NCT06977581 · Pfizer
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
PF-07275315
subcutaneous injection
OTHER
Placebo
subcutaneous injection
Primary outcome measures
Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Time frame: 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.
Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs/SAEs leading to treatment discontinuation
Time frame: Baseline through Week 24
Incidence of treatment-emergent AEs, treatment-emergent SAEs, and treatment-emergent AEs/SAEs leading to treatment discontinuation
Clinically significant, treatment-related laboratory abnormalities
Time frame: Baseline through Week 24
Incidence of clinically significant changes in laboratory tests
Clinically significant, treatment-related abnormalities in vital signs
Time frame: Baseline through Week 24
Incidence of clinically significant changes in vital signs
Clinically significant, treatment-related electrocardiogram (ECG) abnormalities
Time frame: Baseline through Week 24
Incidence of clinically significant changes in ECG
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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:
- 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.
Where
- Mobile, Alabama
- Chandler, Arizona
- Lancaster, California
- Newport Beach, California
- Northridge, California
- San Jose, California
- Walnut Creek, California
- Colorado Springs, Colorado
- East Point, Georgia
- Champaign, Illinois
- Kansas City, Kansas
- Ann Arbor, Michigan
And 20 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 13, 2026 · Source of record for eligibility and locations