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AsthmaPhase 2NCT06977581

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

A Phase 2 study testing PF-07275315 in people with Asthma, run by Pfizer at 137 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthma
What is being tested?
PF-07275315
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
252 participants
Where
137 sitesin 15 countries
Study dates
20 May 2025to 31 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 24 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 6 months prior to the screening visit and at a stable dose for at least 3 months prior to the screening visit.
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  • 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.

Who cannot join

  • 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;
Show all 16Show fewer
  • 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:
  • 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.

Trial locations and contacts

137 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

137 sites in 15 countries

United States36 sites, 35 recruiting

  • North Ingalls Building

    Ann Arbor, Michigan, 48109

    Recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Recruiting

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

    Boerne, Texas, 78006

    Recruiting

  • Christie Clinic - University

    Champaign, Illinois, 61820

    Recruiting

  • Innovo Research - Christie Clinic

    Champaign, Illinois, 61820

    Recruiting

  • Christie Clinic - Windsor

    Champaign, Illinois, 61822

    Recruiting

  • Chandler Clinical Trials

    Chandler, Arizona, 85224

    Recruiting

  • American Health Research

    Charlotte, North Carolina, 28277

    Recruiting

  • Colorado ENT & Allergy

    Colorado Springs, Colorado, 80923

    Recruiting

  • Horizon Clinical Research Group

    Cypress, Texas, 77429

    Recruiting

  • Alina Clinical Trials, LLC.

    Dallas, Texas, 75209

    Recruiting

  • Clinical Research Associates of Central PA, LLC

    DuBois, Pennsylvania, 15801

    Recruiting

  • Cpcc-Research Llc

    East Point, Georgia, 30344

    Recruiting

  • OK Clinical Research

    Edmond, Oklahoma, 73034

    Recruiting

  • Clinical Research Of Gastonia

    Gastonia, North Carolina, 28054

    Recruiting

  • Henderson Clinical Trials

    Henderson, Nevada, 89052

    Recruiting

  • Premier Research Center, LLC

    Hendersonville, Tennessee, 37075

    Recruiting

  • Greater Heights & Memorial Pulmonary and Sleep

    Houston, Texas, 77008

    Recruiting

  • Houston Pulmonary Sleep and Allergy Associates

    Houston, Texas, 77065

    Recruiting

  • Stern Research Partners, LLC

    Huntersville, North Carolina, 28078

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Recruiting

  • Antelope Valley Clinical Trials

    Lancaster, California, 93534

    Recruiting

  • Metroplex Pulmonary and Sleep Center

    McKinney, Texas, 75069

    Active, not recruiting

  • Velocity Clinical Research, Mobile

    Mobile, Alabama, 36608

    Recruiting

  • Rutgers, Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

    Recruiting

  • NewportNativeMD, Inc.

    Newport Beach, California, 92663

    Recruiting

  • California Medical Research Associates

    Northridge, California, 91324

    Recruiting

  • Allergy, Asthma and Clinical Research

    Oklahoma City, Oklahoma, 73120

    Recruiting

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226

    Recruiting

  • Circuit Clinical / Impact Medical Allergy, Asthma & Immunology

    Riverdale, New Jersey, 07457

    Recruiting

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732

    Recruiting

  • Allergy and Asthma Associates of Santa Clara Valley Research Center

    San Jose, California, 95117

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Recruiting

  • Toledo Institute of Clinical Research Inc.

