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NCT06977581PHASE2Recruiting

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

Pfizer

Start Date

5/20/2025

Completion Date

5/31/2027

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.

Eligibility Criteria

Age Range: 18 years to 70 years

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.

Interventions

DRUG

PF-07275315

OTHER

Placebo

Interested in This Trial?

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Conditions

Asthma

Locations

Velocity Clinical Research, Mobile

Mobile, Alabama 36608

United States

Chandler Clinical Trials

Chandler, Arizona 85224

United States

Antelope Valley Clinical Trials

Lancaster, California 93534

United States

NewportNativeMD, Inc.

Newport Beach, California 92663

United States

California Medical Research Associates

Northridge, California 91324

United States

Allergy and Asthma Associates of Santa Clara Valley Research Center

San Jose, California 95117

United States

Allergy & Asthma Clinical Research

Walnut Creek, California 94598

United States

Colorado ENT & Allergy

Colorado Springs, Colorado 80923

United States

Cpcc-Research Llc

East Point, Georgia 30344

United States

Christie Clinic - University

Champaign, Illinois 61820

United States

Innovo Research - Christie Clinic

Champaign, Illinois 61820

United States

Christie Clinic - Windsor

Champaign, Illinois 61822

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

North Ingalls Building

Ann Arbor, Michigan 48109

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Henderson Clinical Trials

Henderson, Nevada 89052

United States

Rutgers, Robert Wood Johnson Medical School

New Brunswick, New Jersey 08901

United States

Circuit Clinical / Impact Medical Allergy, Asthma & Immunology

Riverdale, New Jersey 07457

United States

American Health Research

Charlotte, North Carolina 28277

United States

Clinical Research Of Gastonia

Gastonia, North Carolina 28054

United States

Stern Research Partners, LLC

Huntersville, North Carolina 28078

United States

Toledo Institute of Clinical Research Inc.

Toledo, Ohio 43617

United States

OK Clinical Research

Edmond, Oklahoma 73034

United States

Allergy, Asthma and Clinical Research

Oklahoma City, Oklahoma 73120

United States

Layrek Clinical Research

Tulsa, Oklahoma 74133

United States

Clinical Research Associates of Central PA, LLC

DuBois, Pennsylvania 15801

United States

Clinical Research of Rock Hill

Rock Hill, South Carolina 29732

United States

Premier Research Center, LLC

Hendersonville, Tennessee 37075

United States

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

Boerne, Texas 78006

United States

Horizon Clinical Research Group

Cypress, Texas 77429

United States

Alina Clinical Trials, LLC.

Dallas, Texas 75209

United States

Greater Heights & Memorial Pulmonary and Sleep

Houston, Texas 77008

United States

Houston Pulmonary Sleep and Allergy Associates

Houston, Texas 77065

United States

Metroplex Pulmonary and Sleep Center

McKinney, Texas 75069

United States

Clinical Research Partners, LLC

Richmond, Virginia 23226

United States

Fundación Respirar

Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ABP

Argentina

Instituto Ave Pulmo

Mar del Plata, Buenos Aires 7600

Argentina

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, Tucumán Province 4000

Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, C1056ABI

Argentina

Fundacion Scherbovsky

Mendoza, 5500

Argentina

Instituto de Salud Respiratoria

Mendoza, 5500

Argentina

AZ Sint-Maarten

Mechelen, Antwerpen 2800

Belgium

UZ Gent

Ghent, Oost-vlaanderen 9000

Belgium

Centre Hospitalier Régional de la Citadelle

Liège, 4000

Belgium

Diagnostic Consultative Center Aleksandrovska

Sofia, Sofia (stolitsa) 1431

Bulgaria

Medical Center Pulmo - 2018 EOOD

Haskovo, 6300

Bulgaria

Medical Center Pulmovision

Sofia, 1756

Bulgaria

Medical Center New Rehabilitation Center EOOD

Stara Zagora, 6001

Bulgaria

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality 100020

China

China-Japan Friendship Hospital

Beijing, Beijing Municipality 100029

China

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong 510150

China

The First Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia 014010

China

Inner Mongolia People's Hospital

Hohhot, Inner Mongolia 010017

China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia 010050

China

Nanjing First Hospital

Najing, Jiangsu 210001

China

Jiangsu Province Hospital

Nanjing, Jiangsu 210029

China

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, Jiangsu 221006

China

Xuzhou Central Hospital

Xuzhou, Jiangsu 221009

China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi 330006

China

The Second Hospital of Jilin University

Changchun, Jilin 130000

China

The First Affiliated Hospital of Xi'an Medical University

Xi'an, Shaanxi 710077

China

Shanghai General Hospital

Shanghai, Shanghai Municipality 200080

China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality 200433

China

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality

China

West China Hospital, Sichuan University

Chengdu, Sichuan 610041

China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang 310014

China

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang

China

Taizhou Central Hospital

Taizhou, Zhejiang 318000

China

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

Brandýs nad Labem, Central Bohemia 25001

Czechia

MEDITRIAL s.r.o.

