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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518587-12-00 | Registry Identifier | CTIS (EU) |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2 Treatment Arm A | Experimental |
| |
| Phase 2 Treatment Arm B | Experimental |
| |
| Phase 2 Treatment Arm C | Placebo Comparator |
| |
| Phase 3 Treatment Arm A | Experimental |
| |
| Phase 3 Treatment Arm B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07275315 dose 1 | Drug | SC injection dose 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Annualized rate of moderate or severe ECOPD. | Baseline to Week 24 | |
| Phase 2: Change from baseline in pre-BD FEV1 up to Week 24. | Baseline to Week 24 | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Lung Health Center | Recruiting | Birmingham | Alabama | 35233 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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All dosing syringes will be masked and an unblinded administrator will administer the study intervention.
| PF-07275315-dose 2 |
| Drug |
SC injection dose 2 |
|
| Placebo | Drug | SC injection matched |
|
| PF-07275315-dose 3 | Drug | SC injection dose 3 |
|
| Phase 2: Change from baseline in trough, pre- and post-BD FEV1 up 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. | Baseline to Week 24 |
| Phase 2: Change from baseline in trough FEV1 responsiveness to BD up to Week 24. | Baseline to Week 24 |
| Phase 2: Incidence and severity of TEAEs throughout Phase 2 part of the study. | Baseline to Week 24 |
| Phase 2: Incidence of treatment-emergent adverse events and serious adverse events leading to discontinuation. | Baseline to Week 24 |
| Phase 2: Incidence of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs. | Baseline to Week 24 |
| Phase 3: change from baseline in pre- and post-BD FEV1 at Week 12 and Week 52. | Baseline to Week 52 |
| Phase 3: Percentage of participants with â„4 points improvement from baseline in Saint George's Respiratory Questionnaire (SGRQ) score at Week 52. | Baseline to Week 52 |
| Phase 3: Percentage of participants with â„2 points improvement from baseline in the COPD Assessment Test (CAT) total score at Week 52. | Baseline to Week 52 |
| Phase 3: Percentage of participants with â„2 points improvement from baseline in E-RS:COPD total score at Week 52. | Baseline to Week 52 |
| Phase 3: Annualized rate of severe ECOPD. | Baseline to Week 52 |
| Phase 2: Change from baseline of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs. | Baseline to Week 24 |
| Phase 3: Annualized rate of exacerbations requiring emergency department visit and/or hospitalization. | Baseline to Week 52 |
| SEC Clinical Research |
| Recruiting |
| Dothan |
| Alabama |
| 36305 |
| United States |
| Pulmonary Associates of Mobile, P.C. | Recruiting | Mobile | Alabama | 36608 | United States |
| Chandler Clinical Trials | Not yet recruiting | Chandler | Arizona | 85224 | United States |
| Pulmonary Associates, PA | Recruiting | Phoenix | Arizona | 85027 | United States |
| IMAX Clinical Trials | Recruiting | La Palma | California | 90623 | United States |
| NewportNativeMD, Inc. | Recruiting | Newport Beach | California | 92663 | United States |
| California Medical Research Associates | Recruiting | Northridge | California | 91324 | United States |
| Institute of HealthCare Assessment d/b/a Apex Clinical Research | Recruiting | San Diego | California | 92120 | United States |
| Finlay Medical Research | Recruiting | Greenacres City | Florida | 33467 | United States |
| Clinical Research Specialists LLC | Not yet recruiting | Kissimmee | Florida | 34746 | United States |
| Advanced Pulmonary Research Institute | Recruiting | Loxahatchee Groves | Florida | 33470 | United States |
| Reed Medical Research | Recruiting | Miami | Florida | 33176 | United States |
| Renstar Medical Research | Recruiting | Ocala | Florida | 34470 | United States |
| HCA Florida Ocala Imaging Center | Recruiting | Ocala | Florida | 34471 | United States |
| Ocala Lung and Critical Care Associates | Recruiting | Ocala | Florida | 34471 | United States |
| Coastal Medical Research Institute, LLC | Recruiting | St. Petersburg | Florida | 33704 | United States |
| Coastal Pulmonary and Critical Care, P.L.C | Recruiting | St. Petersburg | Florida | 33704 | United States |
| Clinical Site Partners, LLC dba Flourish Research | Recruiting | Winter Park | Florida | 32789 | United States |
| Cpcc-Research Llc | Recruiting | East Point | Georgia | 30344 | United States |
| Centricity Research Rincon Pulmonology | Recruiting | Rincon | Georgia | 31326 | United States |
| ASHA Clinical Research - Munster, LLC | Recruiting | Hammond | Indiana | 46324 | United States |
| Methodist Hospital Southlake | Recruiting | Merrillville | Indiana | 46410 | United States |
| Southern Clinical Research, LLC | Not yet recruiting | Zachary | Louisiana | 70791 | United States |
| Paul A. Shapero, MD, PA | Not yet recruiting | Bangor | Maine | 04401 | United States |
| Revival Research Institute, LLC | Recruiting | Dearborn | Michigan | 48126 | United States |
| AA Medical Research Center | Recruiting | Flint | Michigan | 48504 | United States |
| Revive Research Institute, Inc. | Recruiting | Southfield | Michigan | 48075 | United States |
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63108 | United States |
| Barnes-Jewish Hospital Investigational Drug Service | Recruiting | St Louis | Missouri | 63110 | United States |
