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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

Status: Recruiting
Location: See all (121) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

⁃ 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.

• Other Inclusion Criteria:

• Body mass index between 18 40 kg/m2 at screening.

Locations
United States
Alabama
Velocity Clinical Research, Mobile
RECRUITING
Mobile
Arizona
Chandler Clinical Trials
RECRUITING
Chandler
California
Antelope Valley Clinical Trials
RECRUITING
Lancaster
NewportNativeMD, Inc.
RECRUITING
Newport Beach
California Medical Research Associates
RECRUITING
Northridge
Allergy and Asthma Associates of Santa Clara Valley Research Center
RECRUITING
San Jose
Allergy & Asthma Clinical Research
RECRUITING
Walnut Creek
Colorado
Colorado ENT & Allergy
RECRUITING
Colorado Springs
Georgia
Cpcc-Research Llc
NOT_YET_RECRUITING
East Point
Illinois
Christie Clinic - University
RECRUITING
Champaign
Christie Clinic - Windsor
RECRUITING
Champaign
Innovo Research - Christie Clinic
RECRUITING
Champaign
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Michigan
North Ingalls Building
NOT_YET_RECRUITING
Ann Arbor
University of Michigan
NOT_YET_RECRUITING
Ann Arbor
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
American Health Research
RECRUITING
Charlotte
Clinical Research Of Gastonia
NOT_YET_RECRUITING
Gastonia
Stern Research Partners, LLC
NOT_YET_RECRUITING
Huntersville
New Jersey
Rutgers, Robert Wood Johnson Medical School
RECRUITING
New Brunswick
Circuit Clinical / Impact Medical Allergy, Asthma & Immunology
RECRUITING
Riverdale
Nevada
Henderson Clinical Trials
RECRUITING
Henderson
Ohio
Toledo Institute of Clinical Research Inc.
RECRUITING
Toledo
Oklahoma
OK Clinical Research
RECRUITING
Edmond
Allergy, Asthma and Clinical Research
NOT_YET_RECRUITING
Oklahoma City
Layrek Clinical Research
RECRUITING
Tulsa
Pennsylvania
Clinical Research Associates of Central PA, LLC
RECRUITING
Dubois
South Carolina
Clinical Research of Rock Hill
RECRUITING
Rock Hill
Tennessee
Premier Research Center, LLC
RECRUITING
Hendersonville
Texas
South Texas Medical Research Institute, Inc., DBA TTS Research
RECRUITING
Boerne
Horizon Clinical Research Group
RECRUITING
Cypress
Alina Clinical Trials, LLC.
RECRUITING
Dallas
Greater Heights & Memorial Pulmonary and Sleep
RECRUITING
Houston
Houston Pulmonary Sleep and Allergy Associates
RECRUITING
Houston
Metroplex Pulmonary and Sleep Center
RECRUITING
Mckinney
Virginia
Clinical Research Partners, LLC
NOT_YET_RECRUITING
Richmond
Other Locations
Argentina
Centro de Investigaciones Metabólicas (CINME)
NOT_YET_RECRUITING
Buenos Aires
Fundación Respirar
NOT_YET_RECRUITING
Ciudad Autónoma De Buenos Aires
Fundacion Scherbovsky
RECRUITING
Mendoza
Instituto de Salud Respiratoria
RECRUITING
Mendoza
Investigaciones en Patologias Respiratorias
RECRUITING
San Miguel De Tucumán
Belgium
UZ Gent
RECRUITING
Ghent
Centre Hospitalier Régional de la Citadelle
NOT_YET_RECRUITING
Liège
AZ Sint-Maarten
RECRUITING
Mechelen
Bulgaria
Medical Center Pulmo - 2018 EOOD
RECRUITING
Haskovo
Diagnostic Consultative Center Aleksandrovska
RECRUITING
Sofia
Medical Center Pulmovision
RECRUITING
Sofia
Medical Center New Rehabilitation Center EOOD
RECRUITING
Stara Zagora
China
The First Affiliated Hospital of Baotou Medical College
NOT_YET_RECRUITING
Baotou
Beijing Chao-Yang Hospital, Capital Medical University
RECRUITING
Beijing
China-Japan Friendship Hospital
NOT_YET_RECRUITING
Beijing
The Second Hospital of Jilin University
RECRUITING
Changchun
West China Hospital, Sichuan University
NOT_YET_RECRUITING
Chengdu
The Third Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
The First People's Hospital of Hangzhou
NOT_YET_RECRUITING
Hangzhou
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Inner Mongolia People's Hospital
RECRUITING
Hohhot
