Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06977581

PHASE2

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

Official title: A 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

252

Start Date

2025-05-20

Completion Date

2027-05-31

Last Updated

2026-02-18

Healthy Volunteers

Conditions

Asthma

Interventions

DRUG

PF-07275315

subcutaneous injection

OTHER

Placebo

subcutaneous injection

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.

Locations (125)

Velocity Clinical Research, Mobile

Mobile, Alabama, United States

Chandler Clinical Trials

Chandler, Arizona, United States

Antelope Valley Clinical Trials

Lancaster, California, United States

NewportNativeMD, Inc.

Newport Beach, California, United States

California Medical Research Associates

Northridge, California, United States

Allergy and Asthma Associates of Santa Clara Valley Research Center

San Jose, California, United States

Allergy & Asthma Clinical Research

Walnut Creek, California, United States

Colorado ENT & Allergy

Colorado Springs, Colorado, United States

Cpcc-Research Llc

East Point, Georgia, United States

Christie Clinic - University

Champaign, Illinois, United States

Innovo Research - Christie Clinic

Champaign, Illinois, United States

Christie Clinic - Windsor

Champaign, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

North Ingalls Building

Ann Arbor, Michigan, United States

University of Michigan

Ann Arbor, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Henderson Clinical Trials

Henderson, Nevada, United States

Rutgers, Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Circuit Clinical / Impact Medical Allergy, Asthma & Immunology

Riverdale, New Jersey, United States

American Health Research

Charlotte, North Carolina, United States

Clinical Research Of Gastonia

Gastonia, North Carolina, United States

Stern Research Partners, LLC

Huntersville, North Carolina, United States

Toledo Institute of Clinical Research Inc.

Toledo, Ohio, United States

OK Clinical Research

Edmond, Oklahoma, United States

Allergy, Asthma and Clinical Research

Oklahoma City, Oklahoma, United States

Layrek Clinical Research

Tulsa, Oklahoma, United States

Clinical Research Associates of Central PA, LLC

DuBois, Pennsylvania, United States

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States

Premier Research Center, LLC

Hendersonville, Tennessee, United States

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

Boerne, Texas, United States

Horizon Clinical Research Group

Cypress, Texas, United States

Alina Clinical Trials, LLC.

Dallas, Texas, United States

Greater Heights & Memorial Pulmonary and Sleep

Houston, Texas, United States

Houston Pulmonary Sleep and Allergy Associates

Houston, Texas, United States

Metroplex Pulmonary and Sleep Center

McKinney, Texas, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

Fundación Respirar

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, Tucumán Province, Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

Fundacion Scherbovsky

Mendoza, Argentina

Instituto de Salud Respiratoria

Mendoza, Argentina

AZ Sint-Maarten

Mechelen, Antwerpen, Belgium

UZ Gent

Ghent, Oost-vlaanderen, Belgium

Centre Hospitalier Régional de la Citadelle

Liège, Belgium

Diagnostic Consultative Center Aleksandrovska

Sofia, Sofia (stolitsa), Bulgaria

Medical Center Pulmo - 2018 EOOD

Haskovo, Bulgaria

Medical Center Pulmovision

Sofia, Bulgaria

Medical Center New Rehabilitation Center EOOD

Stara Zagora, Bulgaria

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, China

Inner Mongolia People's Hospital

Hohhot, Inner Mongolia, China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Nanjing First Hospital

Najing, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

The Second Hospital of Jilin University

Changchun, Jilin, China

The First Affiliated Hospital of Xi'an Medical University

Xi'an, Shaanxi, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, China

Taizhou Central Hospital

Taizhou, Zhejiang, China

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

Brandýs nad Labem, Central Bohemia, Czechia

MEDITRIAL s.r.o.

Jindrichuv Hradec III, Jihočeský kraj, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

CEFISPIRO s.r.o.

Lovosice, Czechia

Koch Róbert Kórház és Rendelőintézet

Edelény, Borsod-Abauj Zemplen county, Hungary

Omnimodus Elixír Kft.

Mosonmagyaróvár, Győr-Moson-Sopron, Hungary

Szalay János Rendelőintézet

Hajdúnánás, Hajdú-Bihar, Hungary

Erzsebet Gondozohaz

Gödöllő, Pest County, Hungary

Da Vinci Magánklinika

Pécs, Hungary

Policlinico Universitario Monserrato

Monserrato, Cagliari, Italy

IRCCS Istituto Clinico Humanitas

Rozzano, Milano, Italy

Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Orbassano, Piedmont, Italy

Azienda Ospedaliero Universitaria Senese

Siena, Tuscany, Italy

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, Italy

Mazda Hospital

Aki-gun Fuchu-cho, Hiroshima, Japan

Kobe City Medical Center West Hospital

Kobe, Hyōgo, Japan

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, Osaka, Japan

NHO Kinki Chuo Chest Medical Center

Sakai, Osaka, Japan

Fujieda Municipal General Hospital

Fujieda, Shizuoka, Japan

Hamamatsu Rosai Hospital

Hamamatsu, Shizuoka, Japan

Fukuwa Clinic

Chuo-ku, Tokyo, Japan

Tokyo Medical University Hachioji Medical Center

Hachiōji, Tokyo, Japan

Fukuoka National Hospital

Fukuoka, Japan

Hiroshima Prefectural Hospital

Hiroshima, Japan

Alergologia Plus sp. z o.o.

Poznan, Greater Poland Voivodeship, Poland

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

Poznan, Greater Poland Voivodeship, Poland

Małopolskie Centrum Alergologii

Krakow, Lesser Poland Voivodeship, Poland

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

Tarnów, Lesser Poland Voivodeship, Poland

Dobrostan Gabinet Lekarskie

Wroclaw, Lower Silesian Voivodeship, Poland

KLIMED Marek Klimkiewicz

Bychawa, Lublin Voivodeship, Poland

PULMAG s.c.

Sosnowiec, Silesian Voivodeship, Poland

Jeonbuk National University Hospital

Jeonju, Jeonrabugdo, South Korea

Yeungnam University hospital

Daegu, Kyǒngsangbuk-do, South Korea

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