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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

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

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Recruiting

Aug. 07, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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 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:
7.Body mass index between 18~40 kg/m2 at screening.

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-4R alpha, 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.

Both

Asthma

Treatment Arm A: PF-07275315, Treatment Arm B: PF-07275315, Treatment Arm C: PF-07275315, Treatment Arm D: Placebo (subcutaneous injection in all arms)

* Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (FEV1: the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, obtained from spirometry)
* Incidence of Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs/SAEs leading to treatment discontinuation (Time Frame: Baseline through Week 24)
*Incidence of clinically significant, treatment-related laboratory abnormalities (Baseline through Week 24)
* Incidence of clinically significant, treatment-related abnormalities in vital signs (Baseline through Week 24)
* Incidence of clinically significant, treatment-related electrocardiogram (ECG) abnormalities (Baseline through Week 24)

*Change from baseline in pre-bronchodilator Percent (%) Predicted FEV1 at Week 12
*Change from baseline in pre-bronchodilator FEV1 at all time points through Week 24
*Change from baseline in pre-bronchodilator % Predicted FEV1 at all time points through Week 24
*Change from baseline in pre-bronchodilator Forced Vital Capacity (FVC) at all time points through Week 24
*Change from baseline in pre-bronchodilator % Predicted FVC at all time points through Week 24
*Change from baseline in pre-bronchodilator FEV1/FVC Ratio at all time points through Week 24
*Change from baseline in post-bronchodilator FEV1 at all time points through Week 24
*Change from baseline in post-bronchodilator % Predicted FEV1 at all time points through Week 24
*Change from baseline in post-bronchodilator FVC at all time points through Week 24
*Change from baseline in post-bronchodilator % Predicted FVC at all time points through Week 24
*Change from baseline in post-bronchodilator FEV1/FVC Ratio at all time points through Week 24
*Percentage change from baseline in pre-bronchodilator FEV1 at all time points through Week24
*Change from baseline in pre-bronchodilator FEV1 at Week 12
*Change from baseline in Asthma Control Questionnaire-5 (ACQ-5) total score at Week 12
*Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) global score at 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

+81-3-6665-0572

May. 09, 2025

Yes

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

China/United States