The Affiliated Hospital of Inner Mongolia Medical University
RECRUITING
Hohhot
Nanjing First Hospital
RECRUITING
Najing
Jiangxi Provincial People's Hospital
RECRUITING
Nanchang
Jiangsu Province Hospital
NOT_YET_RECRUITING
Nanjing
Ruijin Hospital Shanghai Jiaotong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Shanghai General Hospital
RECRUITING
Shanghai
Shanghai Pulmonary Hospital
NOT_YET_RECRUITING
Shanghai
Taizhou Central Hospital
NOT_YET_RECRUITING
Taizhou
The First Affiliated Hospital of Xi'an Medical University
RECRUITING
Xi'an
The Affiliated Hospital of Xuzhou Medical College
RECRUITING
Xuzhou
Xuzhou Central Hospital
NOT_YET_RECRUITING
Xuzhou
Hungary
Koch Róbert Kórház és Rendelőintézet
RECRUITING
Edelény
Erzsebet Gondozohaz
RECRUITING
Gödöllő
Szalay János Rendelőintézet
RECRUITING
Hajdúnánás
Omnimodus Elixír Kft.
RECRUITING
Mosonmagyaróvár
Da Vinci Magánklinika
RECRUITING
Pécs
Italy
Policlinico Universitario Monserrato
RECRUITING
Monserrato
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
RECRUITING
Orbassano
IRCCS Istituto Clinico Humanitas
RECRUITING
Rozzano
Azienda Ospedaliero Universitaria Senese
RECRUITING
Siena
Azienda Ospedaliera Ordine Mauriziano di Torino
RECRUITING
Torino
Japan
Mazda Hospital
RECRUITING
Aki-gun Fuchu-cho
Fukuwa Clinic
RECRUITING
Chuo-ku
Fujieda Municipal General Hospital
NOT_YET_RECRUITING
Fujieda
Fukuoka National Hospital
RECRUITING
Fukuoka
Tokyo Medical University Hachioji Medical Center
RECRUITING
Hachiōji
Hamamatsu Rosai Hospital
RECRUITING
Hamamatsu
Hiroshima Prefectural Hospital
RECRUITING
Hiroshima
National Hospital Organization Osaka Minami Medical Center
RECRUITING
Kawachi-nagano
Kobe City Medical Center West Hospital
RECRUITING
Kobe
NHO Kinki Chuo Chest Medical Center
RECRUITING
Sakai
Poland
KLIMED Marek Klimkiewicz
RECRUITING
Bychawa
Małopolskie Centrum Alergologii
RECRUITING
Krakow
Alergologia Plus sp. z o.o.
RECRUITING
Poznan
Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o
RECRUITING
Poznan
PULMAG s.c.
RECRUITING
Sosnowiec
ALERGO-MED OŚRODEK BADAŃ KLINICZNYCH Sp. z o.o.
RECRUITING
Tarnów
Dobrostan Gabinet Lekarskie
RECRUITING
Wroclaw
Republic of Korea
Yeungnam Univeristy Medical Center
RECRUITING
Daegu
Yeungnam University hospital
RECRUITING
Daegu
Jeonbuk National University Hospital
RECRUITING
Jeonju
Asan Medical Center
RECRUITING
Seoul
Konkuk University Medical Center
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
The Catholic Univ. of Korea Seoul St. Mary's Hospital
RECRUITING
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
RECRUITING
Seoul
Spain
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
NOT_YET_RECRUITING
Málaga
Hospital Universitario Quironsalud Madrid
NOT_YET_RECRUITING
Pozuelo De Alarcón
Taiwan
Changhua Christian Hospital
NOT_YET_RECRUITING
Changhua County
Kaohsiung Medical University Chung-Ho Memorial Hospital
NOT_YET_RECRUITING
Kaohsiung City
Far Eastern Memorial Hospital
NOT_YET_RECRUITING
New Taipei City
Taichung Veterans General Hospital
NOT_YET_RECRUITING
Taichung
National Taiwan University Hospital
NOT_YET_RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
RECRUITING
Taoyuan District
United Kingdom
Bradford Royal Infirmary
NOT_YET_RECRUITING
Bradford
Addenbrooke's Hospital
RECRUITING
Cambridge
Outpatients
RECRUITING
Cambridge
North Manchester General Hospital
RECRUITING
Crumpsall
Hammersmith Hospital
NOT_YET_RECRUITING
London
Wythenshawe Hospital
RECRUITING
Manchester
Pinderfields General Hospital
RECRUITING
Wakefield
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-05-20
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 252
Treatments
Experimental: Treatment Arm A
PF-07275315
Experimental: Treatment Arm B
PF-07275315
Experimental: Treatment Arm C
PF-07275315
Placebo_comparator: Treatment Arm D
Placebo
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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