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)
Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12 — 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 — 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 — Baseline through Week 24 Incidence of clinically significant changes in laboratory tests
Clinically significant, treatment-related abnormalities in vital signs — Baseline through Week 24 Incidence of clinically significant changes in vital signs
Clinically significant, treatment-related electrocardiogram (ECG) abnormalities — Baseline through Week 24 Incidence of clinically significant changes in ECG
Trial sites (137)
Facility
City
Region
Status
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
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
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
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
Fundacion Cidea
Buenos Aires
Buenos Aires F.D.
Recruiting
Instituto Especialidades de la Salud Rosario
Rosario
Santa Fe Province
Recruiting
+ 97 more sites — see the full list on the official registry below.
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.
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