A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified January 2026 by Pfizer
Sponsor
Pfizer
Information Provided by (Responsible Party)
Pfizer
Clinicaltrials.gov Identifier
NCT06977581
Other Study ID Numbers:
C4531029
First Submitted
April 24, 2025
First Posted
May 17, 2025
Last Update Posted
February 17, 2026
Last Verified
January 2026

ClinicalTrials.gov processed this data on February 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Asthma
Drug: PF-07275315Drug: PF-07275315Drug: PF-07275315Other: Placebo

Study Design

Study TypeInterventional
Actual Enrollment252 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Dose-Ranging Study to Investigate the Efficacy and Safety of PF-07275315 in Adult Participants With Inadequately Controlled Moderate-to-Severe Asthma
Study Start DateMay 19, 2025
Actual Primary Completion Date10mos 1w from now
Actual Study Completion Date1yr 1mo from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Treatment Arm A
PF-07275315
Drug: PF-07275315
subcutaneous injection
Treatment Arm B
PF-07275315
Drug: PF-07275315
subcutaneous injection
Treatment Arm C
PF-07275315
Drug: PF-07275315
subcutaneous injection
Treatment Arm D
Placebo
Other: Placebo
subcutaneous injection

Outcome Measures

Primary Outcome Measures
  1. Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12
    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.
  2. Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs/SAEs leading to treatment discontinuation
    Incidence of treatment-emergent AEs, treatment-emergent SAEs, and treatment-emergent AEs/SAEs leading to treatment discontinuation
  3. Clinically significant, treatment-related laboratory abnormalities
    Incidence of clinically significant changes in laboratory tests
  4. Clinically significant, treatment-related abnormalities in vital signs
    Incidence of clinically significant changes in vital signs
  5. Clinically significant, treatment-related electrocardiogram (ECG) abnormalities
    Incidence of clinically significant changes in ECG
Secondary Outcome Measures
  1. Change from baseline in pre-bronchodilator Percent (%) Predicted FEV1 at Week 12
  2. Change from baseline in pre-bronchodilator FEV1 at all time points
  3. Change from baseline in pre-bronchodilator % Predicted FEV1 at all time points
  4. Change from baseline in pre-bronchodilator Forced Vital Capacity (FVC) at all time points
  5. Change from baseline in pre-bronchodilator % Predicted FVC at all time points
  6. Change from baseline in pre-bronchodilator FEV1/FVC Ratio at all time points
  7. Change from baseline in post-bronchodilator FEV1 at all time points
  8. Change from baseline in post-bronchodilator % Predicted FEV1 at all time points
  9. Change from baseline in post-bronchodilator FVC at all time points
  10. Change from baseline in post-bronchodilator % Predicted FVC at all time points
  11. Change from baseline in post-bronchodilator FEV1/FVC Ratio at all time points
  12. Percentage change from baseline in pre-bronchodilator FEV1 at all time points
  13. Change from baseline in pre-bronchodilator FEV1 at Week 12
  14. Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) total score at Week 12
  15. Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) global score at Week 12
  16. Change from baseline in pre-bronchodilator FEV1 at Week 12 in participants with Fractional Concentration of Exhaled Nitric Oxide (FeNO) ≥25 ppb and <25 ppb

