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

NCT06977581 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: C45310292024-517866-40-00
• Study Type: interventional
• Target: 252
• Locations: 15 countries
• Sites: 132

Brief Summary

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) for the potential treatment of moderate-to-severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life and functioning of people who are affected. This study is seeking participants who:

• Are 18 to 70 years old
• Have had moderate-to-severe asthma for at least 12 months that is not well controlled
• Have been taking their regular maintenance treatment(s) for asthma over the last 12 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 12 weeks. We will compare the experiences 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 will be involved in this study for about 7.5 months. During this time, they will have 9 visits at the study clinic.

Conditions

Asthma

Keywords

Pulmonary; Wheezing; Respiratory hypersensitivity; Airway Inflammation; Airway Obstruction; Dyspnea; Lung Diseases; Respiratory Tract Diseases; Asthma

Outcome Measures

Primary Outcomes (5)

• 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.

  Week 12

• 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

  Baseline through Week 24

• Clinically significant, treatment-related laboratory abnormalities

  Incidence of clinically significant changes in laboratory tests

  Baseline through Week 24

• Clinically significant, treatment-related abnormalities in vital signs

  Incidence of clinically significant changes in vital signs

  Baseline through Week 24

• Clinically significant, treatment-related electrocardiogram (ECG) abnormalities

  Incidence of clinically significant changes in ECG

  Baseline through Week 24

Secondary Outcomes (16)

• Change from baseline in pre-bronchodilator Percent (%) Predicted FEV1 at Week 12

  Week 12

• Change from baseline in pre-bronchodilator FEV1 at all time points

  Baseline through Week 24

• Change from baseline in pre-bronchodilator % Predicted FEV1 at all time points

  Baseline through Week 24

• Change from baseline in pre-bronchodilator Forced Vital Capacity (FVC) at all time points

  Baseline through Week 24

• Change from baseline in pre-bronchodilator % Predicted FVC at all time points

  Baseline through Week 24

Study Arms (4)

Treatment Arm A

EXPERIMENTAL

PF-07275315

Drug: PF-07275315

Treatment Arm B

EXPERIMENTAL

PF-07275315

Drug: PF-07275315

Treatment Arm C

EXPERIMENTAL

PF-07275315

Drug: PF-07275315

Treatment Arm D

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

PF-07275315 DRUG

subcutaneous injection

Treatment Arm A; Treatment Arm B; Treatment Arm C

Placebo OTHER

subcutaneous injection

Treatment Arm D

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must meet the following asthma criteria:
• History of persistent, moderate-to-severe asthma for at least 12 months prior to screening.
• 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.
• 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.
• Positive bronchodilator responsiveness as evidenced by increase in FEV1 of at least 12% and 200 mL for spirometry conducted during screening period.
• 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.
• ACQ-5 score of ≥1.5 at screening visit and prior to randomization.
• Body mass index between 18 40 kg/m2 at screening.

You may not qualify if:

• Medical Conditions:
• 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.
• 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
• 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:
• Prior or current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
• 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.
• Treatment with any dose level of systemic (oral, injectable, or intraarticular) corticosteroids within 28 days of the screening visit.
• Prior (within 12 weeks prior to screening) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig).
• History of anaphylaxis to antibody therapeutic or to PF-07275315 or to the excipients of the formulated drug products.
• Bronchial thermoplasty within the previous 24 months.
• Prior/Concurrent Clinical Study Experience:

Sponsors & Collaborators

• Pfizer: lead

Study Sites (132)

Velocity Clinical Research, Mobile

Mobile, Alabama, 36608, United States

RECRUITING

Chandler Clinical Trials

Chandler, Arizona, 85224, United States

RECRUITING

Antelope Valley Clinical Trials

Lancaster, California, 93534, United States

RECRUITING

NewportNativeMD, Inc.

Newport Beach, California, 92663, United States

RECRUITING

California Medical Research Associates

Northridge, California, 91324, United States

RECRUITING

Allergy and Asthma Associates of Santa Clara Valley Research Center

San Jose, California, 95117, United States

RECRUITING

Allergy & Asthma Clinical Research

Walnut Creek, California, 94598, United States

RECRUITING

Colorado ENT & Allergy

Colorado Springs, Colorado, 80923, United States

RECRUITING

Cpcc-Research Llc

East Point, Georgia, 30344, United States

NOT YET RECRUITING

Christie Clinic - University

Champaign, Illinois, 61820, United States

RECRUITING

Innovo Research - Christie Clinic

Champaign, Illinois, 61820, United States

RECRUITING

Christie Clinic - Windsor

Champaign, Illinois, 61822, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

North Ingalls Building

Ann Arbor, Michigan, 48109, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Henderson Clinical Trials

Henderson, Nevada, 89052, United States

RECRUITING

Rutgers, Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

RECRUITING

Circuit Clinical / Impact Medical Allergy, Asthma & Immunology

Riverdale, New Jersey, 07457, United States

RECRUITING

American Health Research

Charlotte, North Carolina, 28277, United States

RECRUITING

Clinical Research Of Gastonia

Gastonia, North Carolina, 28054, United States

NOT YET RECRUITING

Stern Research Partners, LLC

Huntersville, North Carolina, 28078, United States

RECRUITING

Toledo Institute of Clinical Research Inc.

