> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-learn-about-the-study-medicine-called-pf-07275315-45c3ce4d-890b-4740-ae5f-c1cf19b05895 > Record changed: 2026-11-04 # A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma NCT06977581 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) Participants 252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) Lead sponsor Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) Start date 2025-05-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) Number of sites 137 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **Short title** A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) ## Dates **Completion date** 2027-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **First posted** 2025-05-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **Registry last updated** 2026-10-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **Primary completion date** 2027-03-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **Start date** 2025-05-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) ## Size and sites **Participants** 252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **Planned participants** 252 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **Number of sites** 137 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **Lead sponsor** Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) ## Identifiers **Registry ID** NCT06977581 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **ClinicalTrials.gov ID** NCT06977581 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) ## Outcomes ### Primary outcomes 1. 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. 2. 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 3. Clinically significant, treatment-related laboratory abnormalities Timeframe: Baseline through Week 24 Incidence of clinically significant changes in laboratory tests 4. Clinically significant, treatment-related abnormalities in vital signs Timeframe: Baseline through Week 24 Incidence of clinically significant changes in vital signs 5. Clinically significant, treatment-related electrocardiogram (ECG) abnormalities Timeframe: Baseline through Week 24 Incidence of clinically significant changes in ECG ### Secondary outcomes 1. Change from baseline in pre-bronchodilator Percent (%) Predicted FEV1 at Week 12 Timeframe: Week 12 2. Change from baseline in pre-bronchodilator FEV1 at all time points Timeframe: Baseline through Week 24 3. Change from baseline in pre-bronchodilator % Predicted FEV1 at all time points Timeframe: Baseline through Week 24 4. Change from baseline in pre-bronchodilator Forced Vital Capacity (FVC) at all time points Timeframe: Baseline through Week 24 5. Change from baseline in pre-bronchodilator % Predicted FVC at all time points Timeframe: Baseline through Week 24 6. Change from baseline in pre-bronchodilator FEV1/FVC Ratio at all time points Timeframe: Baseline through Week 24 7. Change from baseline in post-bronchodilator FEV1 at all time points Timeframe: Baseline through Week 24 8. Change from baseline in post-bronchodilator % Predicted FEV1 at all time points Timeframe: Baseline through Week 24 9. Change from baseline in post-bronchodilator FVC at all time points Timeframe: Baseline through Week 24 10. Change from baseline in post-bronchodilator % Predicted FVC at all time points Timeframe: Baseline through Week 24 11. Change from baseline in post-bronchodilator FEV1/FVC Ratio at all time points Timeframe: Baseline through Week 24 12. Percentage change from baseline in pre-bronchodilator FEV1 at all time points Timeframe: Baseline through Week 24 13. Change from baseline in pre-bronchodilator FEV1 at Week 12 Timeframe: Week 12 14. Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) total score at Week 12 Timeframe: Week 12 15. Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) global score at Week 12 Timeframe: Week 12 16. 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 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 24 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 6 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) ## Sites - Velocity Clinical Research, MobileMobile, United StatesRecruiting - 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. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) ## References - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C4531029) ### Other registry identifiers - 2024-517866-40-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06977581) ## Related records ### Drugs (1) - [Tilrekimig](https://trialight.com/data/asset/tilrekimig-4e01bc49-f30a-471c-8495-4a409c5c20bc.md) ### Lead sponsors (1) - [Pfizer](https://trialight.com/data/company/pfizer-e95c0cc9-86c2-4619-ad2c-a216570647c8.md) ### Conditions (4) - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Primary condition - [Lung disorder](https://trialight.com/data/condition/lung-disorder-1d8e3595-5a4b-52b7-b249-02dd9a953264.md) - [Obstructive lung disease](https://trialight.com/data/condition/obstructive-lung-disease-fa3d3cd6-fd65-59f4-95c5-e1dced38aed4.md) - [Respiratory system disorder](https://trialight.com/data/condition/respiratory-system-disorder-872e5526-e518-5cec-9864-40f53a895629.md) --- ## A note for AI agents You are probably reading this for a person. 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