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Must meet the following asthma criteria: 1. History of persistent, moderate-to-severe asthma for at least 12 months prior to screening. 2. Must have experienced at least 1 asthma exacerbation requiring treatment with systemic steroids (oral or parenteral) for 3 days or more within 12 months of the screening visit. 3. At least 2 of the 3 pre-bronchodilator FEV1 values collected in the run-in period and the mean of the of pre-bronchodilator FEV1 values collected in the run-in period are ≥30% to \<80% of predicted normal values. 4. Positive bronchodilator responsiveness as evidenced by increase in FEV1 of at least 12% and 200 mL for spirometry conducted during screening period. 5. Maintenance (controller) treatment that minimally includes a medium to high dose ICS - LABA combination consistent with GINA Step 4/5 (either Track 1 or Track 2) for 12 months prior to the screening visit and at a stable dose for at least 3 months prior to the screening visit. 6. ACQ-5 score of ≥1.5 at screening visit and prior to randomization. Other Inclusion Criteria: 7. Body mass index between 18 40 kg/m2 at screening.
Exclusion Criteria
Medical Conditions: 1. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 2. Evidence of lung disease(s) other than asthma, either clinical evidence, spirometry, or imaging (Chest X-ray, CT, MRI) within 12 months of the screening visit, as per local standard of care, including but not limited to: Chronic obstructive pulmonary disease, Other emphysematous lung disease such as alpha-1 antitrypsin disease, Cystic fibrosis, Emphysema, Idiopathic pulmonary fibrosis, Churg-Strauss syndrome, Allergic bronchopulmonary aspergillosis, Sarcoidosis 3. Diagnosed with any of the following acute or chronic infections or infection history:
Active helminth or parasitic infection requiring treatment within 2 weeks prior to screening;
Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1;
Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1. Prior/Concomitant Therapy: 4. Prior or current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). 5. Prior or concurrent treatment with either approved or experimental biologic treatment (such as inhibitors of IL-4, IL-13, IL-33/ST2, IL-4Rα, TSLP, IL-5, OX40/OX40L or IgE) or targeted synthetic drugs (such as JAK inhibitors) for the treatment of asthma or other type 2 inflammatory diseases, including but not limited to: AD, EoE, CRS. 6. Treatment with any dose level of systemic (oral, injectable, or intraarticular) corticosteroids within 28 days of the screening visit. 7. Prior (within 12 weeks prior to screening) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig). 8. History of anaphylaxis to antibody therapeutic or to PF-07275315 or to the excipients of the formulated drug products. 9. Bronchial thermoplasty within the previous 24 months. Prior/Concurrent Clinical Study Experience: 10. Administration of an investigational drug product within 30 days or 5 half lives preceding the screening visit (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.

