A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
- 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 75 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 6 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 up to approximately 9.5 months depending on local requirements.
- Short title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2027-05-31
- First posted
- 2025-05-18
- Registry last updated
- 2026-10-13
- Primary completion date
- 2027-03-08
- Start date
- 2025-05-20
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Pfizer
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06977581
- ClinicalTrials.gov ID
- NCT06977581
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Timeframe: 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
Timeframe: 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
Timeframe: Baseline through Week 24
Incidence of clinically significant changes in laboratory tests
Clinically significant, treatment-related abnormalities in vital signs
Timeframe: Baseline through Week 24
Incidence of clinically significant changes in vital signs
Clinically significant, treatment-related electrocardiogram (ECG) abnormalities
Timeframe: Baseline through Week 24
Incidence of clinically significant changes in ECG
Change from baseline in pre-bronchodilator Percent (%) Predicted FEV1 at Week 12
Timeframe: Week 12
Change from baseline in pre-bronchodilator FEV1 at all time points
Timeframe: Baseline through Week 24
Change from baseline in pre-bronchodilator % Predicted FEV1 at all time points
Timeframe: Baseline through Week 24
Change from baseline in pre-bronchodilator Forced Vital Capacity (FVC) at all time points
Timeframe: Baseline through Week 24
Change from baseline in pre-bronchodilator % Predicted FVC at all time points
Timeframe: Baseline through Week 24
Change from baseline in pre-bronchodilator FEV1/FVC Ratio at all time points
Timeframe: Baseline through Week 24
Change from baseline in post-bronchodilator FEV1 at all time points
Timeframe: Baseline through Week 24
Change from baseline in post-bronchodilator % Predicted FEV1 at all time points
Timeframe: Baseline through Week 24
Change from baseline in post-bronchodilator FVC at all time points
Timeframe: Baseline through Week 24
Change from baseline in post-bronchodilator % Predicted FVC at all time points
Timeframe: Baseline through Week 24
Change from baseline in post-bronchodilator FEV1/FVC Ratio at all time points
Timeframe: Baseline through Week 24
Percentage change from baseline in pre-bronchodilator FEV1 at all time points
Timeframe: Baseline through Week 24
Change from baseline in pre-bronchodilator FEV1 at Week 12
Timeframe: Week 12
Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) total score at Week 12
Timeframe: Week 12
Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) global score at Week 12
Timeframe: 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
Timeframe: Week 12
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
Must meet the following asthma criteria:
-
History of persistent, moderate-to-severe asthma for at least 12 months prior to screening.
-
Must have experienced at least 1 asthma exacerbation requiring treatment with systemic steroids (oral or parenteral) for 3 days or more within 24 months of the screening visit.
-
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.
-
Positive bronchodilator responsiveness as evidenced by increase in FEV1 of at least 12% and 200 mL for spirometry conducted during screening period.
-
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 6 months prior to the screening visit and at a stable dose for at least 3 months prior to the screening visit.
-
ACQ-5 score of ≥1.5 at screening visit and prior to randomization.
Other Inclusion Criteria:
-
Body mass index between 18 -40 kg/m2 at screening.
Medical Conditions:
-
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.
-
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
-
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:
-
Prior or current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
-
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.
-
Treatment with any dose level of systemic (oral, injectable, or intraarticular) corticosteroids within 28 days of the screening visit.
-
Prior (within 12 weeks prior to screening) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig).
-
History of anaphylaxis to antibody therapeutic or to PF-07275315 or to the excipients of the formulated drug products.
-
Bronchial thermoplasty within the previous 24 months.
Prior/Concurrent Clinical Study Experience:
-
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.
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- Chandler Clinical TrialsChandler, United StatesRecruiting
- Antelope Valley Clinical TrialsLancaster, United StatesRecruiting
- NewportNativeMD, Inc.Newport Beach, United StatesRecruiting
- California Medical Research AssociatesNorthridge, United StatesRecruiting
- Allergy and Asthma Associates of Santa Clara Valley Research CenterSan Jose, United StatesRecruiting
- Allergy & Asthma Clinical ResearchWalnut Creek, United StatesRecruiting
- Colorado ENT & AllergyColorado Springs, United StatesRecruiting
- Cpcc-Research LlcEast Point, United StatesRecruiting
- Christie Clinic - UniversityChampaign, United StatesRecruiting
- Innovo Research - Christie ClinicChampaign, United StatesRecruiting
- Christie Clinic - WindsorChampaign, United StatesRecruiting
- University of Kansas Medical CenterKansas City, United StatesRecruiting
- North Ingalls BuildingAnn Arbor, United StatesRecruiting
- University of MichiganAnn Arbor, United StatesRecruiting
- Washington University School of MedicineSt Louis, United StatesRecruiting
- Henderson Clinical TrialsHenderson, United StatesRecruiting
- Rutgers, Robert Wood Johnson Medical SchoolNew Brunswick, United StatesRecruiting
- Circuit Clinical / Impact Medical Allergy, Asthma & ImmunologyRiverdale, United StatesRecruiting
- American Health ResearchCharlotte, United StatesRecruiting
- Clinical Research Of GastoniaGastonia, United StatesRecruiting
- Stern Research Partners, LLCHuntersville, United StatesRecruiting
- Toledo Institute of Clinical Research Inc.Toledo, United StatesRecruiting
- OK Clinical ResearchEdmond, United StatesRecruiting
- Allergy, Asthma and Clinical ResearchOklahoma City, United StatesRecruiting
And 112 more, listed on the interactive page.
- Related resource (pmiform.com)
Other registry identifiers
- 2024-517866-40-00
Related records
Drugs (1)
Lead sponsors (1)
Conditions (4)
- Asthma Primary condition
- Lung disorder
- Obstructive lung disease
- Respiratory system disorder