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 9.5 months. During this time, they will have 10 visits at the study clinic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
252
subcutaneous injection
subcutaneous injection
Velocity Clinical Research, Mobile
Mobile, Alabama, United States
NOT_YET_RECRUITINGAntelope Valley Clinical Trials
Lancaster, California, United States
RECRUITINGAllergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States
RECRUITINGAllergy & Asthma Clinical Research
Walnut Creek, California, United States
RECRUITINGCircuit Clinical / Impact Medical Allergy, Asthma & Immunology
Riverdale, New Jersey, United States
NOT_YET_RECRUITINGOK Clinical Research
Edmond, Oklahoma, United States
NOT_YET_RECRUITINGAllergy, Asthma and Clinical Research
Oklahoma City, Oklahoma, United States
RECRUITINGClinical Research of Rock Hill
Rock Hill, South Carolina, United States
NOT_YET_RECRUITINGPremier Research Center, LLC
Hendersonville, Tennessee, United States
NOT_YET_RECRUITINGAlina Clinical Trials, LLC.
Dallas, Texas, United States
NOT_YET_RECRUITING...and 6 more locations
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.
Time frame: Week 12
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
Time frame: Baseline through Week 32
Clinically significant, treatment-related laboratory abnormalities
Incidence of clinically significant changes in laboratory tests
Time frame: Baseline through Week 32
Clinically significant, treatment-related abnormalities in vital signs
Incidence of clinically significant changes in vital signs
Time frame: Baseline through Week 32
Clinically significant, treatment-related electrocardiogram (ECG) abnormalities
Incidence of clinically significant changes in ECG
Time frame: Baseline through Week 32
Change from baseline in pre-bronchodilator Percent (%) Predicted FEV1 at Week 12
Time frame: Week 12
Change from baseline in pre-bronchodilator FEV1 at all time points
Time frame: Baseline through Week 32
Change from baseline in pre-bronchodilator % Predicted FEV1 at all time points
Time frame: Baseline through Week 32
Change from baseline in pre-bronchodilator Forced Vital Capacity (FVC) at all time points
Time frame: Baseline through Week 32
Change from baseline in pre-bronchodilator % Predicted FVC at all time points
Time frame: Baseline through Week 32
Change from baseline in pre-bronchodilator FEV1/FVC Ratio at all time points
Time frame: Baseline through Week 32
Change from baseline in post-bronchodilator FEV1 at all time points
Time frame: Baseline through Week 32
Change from baseline in post-bronchodilator % Predicted FEV1 at all time points
Time frame: Baseline through Week 32
Change from baseline in post-bronchodilator FVC at all time points
Time frame: Baseline through Week 32
Change from baseline in post-bronchodilator % Predicted FVC at all time points
Time frame: Baseline through Week 32
Change from baseline in post-bronchodilator FEV1/FVC Ratio at all time points
Time frame: Baseline through Week 32
Change from baseline in FEV1 as a % of pre-bronchodilator result
Time frame: Baseline through Week 32
Change from baseline in pre-bronchodilator FEV1 at Week 12
Time frame: Week 12
Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) total score at Week 12
Time frame: Week 12
Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) global score at Week 12
Time frame: Week 12
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
Time frame: Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.