Toledo, Ohio, 43617, United States

RECRUITING

OK Clinical Research

Edmond, Oklahoma, 73034, United States

RECRUITING

Allergy, Asthma and Clinical Research

Oklahoma City, Oklahoma, 73120, United States

NOT YET RECRUITING

Layrek Clinical Research

Tulsa, Oklahoma, 74133, United States

RECRUITING

Clinical Research Associates of Central PA, LLC

DuBois, Pennsylvania, 15801, United States

RECRUITING

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States

RECRUITING

Premier Research Center, LLC

Hendersonville, Tennessee, 37075, United States

RECRUITING

South Texas Medical Research Institute, Inc., DBA TTS Research

Boerne, Texas, 78006, United States

RECRUITING

Horizon Clinical Research Group

Cypress, Texas, 77429, United States

RECRUITING

Alina Clinical Trials, LLC.

Dallas, Texas, 75209, United States

RECRUITING

Greater Heights & Memorial Pulmonary and Sleep

Houston, Texas, 77008, United States

RECRUITING

Houston Pulmonary Sleep and Allergy Associates

Houston, Texas, 77065, United States

RECRUITING

Metroplex Pulmonary and Sleep Center

McKinney, Texas, 75069, United States

ACTIVE NOT RECRUITING

Clinical Research Partners, LLC

Richmond, Virginia, 23226, United States

RECRUITING

Fundación Respirar

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina

RECRUITING

Instituto Ave Pulmo

Mar del Plata, Buenos Aires, 7600, Argentina

RECRUITING

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

RECRUITING

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, C1056ABI, Argentina

RECRUITING

Fundacion Scherbovsky

Mendoza, 5500, Argentina

RECRUITING

Instituto de Salud Respiratoria

Mendoza, 5500, Argentina

RECRUITING

AZ Sint-Maarten

Mechelen, Antwerpen, 2800, Belgium

RECRUITING

UZ Gent

Ghent, Oost-vlaanderen, 9000, Belgium

RECRUITING

Centre Hospitalier Régional de la Citadelle

Liège, 4000, Belgium

RECRUITING

Diagnostic Consultative Center Aleksandrovska

Sofia, Sofia (stolitsa), 1431, Bulgaria

RECRUITING

Medical Center Pulmo - 2018 EOOD

Haskovo, 6300, Bulgaria

RECRUITING

Medical Center Pulmovision

Sofia, 1756, Bulgaria

RECRUITING

Medical Center New Rehabilitation Center EOOD

Stara Zagora, 6001, Bulgaria

RECRUITING

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

NOT YET RECRUITING

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510150, China

RECRUITING

The First Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, 014010, China

NOT YET RECRUITING

Inner Mongolia People's Hospital

Hohhot, Inner Mongolia, 010017, China

RECRUITING

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 010050, China

RECRUITING

Nanjing First Hospital

Najing, Jiangsu, 210001, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, Jiangsu, 221006, China

RECRUITING

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

NOT YET RECRUITING

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330006, China

RECRUITING

The Second Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

The First Affiliated Hospital of Xi'an Medical University

Xi'an, Shaanxi, 710077, China

RECRUITING

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

NOT YET RECRUITING

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

RECRUITING

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Taizhou Central Hospital

Taizhou, Zhejiang, 318000, China

NOT YET RECRUITING

Mudr.I.Cierna Peterova s.r.o.

Brandýs nad Labem, Central Bohemia, 25001, Czechia

RECRUITING

MEDITRIAL s.r.o.

Jindrichuv Hradec III, South Bohemian Region, 377 01, Czechia

RECRUITING

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

RECRUITING

CEFISPIRO s.r.o.

Lovosice, 410 02, Czechia

RECRUITING

Koch Róbert Kórház és Rendelőintézet

Edelény, Borsod-Abauj Zemplen county, 3780, Hungary

RECRUITING

Omnimodus Elixír Kft.

