- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07363694
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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:
- 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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Pfizer CT.gov Call Center
- Phone Number: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Locations
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Mendoza, Argentina, 5500
- Recruiting
- Instituto de Salud Respiratoria - (INSARES)
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1012AAR
- Recruiting
- IDIM - Instituto de Investigaciones Metabólicas
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
- Recruiting
- Centro Médico Dra. De Salvo - Fundación Respirar
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Alberta
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Sherwood Park, Alberta, Canada, T8H 0N2
- Recruiting
- Synergy Respiratory Care
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Ontario
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Windsor, Ontario, Canada, N8X 1T3
- Recruiting
- Dr. Syed Anees Medicine Professional Corporation
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Quebec
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Trois-Rivières, Quebec, Canada, G8T 7A1
- Not yet recruiting
- C.I.C. Mauricie inc.
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Anhui
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Chizhou, Anhui, China, 247000
- Not yet recruiting
- The People's Hospital of Chizhou
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Fuyang, Anhui, China, 236000
- Not yet recruiting
- Fuyang People's Hospital
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Hefei, Anhui, China, 230022
- Not yet recruiting
- Anhui Chest Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100029
- Not yet recruiting
- China-Japan Friendship Hospital
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Guangdong
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Guangzhou, Guangdong, China, 510150
- Recruiting
- The Third Affiliated Hospital of Guangzhou Medical University
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Huizhou, Guangdong, China, 516001
- Not yet recruiting
- Huizhou Central People's Hospital
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Henan
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Xinxiang, Henan, China, 453000
- Recruiting
- The First People's Hospital of Xinxiang
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Inner Mongolia
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Hohhot, Inner Mongolia, China, 010050
- Not yet recruiting
- The Affiliated Hospital of Inner Mongolia Medical University
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Hohhot, Inner Mongolia, China, 010017
- Recruiting
- Inner Mongolia People's Hospital
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Jiangsu
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Nanjing, Jiangsu, China, 210009
- Recruiting
- Zhongda Hospital Southeast University
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Xuzhou, Jiangsu, China, 221006
- Not yet recruiting
- The Affiliated Hospital of Xuzhou Medical College
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Yangzhou, Jiangsu, China, 225012
- Recruiting
- Yangzhou University-Affiliated Hospital
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Jiangxi
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Nanchang, Jiangxi, China, 330038
- Recruiting
- Jiangxi Provincial People's Hospital
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Shandong
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Jinan, Shandong, China, 250013
- Recruiting
- Jinan Central Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200025
- Recruiting
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
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Shanghai, Shanghai Municipality, China, 200065
- Not yet recruiting
- Shanghai Tongji Hospital
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Sichuan
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Chengdu, Sichuan, China, 611130
- Recruiting
- Chengdu Fifth People's Hospital
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Zhejiang
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Linhai, Zhejiang, China, 317000
- Recruiting
- Taizhou Hospital of Zhejiang Province
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Brandýs nad Labem-Stará Boleslav, Czechia, 250 01
- Not yet recruiting
- MUDr.I. Cierna Peterova s.r.o.
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Jindřichův Hradec, Czechia, 377 01
- Recruiting
- MediTrial s.r.o.
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Ústí nad Labem Region
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Varnsdorf, Ústí nad Labem Region, Czechia, 407 47
- Not yet recruiting
- Pneumologie Varnsdorf s.r.o.
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Pest County
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Gödöllő, Pest County, Hungary, 2100
- Not yet recruiting
- Erzsebet Gondozohaz
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Karnataka
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Belagavi, Karnataka, India, 590010
- Recruiting
- KLES Dr. Prabhakar Kore Hospital and Medical Research Centre
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Maharashtra
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Thane, Maharashtra, India, 401107
- Recruiting
- Bhaktivedanta Hospital and Research Institute
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, India, 110060
- Recruiting
- Sir Ganga Ram Hospital
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Rajasthan
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Ajmer, Rajasthan, India, 305001
- Not yet recruiting
- Jawahar Lal Nehru Medical College
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Jaipur, Rajasthan, India, 302039
- Recruiting
- Maharaja Agrasen Superspeciality Hospital
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Tamil Nadu
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Coimbatore, Tamil Nadu, India, 641028
- Recruiting
- Hindusthan Hospital
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Telangana
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Hyderabad, Telangana, India, 500068
- Recruiting
- Kamineni Hospitals Private Limited
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Uttarakhand
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Dehradun, Uttarakhand, India, 248001
- Recruiting
- Shri Guru Ram Rai Institute of Medical & Health Sciences & Shri Mahant lndiresh Hospital
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West Bengal
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Kolkata, West Bengal, India, 700014
- Recruiting
- Nil Ratan Sircar Medical College and Hospital
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Hiroshima, Japan, 734-8530
- Recruiting
- Hiroshima Prefectural Hospital
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 457-8511
- Recruiting
- Koujunkai Daido Clinic
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Fukuoka
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Fukuoka, Fukuoka, Japan, 819-8555
- Recruiting
- Nishifukuoka Hospital
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Iizuka-shi, Fukuoka, Japan, 820-8505
- Recruiting
- Aso Iizuka Hospital
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Hiroshima
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Kure, Hiroshima, Japan, 737-8505
- Recruiting
- Kure Kyosai Hospital