Jindrichuv Hradec III, South Bohemian Region 377 01

Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05

Czechia

CEFISPIRO s.r.o.

Lovosice, 410 02

Czechia

Koch Róbert Kórház és Rendelőintézet

Edelény, Borsod-Abauj Zemplen county 3780

Hungary

Omnimodus Elixír Kft.

Mosonmagyaróvár, Győr-Moson-Sopron 9200

Hungary

Szalay János Rendelőintézet

Hajdúnánás, Hajdú-Bihar 4080

Hungary

Erzsebet Gondozohaz

Gödöllő, Pest County 2100

Hungary

Da Vinci Magánklinika

Pécs, 7635

Hungary

Policlinico Universitario Monserrato

Monserrato, Cagliari 09042

Italy

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

Reggio Emilia, Emilia-Romagna 42123

Italy

IRCCS Istituto Clinico Humanitas

Rozzano, Milano 20089

Italy

Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Orbassano, Piedmont 10043

Italy

Azienda Ospedaliero Universitaria Senese

Siena, Tuscany 53100

Italy

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, 10128

Italy

Mazda Hospital

Aki-gun Fuchu-cho, Hiroshima 735-8585

Japan

Kobe City Medical Center West Hospital

Kobe, Hyōgo 653-0013

Japan

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, Osaka 586-8521

Japan

NHO Kinki Chuo Chest Medical Center

Sakai, Osaka 591-8555

Japan

Fujieda Municipal General Hospital

Fujieda, Shizuoka 426-8677

Japan

Hamamatsu Rosai Hospital

Hamamatsu, Shizuoka 430-8525

Japan

Fukuwa Clinic

Chuo-ku, Tokyo 104-0031

Japan

Tokyo Medical University Hachioji Medical Center

Hachiōji, Tokyo 1930998

Japan

Fukuoka National Hospital

Fukuoka, 811-1394

Japan

Hiroshima Prefectural Hospital

Hiroshima, 734-0004

Japan

Alergologia Plus sp. z o.o.

Poznan, Greater Poland Voivodeship 60-693

Poland

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

Poznan, Greater Poland Voivodeship 61-578

Poland

Małopolskie Centrum Alergologii

Krakow, Lesser Poland Voivodeship 31-624

Poland

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

Tarnów, Lesser Poland Voivodeship 33-100

Poland

Dobrostan Gabinet Lekarskie

Wroclaw, Lower Silesian Voivodeship 53-301

Poland

KLIMED Marek Klimkiewicz

Bychawa, Lublin Voivodeship 23-100

Poland

PULMAG s.c.

Sosnowiec, Silesian Voivodeship 41-208

Poland

St. Augustine's Medical Centre 2

Durban, KwaZulu-Natal 4001

South Africa

Synapta Clinical Research Centre

Durban, KwaZulu-Natal 4001

South Africa

Durban International Clinical Research Site, Enhancing Care Foundation

Durban, KwaZulu-Natal 4301

South Africa

Jeonbuk National University Hospital

Jeonju, Jeonrabugdo 54907

South Korea

Yeungnam University hospital

Daegu, Kyǒngsangbuk-do 42415

South Korea

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

Seoul, Seoul-teukbyeolsi [seoul] 03312

South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul] 03722

South Korea

Konkuk University Medical Center

Seoul, Seoul-teukbyeolsi [seoul] 05030

South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi [seoul] 05505

South Korea

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [seoul] 06351

South Korea

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

Seoul, Seoul-teukbyeolsi [seoul] 06591

South Korea

Korea University Guro Hospital

Seoul, Seoul-teukbyeolsi [seoul] 08308

South Korea

Yeungnam Univeristy Medical Center

Daegu, Taegu-kwangyǒkshi 42415

South Korea

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria 39008

Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid 28223

Spain

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de 28046

Spain

Hospital Universitario Virgen de la Victoria

Málaga, Málaga 29010

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Changhua Christian Hospital

Changhua County, Changhua 50006

Taiwan

Far Eastern Memorial Hospital

New Taipei City, NEW Taipei 220

Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807

Taiwan

Taichung Veterans General Hospital

Taichung, 407

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333

Taiwan

Outpatients

Cambridge, Cambridgeshire cb2 0qq

United Kingdom

Addenbrooke's Hospital

Cambridge, Cambridgeshire CB2 2QQ

United Kingdom

Wythenshawe Hospital

Manchester, Greater Manchester M23 9LT

United Kingdom

Hammersmith Hospital

London, London, CITY of W12 0HS

United Kingdom

Bradford Royal Infirmary

Bradford, BD9 6RJ

United Kingdom

North Manchester General Hospital

Crumpsall, M8 5RB

United Kingdom

Pinderfields General Hospital

Wakefield, WF1 4DG

United Kingdom