    Toledo, Ohio, 43617

    Recruiting

  • Layrek Clinical Research

    Tulsa, Oklahoma, 74133

    Recruiting

  • Allergy & Asthma Clinical Research

    Walnut Creek, California, 94598

    Recruiting

Other trials in United States

China20 sites, 20 recruiting

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia, 014010

    Recruiting

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100020

    Recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

    Recruiting

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130000

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Recruiting

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510150

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

    Recruiting

  • The First People's Hospital of Hangzhou

    Hangzhou, Zhejiang

    Recruiting

  • Inner Mongolia People's Hospital

    Hohhot, Inner Mongolia, 010017

    Recruiting

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010050

    Recruiting

  • Nanjing First Hospital

    Najing, Jiangsu, 210001

    Recruiting

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

    Recruiting

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

    Recruiting

  • Taizhou Central Hospital

    Taizhou, Zhejiang, 318000

    Recruiting

  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, Shaanxi, 710077

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu, 221006

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

    Recruiting

Other trials in China

Japan10 sites, 10 recruiting

  • Mazda Hospital

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

    Recruiting

  • Fukuwa Clinic

    Chuo-ku, Tokyo, 104-0031

    Recruiting

  • Fujieda Municipal General Hospital

    Fujieda, Shizuoka, 426-8677

    Recruiting

  • Fukuoka National Hospital

    Fukuoka, 811-1394

    Recruiting

  • Tokyo Medical University Hachioji Medical Center

    Hachiōji, Tokyo, 1930998

    Recruiting

  • Hamamatsu Rosai Hospital

    Hamamatsu, Shizuoka, 430-8525

    Recruiting

  • Hiroshima Prefectural Hospital

    Hiroshima, 734-0004

    Recruiting

  • National Hospital Organization Osaka Minami Medical Center

    Kawachi-Nagano, Osaka, 586-8521

    Recruiting

  • Kobe City Medical Center West Hospital

    Kobe, Hyōgo, 653-0013

    Recruiting

  • NHO Kinki Chuo Chest Medical Center

    Sakai, Osaka, 591-8555

    Recruiting

Other trials in Japan

South Korea10 sites, 9 recruiting

  • Yeungnam University hospital

    Daegu, Kyǒngsangbuk-do, 42415

    Recruiting

  • Yeungnam Univeristy Medical Center

    Daegu, Taegu-kwangyǒkshi, 42415

    Recruiting

  • Jeonbuk National University Hospital

    Jeonju, Jeonrabugdo, 54907

    Recruiting

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

    Seoul, Seoul-teukbyeolsi [seoul], 03312

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul], 03722

    Recruiting

  • Konkuk University Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 05030

    Recruiting

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 05505

    Recruiting

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 06351

    Recruiting

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

    Seoul, Seoul-teukbyeolsi [seoul], 06591

    Terminated

  • Korea University Guro Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 08308

    Recruiting

Other trials in South Korea

Argentina8 sites, 8 recruiting

  • Fundacion Cidea

    Buenos Aires, Buenos Aires F.D., C1121ABE

    Recruiting

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI

    Recruiting

  • Fundación Respirar

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP

    Recruiting

  • Instituto Ave Pulmo

    Mar del Plata, Buenos Aires, 7600

    Recruiting

  • Fundacion Scherbovsky

    Mendoza, 5500

    Recruiting

  • Instituto de Salud Respiratoria

    Mendoza, 5500

    Recruiting

  • Instituto Especialidades de la Salud Rosario

    Rosario, Santa Fe Province, S2000 DBS

    Recruiting

  • Investigaciones en Patologias Respiratorias

    San Miguel de Tucumán, Tucumán Province, 4000

    Recruiting

Other trials in Argentina

Italy7 sites, 7 recruiting

  • Policlinico Universitario Monserrato

    Monserrato, Cagliari, 09042

    Recruiting

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, Piedmont, 10043

    Recruiting

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

    Reggio Emilia, Emilia-Romagna, 42123

    Recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano, Milano, 20089

    Recruiting

  • Azienda Ospedaliero OO.RR. S. Giovanni di Dio e Ruggi D' Aragona

    Salerno, 84131

    Recruiting

  • Azienda Ospedaliero Universitaria Senese

    Siena, Tuscany, 53100

    Recruiting

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, 10128

    Recruiting

Other trials in Italy

Poland7 sites, 7 recruiting

  • KLIMED Marek Klimkiewicz

    Bychawa, Lublin Voivodeship, 23-100

    Recruiting

  • Małopolskie Centrum Alergologii

    Krakow, Lesser Poland Voivodeship, 31-624

    Recruiting

  • Alergologia Plus sp. z o.o.