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Okinawa
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Ginowan, Okinawa, Japan, 901-2214
- Recruiting
- National Hospital Organization Okinawa Hospital
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Osaka
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Sakai, Osaka, Japan, 591-8555
- Recruiting
- NHO Kinki Chuo Chest Medical Center
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Shizuoka
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Fujieda, Shizuoka, Japan, 426-8677
- Recruiting
- Fujieda Municipal General Hospital
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Tokyo
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Hachiōji, Tokyo, Japan, 1930998
- Recruiting
- Tokyo Medical University Hachioji Medical Center
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Yamaguchi
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Ube, Yamaguchi, Japan, 755-8505
- Recruiting
- Yamaguchi University Hospital
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Seoul, South Korea, 05030
- Recruiting
- Konkuk University Medical Center
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Seoul, South Korea, 06591
- Recruiting
- The Catholic Univ. of Korea Seoul St. Mary's Hospital
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Seoul, South Korea, 03312
- Recruiting
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital
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Jeonbuk-do
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Jeonju, Jeonbuk-do, South Korea, 54907
- Recruiting
- Jeonbuk National University Hospital
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Seoul-teukbyeolsi [seoul]
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Seoul, Seoul-teukbyeolsi [seoul], South Korea, 02841
- Recruiting
- Korea University Anam Hospital
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Hsinchu, Taiwan, 302
- Recruiting
- National Taiwan University Hospital - Hsinchu branch
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Kaohsiung City, Taiwan, 807
- Recruiting
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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New Taipei City, Taiwan, 220
- Recruiting
- Far Eastern Memorial Hospital
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Taichung, Taiwan, 40447
- Recruiting
- China Medical University Hospital
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Taichung, Taiwan, 407219
- Recruiting
- Taichung Veterans General Hospital
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Taipei, Taiwan, 10002
- Recruiting
- National Taiwan University Hospital
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Taoyuan, Taiwan, 333
- Recruiting
- Chang Gung Medical Foundation-Linkou Branch
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Alabama
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Birmingham, Alabama, United States, 35233
- Recruiting
- University of Alabama at Birmingham Lung Health Center
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Dothan, Alabama, United States, 36305
- Recruiting
- SEC Clinical Research
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Mobile, Alabama, United States, 36608
- Recruiting
- Pulmonary Associates of Mobile, P.C.
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Arizona
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Chandler, Arizona, United States, 85224
- Not yet recruiting
- Chandler Clinical Trials
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Phoenix, Arizona, United States, 85027
- Recruiting
- Pulmonary Associates, PA
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California
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La Palma, California, United States, 90623
- Recruiting
- IMAX Clinical Trials
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Newport Beach, California, United States, 92663
- Recruiting
- NewportNativeMD, Inc.
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Northridge, California, United States, 91324
- Recruiting
- California Medical Research Associates
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San Diego, California, United States, 92120
- Recruiting
- Institute of HealthCare Assessment d/b/a Apex Clinical Research
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Florida
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Greenacres City, Florida, United States, 33467
- Recruiting
- Finlay Medical Research
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Kissimmee, Florida, United States, 34746
- Recruiting
- Clinical Research Specialists LLC
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Loxahatchee Groves, Florida, United States, 33470
- Recruiting
- Advanced Pulmonary Research Institute
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Miami, Florida, United States, 33176
- Recruiting
- Reed Medical Research
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Ocala, Florida, United States, 34470
- Recruiting
- Renstar Medical Research
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Ocala, Florida, United States, 34471
- Recruiting
- Renstar Medical Research
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Ocala, Florida, United States, 34471
- Recruiting
- HCA Florida Ocala Imaging Center
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Ocala, Florida, United States, 34471
- Recruiting
- Ocala Lung and Critical Care Associates
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St. Petersburg, Florida, United States, 33704
- Recruiting
- Coastal Medical Research Institute, LLC
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St. Petersburg, Florida, United States, 33704
- Recruiting
- Coastal Pulmonary and Critical Care, P.L.C
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Tampa, Florida, United States, 33607
- Recruiting
- Clinical Research Trials of Florida, Inc.
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Winter Park, Florida, United States, 32789
- Recruiting
- Clinical Site Partners, LLC dba Flourish Research
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Georgia
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East Point, Georgia, United States, 30344
- Recruiting
- Cpcc-Research Llc
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Rincon, Georgia, United States, 31326
- Recruiting
- Centricity Research Rincon Pulmonology
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Indiana
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Hammond, Indiana, United States, 46324
- Recruiting
- ASHA Clinical Research - Munster, LLC
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Merrillville, Indiana, United States, 46410
- Recruiting
- Methodist Hospital Southlake
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Kansas
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Kansas City, Kansas, United States, 66160
- Not yet recruiting
- University of Kansas Medical Center
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Louisiana
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Zachary, Louisiana, United States, 70791
- Recruiting
- Southern Clinical Research, LLC
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Maine
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Bangor, Maine, United States, 04401
- Not yet recruiting
- Paul A. Shapero, MD, PA
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Massachusetts
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Fall River, Massachusetts, United States, 02723
- Not yet recruiting
- Exordia Medical Research Inc.