Mosonmagyaróvár, Győr-Moson-Sopron, 9200, Hungary

RECRUITING

Szalay János Rendelőintézet

Hajdúnánás, Hajdú-Bihar, 4080, Hungary

RECRUITING

Erzsebet Gondozohaz

Gödöllő, Pest County, 2100, Hungary

RECRUITING

Da Vinci Magánklinika

Pécs, 7635, Hungary

RECRUITING

Policlinico Universitario Monserrato

Monserrato, Cagliari, 09042, Italy

RECRUITING

Azienda USL Reggio Emilia - Arcispedale Santa Maria Nuova (ASMN) - IRCCS

Reggio Emilia, Emilia-Romagna, 42123, Italy

RECRUITING

IRCCS Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

RECRUITING

Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Orbassano, Piedmont, 10043, Italy

RECRUITING

Azienda Ospedaliero Universitaria Senese

Siena, Tuscany, 53100, Italy

RECRUITING

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, 10128, Italy

RECRUITING

Mazda Hospital

Aki-gun Fuchu-cho, Hiroshima, 735-8585, Japan

RECRUITING

Kobe City Medical Center West Hospital

Kobe, Hyōgo, 653-0013, Japan

RECRUITING

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, Osaka, 586-8521, Japan

RECRUITING

NHO Kinki Chuo Chest Medical Center

Sakai, Osaka, 591-8555, Japan

RECRUITING

Fujieda Municipal General Hospital

Fujieda, Shizuoka, 426-8677, Japan

RECRUITING

Hamamatsu Rosai Hospital

Hamamatsu, Shizuoka, 430-8525, Japan

RECRUITING

Fukuwa Clinic

Chuo-ku, Tokyo, 104-0031, Japan

RECRUITING

Tokyo Medical University Hachioji Medical Center

Hachiōji, Tokyo, 1930998, Japan

RECRUITING

Fukuoka National Hospital

Fukuoka, 811-1394, Japan

RECRUITING

Hiroshima Prefectural Hospital

Hiroshima, 734-0004, Japan

RECRUITING

Alergologia Plus sp. z o.o.

Poznan, Greater Poland Voivodeship, 60-693, Poland

RECRUITING

Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o

Poznan, Greater Poland Voivodeship, 61-578, Poland

RECRUITING

Małopolskie Centrum Alergologii

Krakow, Lesser Poland Voivodeship, 31-624, Poland

RECRUITING

ALERGO-MED OŚRODEK BADAŃ KLINICZNYCH Sp. z o.o.

Tarnów, Lesser Poland Voivodeship, 33-100, Poland

RECRUITING

Dobrostan Gabinet Lekarskie

Wroclaw, Lower Silesian Voivodeship, 53-301, Poland

RECRUITING

KLIMED Marek Klimkiewicz

Bychawa, Lublin Voivodeship, 23-100, Poland

RECRUITING

PULMAG s.c.

Sosnowiec, Silesian Voivodeship, 41-208, Poland

RECRUITING

St. Augustine's Medical Centre 2

Durban, KwaZulu-Natal, 4001, South Africa

NOT YET RECRUITING

Synapta Clinical Research Centre

Durban, KwaZulu-Natal, 4001, South Africa

NOT YET RECRUITING

Durban International Clinical Research Site, Enhancing Care Foundation

Durban, KwaZulu-Natal, 4301, South Africa

NOT YET RECRUITING

Jeonbuk National University Hospital

Jeonju, Jeonrabugdo, 54907, South Korea

RECRUITING

Yeungnam University hospital

Daegu, Kyǒngsangbuk-do, 42415, South Korea

RECRUITING

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, Seoul-teukbyeolsi [seoul], 03312, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea

RECRUITING

Konkuk University Medical Center

Seoul, Seoul-teukbyeolsi [seoul], 05030, South Korea

RECRUITING

Asan Medical Center

Seoul, Seoul-teukbyeolsi [seoul], 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea

RECRUITING

The Catholic Univ. of Korea Seoul St. Mary's Hospital

Seoul, Seoul-teukbyeolsi [seoul], 06591, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, Seoul-teukbyeolsi [seoul], 08308, South Korea

RECRUITING

Yeungnam Univeristy Medical Center

Daegu, Taegu-kwangyǒkshi, 42415, South Korea

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

NOT YET RECRUITING

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

NOT YET RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de, 28046, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, 29010, Spain

NOT YET RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

NOT YET RECRUITING

Changhua Christian Hospital

Changhua County, Changhua, 50006, Taiwan

RECRUITING

Far Eastern Memorial Hospital

New Taipei City, NEW Taipei, 220, Taiwan

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, 407, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333, Taiwan

RECRUITING

Outpatients

Cambridge, Cambridgeshire, cb2 0qq, United Kingdom

RECRUITING

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

RECRUITING

Wythenshawe Hospital

Manchester, Greater Manchester, M23 9LT, United Kingdom

RECRUITING

Hammersmith Hospital

London, London, CITY of, W12 0HS, United Kingdom

NOT YET RECRUITING

Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

NOT YET RECRUITING

North Manchester General Hospital

Crumpsall, M8 5RB, United Kingdom

RECRUITING

Pinderfields General Hospital

Wakefield, WF1 4DG, United Kingdom

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Asthma; Respiratory Sounds; Respiratory Hypersensitivity; Airway Obstruction; Dyspnea; Lung Diseases; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Bronchial Diseases; Lung Diseases, Obstructive; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 18, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): March 8, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

ES (5); BU (4); TW (6); GB (7); AR (6); BE (3); CZ (4); HU (5); PL (7); CN (20); IT (6); KR (10); ZA (3); US (36); JP (10)