    Poznan, Greater Poland Voivodeship, 60-693

    Recruiting

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

    Poznan, Greater Poland Voivodeship, 61-578

    Recruiting

  • PULMAG s.c.

    Sosnowiec, Silesian Voivodeship, 41-208

    Recruiting

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

    Tarnów, Lesser Poland Voivodeship, 33-100

    Recruiting

  • Dobrostan Gabinet Lekarskie

    Wroclaw, Lower Silesian Voivodeship, 53-301

    Recruiting

Other trials in Poland

United Kingdom7 sites, 7 recruiting

  • Bradford Royal Infirmary

    Bradford, BD9 6RJ

    Recruiting

  • Outpatients

    Cambridge, Cambridgeshire, cb2 0qq

    Recruiting

  • Addenbrooke's Hospital

    Cambridge, Cambridgeshire, CB2 2QQ

    Recruiting

  • North Manchester General Hospital

    Crumpsall, M8 5RB

    Recruiting

  • Hammersmith Hospital

    London, London, CITY of, W12 0HS

    Recruiting

  • Wythenshawe Hospital

    Manchester, Greater Manchester, M23 9LT

    Recruiting

  • Pinderfields General Hospital

    Wakefield, WF1 4DG

    Recruiting

Other trials in United Kingdom

Taiwan6 sites, 6 recruiting

  • Changhua Christian Hospital

    Changhua County, Changhua, 50006

    Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

    Recruiting

  • Far Eastern Memorial Hospital

    New Taipei City, NEW Taipei, 220

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407

    Recruiting

  • National Taiwan University Hospital

    Taipei, 10002

    Recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

Hungary5 sites, 5 recruiting

  • Koch Róbert Kórház és Rendelőintézet

    Edelény, Borsod-Abauj Zemplen county, 3780

    Recruiting

  • Erzsebet Gondozohaz

    Gödöllő, Pest County, 2100

    Recruiting

  • Szalay János Rendelőintézet

    Hajdúnánás, Hajdú-Bihar, 4080

    Recruiting

  • Omnimodus Elixír Kft.

    Mosonmagyaróvár, Győr-Moson-Sopron, 9200

    Recruiting

  • Da Vinci Magánklinika

    Pécs, 7635

    Recruiting

Other trials in Hungary

South Africa5 sites, 5 recruiting

  • St. Augustine's Medical Centre 2

    Durban, KwaZulu-Natal, 4001

    Recruiting

  • Synapta Clinical Research Centre

    Durban, KwaZulu-Natal, 4001

    Recruiting

  • Durban International Clinical Research Site, Enhancing Care Foundation

    Durban, KwaZulu-Natal, 4301

    Recruiting

  • WITS Clinical Research

    Johannesberg, Gauteng, 2193

    Recruiting

  • WITS Clinical Research

    Johannesburg, Gauteng, 2193

    Recruiting

Other trials in South Africa

Spain5 sites, 4 recruiting

  • Hospital Universitario La Paz

    Madrid, Madrid, Comunidad de, 28046

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga, 29010

    Recruiting

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223

    Active, not recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

    Recruiting

Other trials in Spain

Bulgaria4 sites, 4 recruiting

  • Medical Center Pulmo - 2018 EOOD

    Haskovo, 6300

    Recruiting

  • Diagnostic Consultative Center Aleksandrovska

    Sofia, Sofia (stolitsa), 1431

    Recruiting

  • Medical Center Pulmovision

    Sofia, 1756

    Recruiting

  • Medical Center New Rehabilitation Center EOOD

    Stara Zagora, 6001

    Recruiting

Other trials in Bulgaria

Czechia4 sites, 4 recruiting

  • Mudr.I.Cierna Peterova s.r.o.