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North Dartmouth, Massachusetts, United States, 02747
- Not yet recruiting
- Infinity Medical Research
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Michigan
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Dearborn, Michigan, United States, 48126
- Recruiting
- Revival Research Institute, LLC
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Flint, Michigan, United States, 48504
- Recruiting
- AA Medical Research Center
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Southfield, Michigan, United States, 48075
- Recruiting
- Revive Research Institute, Inc.
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Troy, Michigan, United States, 48085
- Recruiting
- Oakland Medical Research
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Missouri
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St Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
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St Louis, Missouri, United States, 63108
- Recruiting
- Washington University School of Medicine
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St Louis, Missouri, United States, 63110
- Recruiting
- Barnes-Jewish Hospital
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St Louis, Missouri, United States, 63110
- Recruiting
- Barnes-Jewish Hospital Investigational Drug Service
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St Louis, Missouri, United States, 63110
- Recruiting
- Washington University School-Cardiovascular Imaging and Clinical Research Core Laboratory
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Nevada
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Henderson, Nevada, United States, 89052
- Recruiting
- Henderson Clinical Trials
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New York
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Chappaqua, New York, United States, 10514
- Not yet recruiting
- Northwell Health Physician Partners at Chappaqua
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Flushing, New York, United States, 11355
- Not yet recruiting
- New York Presbyterian Queens
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Mount Kisco, New York, United States, 10549
- Not yet recruiting
- Northern Westchester Hospital
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North Carolina
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Winston-Salem, North Carolina, United States, 27103
- Recruiting
- Southeastern Research Center
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Winston-Salem, North Carolina, United States, 27103
- Recruiting
- Salem Chest Specialists
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Ohio
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Toledo, Ohio, United States, 43617
- Not yet recruiting
- Toledo Institute of Clinical Research Inc.
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Pennsylvania
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DuBois, Pennsylvania, United States, 15801
- Recruiting
- Clinical Research Associates of Central PA, LLC
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South Carolina
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Columbia, South Carolina, United States, 29201
- Recruiting
- Bogan Sleep Consultants, LLC
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Gaffney, South Carolina, United States, 29340
- Recruiting
- Velocity Clinical Research, Gaffney
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Rock Hill, South Carolina, United States, 29732
- Recruiting
- Clinical Research of Rock Hill
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Spartanburg, South Carolina, United States, 29303
- Recruiting
- Velocity Clinical Research, Spartanburg
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South Dakota
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Rapid City, South Dakota, United States, 57702
- Recruiting
- Health Concepts
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Tennessee
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Franklin, Tennessee, United States, 37067
- Recruiting
- Clinical Trials Center of Middle Tennessee, LLC
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Hendersonville, Tennessee, United States, 37075
- Recruiting
- Premier Research Center, LLC
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Texas
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Boerne, Texas, United States, 78006
- Recruiting
- South Texas Medical Research Institute, Inc., DBA TTS Research
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Carrollton, Texas, United States, 75010
- Recruiting
- Ten20 Clinical Research
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Cypress, Texas, United States, 77429
- Recruiting
- Horizon Clinical Research Group
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Dallas, Texas, United States, 75209
- Recruiting
- Alina Clinical Trials, LLC.
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Houston, Texas, United States, 77008
- Recruiting
- Greater Heights & Memorial Pulmonary and Sleep
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Houston, Texas, United States, 77065
- Recruiting
- Houston Pulmonary Sleep and Allergy Associates
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Sherman, Texas, United States, 75090
- Recruiting
- Sherman Clinical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Phase 2 Treatment Arm A
|
SC injection dose 1
|
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Experimental: Phase 2 Treatment Arm B
|
SC injection dose 2
|
|
Placebo Comparator: Phase 2 Treatment Arm C
|
SC injection matched
|
|
Experimental: Phase 3 Treatment Arm A
|
SC injection dose 3
|
|
Placebo Comparator: Phase 3 Treatment Arm B
|
SC injection matched
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline to Week 24
|
|
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.
|
Baseline to Week 52
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Phase 2: Annualized rate of moderate or severe ECOPD.
Time Frame: Baseline to Week 24
|
Baseline to Week 24
|
|
Phase 2: Change from baseline in pre-BD FEV1 up to Week 24.
Time Frame: Baseline to Week 24
|
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
|
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
|
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
|
Baseline to Week 24
|
|
Phase 2: Incidence and severity of TEAEs throughout Phase 2 part of the study.
Time Frame: Baseline to Week 24
|
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
|
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
|
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
|
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
|
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
|
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
|
Baseline to Week 52
|
|
Phase 3: Annualized rate of severe ECOPD.
Time Frame: Baseline to Week 52
|
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
|
Baseline to Week 24
|
|
Phase 3: Annualized rate of exacerbations requiring emergency department visit and/or hospitalization.
Time Frame: Baseline to Week 52
|
Baseline to Week 52
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C4531031
- 2024-518587-12-00 (Registry Identifier: CTIS (EU))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.