Clinical trial NCT06977581: A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Dose-Ranging Study to Investigate the Efficacy and Safety of PF-07275315 in Adult Participants With Inadequately Controlled Moderate-to-Severe Asthma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Asthma
Keywords: Pulmonary
Wheezing
Respiratory hypersensitivity
Airway Inflammation
Airway Obstruction
Dyspnea
Lung Diseases
Respiratory Tract Diseases
Asthma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2025-05-18
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 9.5 months. During this time, they will have 10 visits at the study clinic.


Eligibility criteria: 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. Pre-bronchodilator FEV1 of ≥30% to \<80% of predicted normal values during screening period.
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-4Rα, TSLP, IL-5, 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 or injectable) corticosteroids within 28 days of the screening visit through the end of study (except to treat an acute exacerbation).
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 outcomes:
measure: Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12
timeFrame: Week 12
measure: Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs/SAEs leading to treatment discontinuation
timeFrame: Baseline through Week 32
measure: Clinically significant, treatment-related laboratory abnormalities
timeFrame: Baseline through Week 32
measure: Clinically significant, treatment-related abnormalities in vital signs
timeFrame: Baseline through Week 32
measure: Clinically significant, treatment-related electrocardiogram (ECG) abnormalities
timeFrame: Baseline through Week 32
Secondary outcomes:
measure: Change from baseline in pre-bronchodilator Percent (%) Predicted FEV1 at Week 12
timeFrame: Week 12
measure: Change from baseline in pre-bronchodilator FEV1 at all time points
timeFrame: Baseline through Week 32
measure: Change from baseline in pre-bronchodilator % Predicted FEV1 at all time points
timeFrame: Baseline through Week 32
measure: Change from baseline in pre-bronchodilator Forced Vital Capacity (FVC) at all time points
timeFrame: Baseline through Week 32
measure: Change from baseline in pre-bronchodilator % Predicted FVC at all time points
timeFrame: Baseline through Week 32
measure: Change from baseline in pre-bronchodilator FEV1/FVC Ratio at all time points
timeFrame: Baseline through Week 32
measure: Change from baseline in post-bronchodilator FEV1 at all time points
timeFrame: Baseline through Week 32
measure: Change from baseline in post-bronchodilator % Predicted FEV1 at all time points
timeFrame: Baseline through Week 32
measure: Change from baseline in post-bronchodilator FVC at all time points
timeFrame: Baseline through Week 32
measure: Change from baseline in post-bronchodilator % Predicted FVC at all time points
timeFrame: Baseline through Week 32
measure: Change from baseline in post-bronchodilator FEV1/FVC Ratio at all time points
timeFrame: Baseline through Week 32
measure: Change from baseline in FEV1 as a % of pre-bronchodilator result
timeFrame: Baseline through Week 32
measure: Change from baseline in pre-bronchodilator FEV1 at Week 12
timeFrame: Week 12
measure: Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) total score at Week 12
timeFrame: Week 12
measure: Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) global score at Week 12
timeFrame: Week 12
measure: 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
timeFrame: Week 12
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Velocity Clinical Research, Mobile
state: Alabama
city: Lancaster
country: United States
facility: Antelope Valley Clinical Trials
state: California
city: San Jose
country: United States
facility: Allergy and Asthma Associates of Santa Clara Valley Research Center
state: California
city: Walnut Creek
country: United States
facility: Allergy & Asthma Clinical Research
state: California
city: Riverdale
country: United States
facility: Circuit Clinical / Impact Medical Allergy, Asthma & Immunology
state: New Jersey
city: Edmond
country: United States
facility: OK Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Allergy, Asthma and Clinical Research
state: Oklahoma
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
city: Hendersonville
country: United States
facility: Premier Research Center, LLC
state: Tennessee
city: Dallas
country: United States
facility: Alina Clinical Trials, LLC.
state: Texas
city: Houston
country: United States
facility: Greater Heights & Memorial Pulmonary and Sleep
state: Texas
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Kawachinagano
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center
state: Osaka
city: Sakai
country: Japan
facility: NHO Kinki Chuo Chest Medical Center
state: Osaka
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: