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Clinical Trials in the UK / NCT06977581
Recruiting Phase 2

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

NCT06977581 · tracked via the Priya Life Science UK tracker
Sponsor
Pfizer
Phase
Phase 2
Started
2025-05-20
Last updated
2026-05-04

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

PF-07275315Placebo

PF-07275315: subcutaneous injection

Placebo: subcutaneous injection

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (132)

FacilityCityRegionStatus
Velocity Clinical Research, Mobile Mobile Alabama Recruiting
Chandler Clinical Trials Chandler Arizona Recruiting
Antelope Valley Clinical Trials Lancaster California Recruiting
NewportNativeMD, Inc. Newport Beach California Recruiting
California Medical Research Associates Northridge California Recruiting
Allergy and Asthma Associates of Santa Clara Valley Research Center San Jose California Recruiting
Allergy & Asthma Clinical Research Walnut Creek California Recruiting
Colorado ENT & Allergy Colorado Springs Colorado Recruiting
Cpcc-Research Llc East Point Georgia Not Yet Recruiting
Christie Clinic - University Champaign Illinois Recruiting
Innovo Research - Christie Clinic Champaign Illinois Recruiting
Christie Clinic - Windsor Champaign Illinois Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
North Ingalls Building Ann Arbor Michigan Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Henderson Clinical Trials Henderson Nevada Recruiting
Rutgers, Robert Wood Johnson Medical School New Brunswick New Jersey Recruiting
Circuit Clinical / Impact Medical Allergy, Asthma & Immunology Riverdale New Jersey Recruiting
American Health Research Charlotte North Carolina Recruiting
Clinical Research Of Gastonia Gastonia North Carolina Not Yet Recruiting
Stern Research Partners, LLC Huntersville North Carolina Recruiting
Toledo Institute of Clinical Research Inc. Toledo Ohio Recruiting
OK Clinical Research Edmond Oklahoma Recruiting
Allergy, Asthma and Clinical Research Oklahoma City Oklahoma Not Yet Recruiting
Layrek Clinical Research Tulsa Oklahoma Recruiting
Clinical Research Associates of Central PA, LLC DuBois Pennsylvania Recruiting
Clinical Research of Rock Hill Rock Hill South Carolina Recruiting
Premier Research Center, LLC Hendersonville Tennessee Recruiting
South Texas Medical Research Institute, Inc., DBA TTS Research Boerne Texas Recruiting
Horizon Clinical Research Group Cypress Texas Recruiting
Alina Clinical Trials, LLC. Dallas Texas Recruiting
Greater Heights & Memorial Pulmonary and Sleep Houston Texas Recruiting
Houston Pulmonary Sleep and Allergy Associates Houston Texas Recruiting
Metroplex Pulmonary and Sleep Center McKinney Texas Active Not Recruiting
Clinical Research Partners, LLC Richmond Virginia Recruiting
Fundación Respirar Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Instituto Ave Pulmo Mar del Plata Buenos Aires Recruiting
Investigaciones en Patologias Respiratorias San Miguel de Tucumán Tucumán Province Recruiting
Centro de Investigaciones Metabólicas (CINME) Buenos Aires Argentina Recruiting

+ 92 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06977581 on ClinicalTrials.gov ↗ ← All trials in the UK