation
Windsor, Ontario, N8X 1T3
France4 sites, 4 recruiting
- Not yet recruiting
Centre Hospitalier Annecy Genevois
Epagny Metz-Tessy, 74370
- Not yet recruiting
Hôpital de la Croix Rousse
Lyon, 69004
- Not yet recruiting
Hôpital Arnaud de Villeneuve - CHU Montpellier
Montpellier, HÉRAULT, 34090
- Not yet recruiting
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, PARIS, 75679
About this study
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)
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:
Read more
- 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.
- Being tested
- PF-07275315 dose 1, PF-07275315-dose 2, Placebo, PF-07275315-dose 3
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07275315 dose 1Drug
SC injection dose 1
PF-07275315-dose 2Drug
SC injection dose 2
PlaceboDrug
SC injection matched
PF-07275315-dose 3Drug
SC injection dose 3
| Study group | Role | What they receive |
|---|---|---|
| Phase 3 Treatment Arm A | Experimental | Not described Receives: Drug: PF-07275315-dose 3 |
| Phase 2 Treatment Arm B | Experimental | Not described Receives: Drug: PF-07275315-dose 2 |
| Phase 2 Treatment Arm A | Experimental | Not described Receives: Drug: PF-07275315 dose 1 |
| Phase 3 Treatment Arm B | Placebo comparator | Not described Receives: Drug: Placebo |
| Phase 2 Treatment Arm C | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 2 part: Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at 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.
Measured: Baseline to Week 24
Phase 3 part: Annualized rate of moderate or severe ECOPD
Exacerbation of Chronic Obstructive Pulmonary Disease (ECOPD) are sudden worsening of respiratory symptoms that significantly worsen lung function and quality of life.
Measured: Baseline to Week 52
Secondary outcomes (15)
Phase 2: Annualized rate of moderate or severe ECOPD.
Measured: Baseline to Week 24
Phase 2: Change from baseline in pre-BD FEV1 up to Week 24.
Measured: Baseline to Week 24
Phase 2: Change from baseline in trough, pre- and post-BD FEV1 up to Week 24
Measured: Baseline to Week 24
Phase 2: Change from baseline in trough, pre- and post-BD FVC and FEV1/FVC ratio, % predicted FEV1, % predicted FVC up to Week 24.
Measured: Baseline to Week 24
Phase 2: Change from baseline in trough FEV1 responsiveness to BD up to Week 24.
Measured: Baseline to Week 24
Phase 2: Incidence and severity of TEAEs throughout Phase 2 part of the study.
Measured: Baseline to Week 24
Phase 2: Incidence of treatment-emergent adverse events and serious adverse events leading to discontinuation.
Measured: Baseline to Week 24
Phase 2: Incidence of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs.
Measured: Baseline to Week 24
Phase 3: change from baseline in pre- and post-BD FEV1 at Week 12 and Week 52.
Measured: Baseline to Week 52
Phase 3: Percentage of participants with ≥4 points improvement from baseline in Saint George's Respiratory Questionnaire (SGRQ) score at Week 52.
Measured: Baseline to Week 52
Phase 3: Percentage of participants with ≥2 points improvement from baseline in the COPD Assessment Test (CAT) total score at Week 52.
Measured: Baseline to Week 52
Phase 3: Percentage of participants with ≥2 points improvement from baseline in E-RS:COPD total score at Week 52.
Measured: Baseline to Week 52
Phase 3: Annualized rate of severe ECOPD.
Measured: Baseline to Week 52
Phase 2: Change from baseline of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs.
Measured: Baseline to Week 24
Phase 3: Annualized rate of exacerbations requiring emergency department visit and/or hospitalization.
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start11 Feb 2026
- Primary completion24 Oct 2030 (estimated)
- Study completion16 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363694
- Sponsor's protocol ID
- C4531031
- Other IDs
- 2024-518587-12-00
- Acronym
- COPD
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07363694
- Acronym / sponsor ID
- COPD / C4531031
- Keywords
- COPD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,156 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 24 Oct 2030 (estimated)
- Study completion
- 16 Jan 2031 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 3 Treatment Arm A | Experimental | Drug: PF-07275315-dose 3 |
| Phase 2 Treatment Arm B | Experimental | Drug: PF-07275315-dose 2 |
| Phase 2 Treatment Arm A | Experimental | Drug: PF-07275315 dose 1 |
| Phase 3 Treatment Arm B | Placebo comparator | Drug: Placebo |
| Phase 2 Treatment Arm C | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-07275315 dose 1SC injection dose 1 | Drug | Phase 2 Treatment Arm A |
| PF-07275315-dose 2SC injection dose 2 | Drug | Phase 2 Treatment Arm B |
| PlaceboSC injection matched | Drug | Phase 2 Treatment Arm C, Phase 3 Treatment Arm B |
| PF-07275315-dose 3SC injection dose 3 | Drug | Phase 3 Treatment Arm A |
Primary outcome
Phase 2 part: Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24
Time frame: 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
Time frame: 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.
15 secondary outcomes
Phase 2: Annualized rate of moderate or severe ECOPD.
Time frame: Baseline to Week 24
Phase 2: Change from baseline in pre-BD FEV1 up to Week 24.
Time frame: Baseline to Week 24
Phase 2: Change from baseline in trough, pre- and post-BD FEV1 up to Week 24
Time frame: Baseline to Week 24
Phase 2: Change from baseline in trough, pre- and post-BD FVC and FEV1/FVC ratio, % predicted FEV1, % predicted FVC up to Week 24.
Time frame: Baseline to Week 24
Phase 2: Change from baseline in trough FEV1 responsiveness to BD up to Week 24.
Time frame: Baseline to Week 24
Phase 2: Incidence and severity of TEAEs throughout Phase 2 part of the study.
Time frame: Baseline to Week 24
Phase 2: Incidence of treatment-emergent adverse events and serious adverse events leading to discontinuation.
Time frame: Baseline to Week 24
Phase 2: Incidence of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs.
Time frame: Baseline to Week 24
Phase 3: change from baseline in pre- and post-BD FEV1 at Week 12 and Week 52.
Time frame: Baseline to Week 52
Phase 3: Percentage of participants with ≥4 points improvement from baseline in Saint George's Respiratory Questionnaire (SGRQ) score at Week 52.
Time frame: Baseline to Week 52
Phase 3: Percentage of participants with ≥2 points improvement from baseline in the COPD Assessment Test (CAT) total score at Week 52.
Time frame: Baseline to Week 52
Phase 3: Percentage of participants with ≥2 points improvement from baseline in E-RS:COPD total score at Week 52.
Time frame: Baseline to Week 52
Phase 3: Annualized rate of severe ECOPD.
Time frame: Baseline to Week 52
Phase 2: Change from baseline of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs.
Time frame: Baseline to Week 24
Phase 3: Annualized rate of exacerbations requiring emergency department visit and/or hospitalization.
Time frame: Baseline to Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
189 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PF-07275315 dose 1, PF-07275315-dose 2 and PF-07275315-dose 3 in people with Moderate to Severe Chronic Obstructive Pulmonary Disease, run by Pfizer at 189 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 189 sites in United States, China, Bulgaria, Japan, India and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 2 part: Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (time frame: Baseline to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.