    Brandýs nad Labem, Central Bohemia, 25001

    Recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

    Recruiting

  • MEDITRIAL s.r.o.

    Jindrichuv Hradec III, South Bohemian Region, 377 01

    Recruiting

  • CEFISPIRO s.r.o.

    Lovosice, 410 02

    Recruiting

Other trials in Czechia

Belgium3 sites, 3 recruiting

  • UZ Gent

    Ghent, Oost-vlaanderen, 9000

    Recruiting

  • Centre Hospitalier Régional de la Citadelle

    Liège, 4000

    Recruiting

  • AZ Sint-Maarten

    Mechelen, Antwerpen, 2800

    Recruiting

Other trials in Belgium

About this study

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

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:

Read more
  • Are 18 to 75 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 6 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 up to approximately 9.5 months depending on local requirements.

Conditions
Asthma
Being tested
PF-07275315, Placebo
Keywords
Pulmonary, Wheezing, Respiratory hypersensitivity, Airway Inflammation, Airway Obstruction, Dyspnea, Lung Diseases, Respiratory Tract Diseases, Asthma
Medical subject headings
Asthma, Respiratory Sounds, Respiratory Hypersensitivity, Airway Obstruction, Dyspnea, Lung Diseases, Respiratory Tract Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-07275315Drug

    subcutaneous injection

  • PlaceboOther

    subcutaneous injection

Study groups in NCT06977581
Study groupRoleWhat they receive
Treatment Arm AExperimentalPF-07275315
Receives: Drug: PF-07275315
Treatment Arm BExperimentalPF-07275315
Receives: Drug: PF-07275315
Treatment Arm CExperimentalPF-07275315
Receives: Drug: PF-07275315
Treatment Arm DPlacebo comparatorPlacebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 12

  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

    Measured: Baseline through Week 24

  3. Clinically significant, treatment-related laboratory abnormalities

    Incidence of clinically significant changes in laboratory tests

    Measured: Baseline through Week 24

  4. Clinically significant, treatment-related abnormalities in vital signs

    Incidence of clinically significant changes in vital signs

    Measured: Baseline through Week 24

  5. Clinically significant, treatment-related electrocardiogram (ECG) abnormalities

    Incidence of clinically significant changes in ECG

    Measured: Baseline through Week 24

Secondary outcomes (16)

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

    Measured: Week 12

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

    Measured: Baseline through Week 24

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

    Measured: Baseline through Week 24

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

    Measured: Baseline through Week 24

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

    Measured: Baseline through Week 24

  6. Change from baseline in pre-bronchodilator FEV1/FVC Ratio at all time points

    Measured: Baseline through Week 24

  7. Change from baseline in post-bronchodilator FEV1 at all time points

    Measured: Baseline through Week 24

  8. Change from baseline in post-bronchodilator % Predicted FEV1 at all time points

    Measured: Baseline through Week 24

  9. Change from baseline in post-bronchodilator FVC at all time points

    Measured: Baseline through Week 24

  10. Change from baseline in post-bronchodilator % Predicted FVC at all time points

    Measured: Baseline through Week 24

  11. Change from baseline in post-bronchodilator FEV1/FVC Ratio at all time points

    Measured: Baseline through Week 24

  12. Percentage change from baseline in pre-bronchodilator FEV1 at all time points

    Measured: Baseline through Week 24

  13. Change from baseline in pre-bronchodilator FEV1 at Week 12

    Measured: Week 12

  14. Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) total score at Week 12

    Measured: Week 12

  15. Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) global score at Week 12

    Measured: 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

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2025
  2. Study start20 May 2025
  3. Primary completion8 Mar 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
252 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06977581
Sponsor's protocol ID
C4531029
Other IDs
2024-517866-40-00
Status last verified
Oct 2026
First submitted
25 Apr 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-07275315 in people with Asthma, run by Pfizer at 137 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 137 sites in United States, China, Japan, South Korea, Argentina and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (time frame: Week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06977581.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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Clinical Trial NCT06977581 | AzTrials