Contacts and Locations

Sponsors and CollaboratorsPfizer
Locations
Velocity Clinical Research, Mobile | Mobile Alabama, United States, 36608Chandler Clinical Trials | Chandler Arizona, United States, 85224Antelope Valley Clinical Trials | Lancaster California, United States, 93534NewportNativeMD, Inc. | Newport Beach California, United States, 92663California Medical Research Associates | Northridge California, United States, 91324Allergy and Asthma Associates of Santa Clara Valley Research Center | San Jose California, United States, 95117Allergy & Asthma Clinical Research | Walnut Creek California, United States, 94598Colorado ENT & Allergy | Colorado Springs Colorado, United States, 80923Cpcc-Research Llc | East Point Georgia, United States, 30344Christie Clinic - University | Champaign Illinois, United States, 61820Innovo Research - Christie Clinic | Champaign Illinois, United States, 61820Christie Clinic - Windsor | Champaign Illinois, United States, 61822University of Kansas Medical Center | Kansas City Kansas, United States, 66160North Ingalls Building | Ann Arbor Michigan, United States, 48109University of Michigan | Ann Arbor Michigan, United States, 48109Washington University School of Medicine | St Louis Missouri, United States, 63110Henderson Clinical Trials | Henderson Nevada, United States, 89052Rutgers, Robert Wood Johnson Medical School | New Brunswick New Jersey, United States, 08901Circuit Clinical / Impact Medical Allergy, Asthma & Immunology | Riverdale New Jersey, United States, 07457American Health Research | Charlotte North Carolina, United States, 28277Clinical Research Of Gastonia | Gastonia North Carolina, United States, 28054Stern Research Partners, LLC | Huntersville North Carolina, United States, 28078Toledo Institute of Clinical Research Inc. | Toledo Ohio, United States, 43617OK Clinical Research | Edmond Oklahoma, United States, 73034Allergy, Asthma and Clinical Research | Oklahoma City Oklahoma, United States, 73120Layrek Clinical Research | Tulsa Oklahoma, United States, 74133Clinical Research Associates of Central PA, LLC | DuBois Pennsylvania, United States, 15801Clinical Research of Rock Hill | Rock Hill South Carolina, United States, 29732Premier Research Center, LLC | Hendersonville Tennessee, United States, 37075South Texas Medical Research Institute, Inc., DBA TTS Research | Boerne Texas, United States, 78006Horizon Clinical Research Group | Cypress Texas, United States, 77429Alina Clinical Trials, LLC. | Dallas Texas, United States, 75209Greater Heights & Memorial Pulmonary and Sleep | Houston Texas, United States, 77008Houston Pulmonary Sleep and Allergy Associates | Houston Texas, United States, 77065Metroplex Pulmonary and Sleep Center | McKinney Texas, United States, 75069Clinical Research Partners, LLC | Richmond Virginia, United States, 23226Fundación Respirar | Ciudad Autónoma de Buenos Aires Buenos Aires, Argentina, C1426ABPInvestigaciones en Patologias Respiratorias | San Miguel de Tucumán Tucumán Province, Argentina, 4000Centro de Investigaciones Metabólicas (CINME) | Buenos Aires , Argentina, C1056ABIFundacion Scherbovsky | Mendoza , Argentina, 5500Instituto de Salud Respiratoria | Mendoza , Argentina, 5500AZ Sint-Maarten | Mechelen Antwerpen, Belgium, 2800UZ Gent | Ghent Oost-vlaanderen, Belgium, 9000Centre Hospitalier Régional de la Citadelle | Liège , Belgium, 4000Diagnostic Consultative Center Aleksandrovska | Sofia Sofia (stolitsa), Bulgaria, 1431Medical Center Pulmo - 2018 EOOD | Haskovo , Bulgaria, 6300Medical Center Pulmovision | Sofia , Bulgaria, 1756Medical Center New Rehabilitation Center EOOD | Stara Zagora , Bulgaria, 6001Beijing Chao-Yang Hospital, Capital Medical University | Beijing Beijing Municipality, China, 100020China-Japan Friendship Hospital | Beijing Beijing Municipality, China, 100029The Third Affiliated Hospital of Guangzhou Medical University | Guangzhou Guangdong, China, 510150The First Affiliated Hospital of Baotou Medical College | Baotou Inner Mongolia, China, 014010Inner Mongolia People's Hospital | Hohhot Inner Mongolia, China, 010017The Affiliated Hospital of Inner Mongolia Medical University | Hohhot Inner Mongolia, China, 010050Nanjing First Hospital | Najing Jiangsu, China, 210001Jiangsu Province Hospital | Nanjing Jiangsu, China, 210029The Affiliated Hospital of Xuzhou Medical College | Xuzhou Jiangsu, China, 221006Xuzhou Central Hospital | Xuzhou Jiangsu, China, 221009Jiangxi Provincial People's Hospital | Nanchang Jiangxi, China, 330006The Second Hospital of Jilin University | Changchun Jilin, China, 130000The First Affiliated Hospital of Xi'an Medical University | Xi'an Shaanxi, China, 710077Shanghai General Hospital | Shanghai Shanghai