Recruiting
Phase 2

PF-07275315

Sponsor:

Pfizer

Code:

NCT06977581

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

PF-07275315

Placebo

Study Details

Brief 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.

Conditions

Asthma

Study ID

NCT06977581

Start date

May 20, 2025

Status verified date

Apr, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Mar 8, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

252 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm A

PF-07275315

experimental: Treatment Arm B

PF-07275315

experimental: Treatment Arm C

PF-07275315

placebo comparator: Treatment Arm D

Placebo

Interventions

PF-07275315

subcutaneous injection

Placebo

subcutaneous injection

Primary outcome measure

  • Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12 [ Time Frame: Week 12 ]
  • Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs/SAEs leading to treatment discontinuation [ Time Frame: Baseline through Week 24 ]
  • Clinically significant, treatment-related laboratory abnormalities [ Time Frame: Baseline through Week 24 ]
  • Clinically significant, treatment-related abnormalities in vital signs [ Time Frame: Baseline through Week 24 ]
  • Clinically significant, treatment-related electrocardiogram (ECG) abnormalities [ Time Frame: Baseline through Week 24 ]

Central Contacts and Locations

Central contacts

Locations

Velocity Clinical Research, Mobile

Recruiting

Mobile, Alabama, United States, 36608

Chandler Clinical Trials

Recruiting

Chandler, Arizona, United States, 85224

Antelope Valley Clinical Trials

Recruiting

Lancaster, California, United States, 93534

NewportNativeMD, Inc.

Recruiting

Newport Beach, California, United States, 92663

California Medical Research Associates

Recruiting

Northridge, California, United States, 91324

Allergy and Asthma Associates of Santa Clara Valley Research Center

Recruiting

San Jose, California, United States, 95117

Allergy & Asthma Clinical Research

Recruiting

Walnut Creek, California, United States, 94598

Colorado ENT & Allergy

Recruiting

Colorado Springs, Colorado, United States, 80923

Christie Clinic - University

Recruiting

Champaign, Illinois, United States, 61820

Innovo Research - Christie Clinic

Recruiting

Champaign, Illinois, United States, 61820

Christie Clinic - Windsor

Recruiting

Champaign, Illinois, United States, 61822

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

North Ingalls Building

Recruiting

Ann Arbor, Michigan, United States, 48109

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Henderson Clinical Trials

Recruiting

Henderson, Nevada, United States, 89052

Rutgers, Robert Wood Johnson Medical School

Recruiting

New Brunswick, New Jersey, United States, 08901

Circuit Clinical / Impact Medical Allergy, Asthma & Immunology

Recruiting

Riverdale, New Jersey, United States, 07457

American Health Research

Recruiting

Charlotte, North Carolina, United States, 28277

Stern Research Partners, LLC

Recruiting

Huntersville, North Carolina, United States, 28078

Toledo Institute of Clinical Research Inc.

Recruiting

Toledo, Ohio, United States, 43617

OK Clinical Research

Recruiting

Edmond, Oklahoma, United States, 73034

Layrek Clinical Research

Recruiting

Tulsa, Oklahoma, United States, 74133

Clinical Research Associates of Central PA, LLC

Recruiting

DuBois, Pennsylvania, United States, 15801

Clinical Research of Rock Hill

Recruiting

Rock Hill, South Carolina, United States, 29732

Premier Research Center, LLC

Recruiting

Hendersonville, Tennessee, United States, 37075

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

Recruiting

Boerne, Texas, United States, 78006

Horizon Clinical Research Group

Recruiting

Cypress, Texas, United States, 77429

Alina Clinical Trials, LLC.

Recruiting

Dallas, Texas, United States, 75209

Greater Heights & Memorial Pulmonary and Sleep

Recruiting

Houston, Texas, United States, 77008

Houston Pulmonary Sleep and Allergy Associates

Recruiting

Houston, Texas, United States, 77065

Clinical Research Partners, LLC

Recruiting

Richmond, Virginia, United States, 23226

More Information

Sponsor

Pfizer

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • Pulmonary
  • Wheezing
  • Respiratory hypersensitivity
  • Airway Inflammation
  • Airway Obstruction
  • Dyspnea
  • Lung Diseases
  • Respiratory Tract Diseases
  • Asthma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-05-04.