| Barnes-Jewish Hospital | Recruiting | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| Washington University School-Cardiovascular Imaging and Clinical Research Core Laboratory | Recruiting | St Louis | Missouri | 63110 | United States |
| Henderson Clinical Trials | Recruiting | Henderson | Nevada | 89052 | United States |
| Salem Chest Specialists | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
| Southeastern Research Center | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
| Toledo Institute of Clinical Research Inc. | Not yet recruiting | Toledo | Ohio | 43617 | United States |
| Clinical Research Associates of Central PA, LLC | Recruiting | DuBois | Pennsylvania | 15801 | United States |
| Velocity Clinical Research, Gaffney | Recruiting | Gaffney | South Carolina | 29340 | United States |
| Clinical Research of Rock Hill | Recruiting | Rock Hill | South Carolina | 29732 | United States |
| Velocity Clinical Research, Spartanburg | Recruiting | Spartanburg | South Carolina | 29303 | United States |
| Health Concepts | Recruiting | Rapid City | South Dakota | 57702 | United States |
| Clinical Trials Center of Middle Tennessee, LLC | Recruiting | Franklin | Tennessee | 37067 | United States |
| Premier Research Center, LLC | Recruiting | Hendersonville | Tennessee | 37075 | United States |
| Ten20 Clinical Research | Recruiting | Carrollton | Texas | 75010 | United States |
| Horizon Clinical Research Group | Recruiting | Cypress | Texas | 77429 | United States |
| Alina Clinical Trials, LLC. | Recruiting | Dallas | Texas | 75209 | United States |
| Greater Heights & Memorial Pulmonary and Sleep | Recruiting | Houston | Texas | 77008 | United States |
| Houston Pulmonary Sleep and Allergy Associates | Recruiting | Houston | Texas | 77065 | United States |
| Sherman Clinical Research | Recruiting | Sherman | Texas | 75090 | United States |
| Synergy Respiratory Care | Recruiting | Sherwood Park | Alberta | T8H 0N2 | Canada |
| Dr. Syed Anees Medicine Professional Corporation | Recruiting | Windsor | Ontario | N8X 1T3 | Canada |
| C.I.C. Mauricie inc. | Not yet recruiting | Trois-RiviĂšres | Quebec | G8T 7A1 | Canada |
| China-Japan Friendship Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100029 | China |
| The Third Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510150 | China |
| The First People's Hospital of Xinxiang | Not yet recruiting | Xinxiang | Henan | 453000 | China |
| Zhongda Hospital Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
| Chengdu Fifth People's Hospital | Recruiting | Chengdu | Sichuan | 611130 | China |
| KLES Dr. Prabhakar Kore Hospital and Medical Research Centre | Recruiting | Belagavi | Karnataka | 590010 | India |
| Bhaktivedanta Hospital and Research Institute | Recruiting | Thane | Maharashtra | 401107 | India |
| Sir Ganga Ram Hospital | Not yet recruiting | New Delhi | National Capital Territory of Delhi | 110060 | India |
| Jawahar Lal Nehru Medical College | Not yet recruiting | Ajmer | Rajasthan | 305001 | India |
| Maharaja Agrasen Superspeciality Hospital | Recruiting | Jaipur | Rajasthan | 302039 | India |
| Hindusthan Hospital | Not yet recruiting | Coimbatore | Tamil Nadu | 641028 | India |
| Kamineni Hospitals Private Limited | Not yet recruiting | Hyderabad | Telangana | 500068 | India |
| Shri Guru Ram Rai Institute of Medical & Health Sciences & Shri Mahant lndiresh Hospital | Not yet recruiting | Dehradun | Uttarakhand | 248001 | India |
| Koujunkai Daido Clinic | Not yet recruiting | Nagoya | Aichi-ken | 457-8511 | Japan |
| Nishifukuoka Hospital | Recruiting | Fukuoka | Fukuoka | 819-8555 | Japan |
| Aso Iizuka Hospital | Not yet recruiting | Iizuka-shi | Fukuoka | 820-8505 | Japan |
| Kure Kyosai Hospital | Recruiting | Kure | Hiroshima | 737-8505 | Japan |
| National Hospital Organization Okinawa Hospital | Recruiting | Ginowan | Okinawa | 901-2214 | Japan |
| NHO Kinki Chuo Chest Medical Center | Not yet recruiting | Sakai | Osaka | 591-8555 | Japan |
| Fujieda Municipal General Hospital | Not yet recruiting | Fujieda | Shizuoka | 426-0077 | Japan |
| Tokyo Medical University Hachioji Medical Center | Not yet recruiting | HachiĆji | Tokyo | 1930998 | Japan |
| Yamaguchi University Hospital | Not yet recruiting | Ube | Yamaguchi | 755-8505 | Japan |
| Jeonbuk National University Hospital | Recruiting | Jeonju | Jeonbuk-do | 54907 | South Korea |
| Korea University Anam Hospital | Recruiting | Seoul | Seoul-teukbyeolsi [seoul] | 02841 | South Korea |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital | Not yet recruiting | Seoul | 03312 | South Korea |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital | Not yet recruiting | Seoul | 06591 | South Korea |
| National Taiwan University Hospital - Hsinchu branch | Not yet recruiting | Hsinchu | 302 | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting | Kaohsiung City | 807 | Taiwan |
| Far Eastern Memorial Hospital | Not yet recruiting | New Taipei City | 220 | Taiwan |
| China Medical University Hospital | Recruiting | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Recruiting | Taichung | 407219 | Taiwan |
| National Taiwan University Hospital | Not yet recruiting | Taipei | 10002 | Taiwan |
| Chang Gung Medical Foundation-Linkou Branch | Not yet recruiting | Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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