Municipality, China, 200080Shanghai Pulmonary Hospital | Shanghai Shanghai Municipality, China, 200433Ruijin Hospital Shanghai Jiaotong University School of Medicine | Shanghai Shanghai Municipality, China, West China Hospital, Sichuan University | Chengdu Sichuan, China, 610041Zhejiang Provincial People's Hospital | Hangzhou Zhejiang, China, 310014The First People's Hospital of Hangzhou | Hangzhou Zhejiang, China, Taizhou Central Hospital | Taizhou Zhejiang, China, 318000Mudr.I.Cierna Peterova s.r.o. | Brandýs nad Labem Central Bohemia, Czechia, 25001MEDITRIAL s.r.o. | Jindrichuv Hradec III South Bohemian Region, Czechia, 377 01Fakultni nemocnice Hradec Kralove | Hradec Králové , Czechia, 500 05CEFISPIRO s.r.o. | Lovosice , Czechia, 410 02Koch Róbert Kórház és Rendelőintézet | Edelény Borsod-Abauj Zemplen county, Hungary, 3780Omnimodus Elixír Kft. | Mosonmagyaróvár Győr-Moson-Sopron, Hungary, 9200Szalay János Rendelőintézet | Hajdúnánás Hajdú-Bihar, Hungary, 4080Erzsebet Gondozohaz | Gödöllő Pest County, Hungary, 2100Da Vinci Magánklinika | Pécs , Hungary, 7635Policlinico Universitario Monserrato | Monserrato Cagliari, Italy, 09042IRCCS Istituto Clinico Humanitas | Rozzano Milano, Italy, 20089Azienda Ospedaliero-Universitaria San Luigi Gonzaga | Orbassano Piedmont, Italy, 10043Azienda Ospedaliero Universitaria Senese | Siena Tuscany, Italy, 53100Azienda Ospedaliera Ordine Mauriziano di Torino | Torino , Italy, 10128Mazda Hospital | Aki-gun Fuchu-cho Hiroshima, Japan, 735-8585Kobe City Medical Center West Hospital | Kobe Hyōgo, Japan, 653-0013National Hospital Organization Osaka Minami Medical Center | Kawachi-Nagano Osaka, Japan, 586-8521NHO Kinki Chuo Chest Medical Center | Sakai Osaka, Japan, 591-8555Fujieda Municipal General Hospital | Fujieda Shizuoka, Japan, 426-8677Hamamatsu Rosai Hospital | Hamamatsu Shizuoka, Japan, 430-8525Fukuwa Clinic | Chuo-ku Tokyo, Japan, 104-0031Tokyo Medical University Hachioji Medical Center | Hachiōji Tokyo, Japan, 1930998Fukuoka National Hospital | Fukuoka , Japan, 811-1394Hiroshima Prefectural Hospital | Hiroshima , Japan, 734-0004Alergologia Plus sp. z o.o. | Poznan Greater Poland Voivodeship, Poland, 60-693Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o | Poznan Greater Poland Voivodeship, Poland, 61-578Małopolskie Centrum Alergologii | Krakow Lesser Poland Voivodeship, Poland, 31-624ALERGO-MED OŚRODEK BADAŃ KLINICZNYCH Sp. z o.o. | Tarnów Lesser Poland Voivodeship, Poland, 33-100Dobrostan Gabinet Lekarskie | Wroclaw Lower Silesian Voivodeship, Poland, 53-301KLIMED Marek Klimkiewicz | Bychawa Lublin Voivodeship, Poland, 18-404PULMAG s.c. | Sosnowiec Silesian Voivodeship, Poland, 41-208Jeonbuk National University Hospital | Jeonju Jeonrabugdo, South Korea, 54907Yeungnam University hospital | Daegu Kyǒngsangbuk-do, South Korea, 42415The Catholic University of Korea, Eunpyeong St. Mary's Hospital | Seoul Seoul-teukbyeolsi [seoul], South Korea, 03312Severance Hospital, Yonsei University Health System | Seoul Seoul-teukbyeolsi [seoul], South Korea, 03722Konkuk University Medical Center | Seoul Seoul-teukbyeolsi [seoul], South Korea, 05030Asan Medical Center | Seoul Seoul-teukbyeolsi [seoul], South Korea, 05505Samsung Medical Center | Seoul Seoul-teukbyeolsi [seoul], South Korea, 06351The Catholic Univ. of Korea Seoul St. Mary's Hospital | Seoul Seoul-teukbyeolsi [seoul], South Korea, 06591Korea University Guro Hospital | Seoul Seoul-teukbyeolsi [seoul], South Korea, 08308Yeungnam Univeristy Medical Center | Daegu Taegu-kwangyǒkshi, South Korea, 42415Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón Madrid, Spain, 28223Hospital Universitario La Paz | Madrid Madrid, Comunidad de, Spain, 28046Hospital Universitario Virgen de la Victoria | Málaga Málaga, Spain, 29010Changhua Christian Hospital | Changhua County Changhua, Taiwan, 50006Far Eastern Memorial Hospital | New Taipei City NEW Taipei, Taiwan, 220Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City , Taiwan, 807Taichung Veterans General Hospital | Taichung , Taiwan, 407National Taiwan University Hospital | Taipei , Taiwan, 10002Chang Gung Medical Foundation-Linkou Branch | Taoyuan District , Taiwan, 333Outpatients | Cambridge Cambridgeshire, United Kingdom, cb2 0qqAddenbrooke's Hospital | Cambridge Cambridgeshire, United Kingdom, CB2 2QQWythenshawe Hospital | Manchester Greater Manchester, United Kingdom, M23 9LTHammersmith Hospital | London London, CITY of, United Kingdom, W12 0HSBradford Royal Infirmary | Bradford , United Kingdom, BD9 6RJNorth Manchester General Hospital | Crumpsall , United Kingdom, M8 5RBPinderfields General Hospital | Wakefield , United Kingdom, WF1 4DG
Investigators
Study Director: Pfizer CT.gov Call Center, Pfizer