RecruitingAsthma

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

Eligible age

18–70 yrs

Accepts

All genders

Locations

19 states

Healthy volunteers

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About this study

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.

Sponsor: Pfizer

You may qualify if…

✓ 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:

You may not qualify if…

✕ 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: