NIPH Clinical Trials Search

A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Chronic Obstructive Pulmonary Disease
Date of first enrollment	15/04/2026
Target sample size	1156
Countries of recruitment	United States,Japan
Study type	Interventional
Intervention(s)	Phase 2 Treatment Arm A: PF-07275315 dose 1 -SC injection Phase 2 Treatment Arm B: PF-07275315-dose 2 -SC injection Phase 2 Treatment Arm C: Placebo -SC injection matched Phase 3 Treatment Arm A: PF-07275315-dose 3 -SC injection Phase 3 Treatment Arm B: Placebo -SC injection matched

Outcome(s)

Primary Outcome

*Phase 2 part: Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24 *Phase 3 part: Annualized rate of moderate or severe ECOPD

Secondary Outcome

Phase 2 part: *Annualized rate of moderate or severe ECOPD *Change from baseline in pre-BD FEV1 up to Week 24 *Change from baseline in trough, pre- and post-BD FEV1 up to Week 24 *Change from baseline in trough, pre- and post-BD FVC and FEV1/FVC ratio, % predicted FEV1, % predicted FVC up to Week 24 *Change from baseline in trough FEV1 responsiveness to BD up to Week 24 *Incidence and severity of TEAEs throughout Phase 2 part of the study *Incidence of treatment-emergent adverse events and serious adverse events leading to discontinuation *Incidence of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs *Change from baseline in clinical laboratory values, ECG measurements, and vital signs Phase 3 part: *Change from baseline in pre- and post-BD FEV1 at Week 12 and Week 52 *Percentage of participants with >=4 points improvement from baseline in Saint George's Respiratory Questionnaire (SGRQ) score at Week 52 *Percentage of participants with >=2 points improvement from baseline in the COPD Assessment Test (CAT) total score at Week 52 *Percentage of participants with >=2 points improvement from baseline in E-RS:COPD total score at Week 52 *Annualized rate of severe ECOPD *Annualized rate of exacerbations requiring emergency department visit and/or hospitalization

Key inclusion & exclusion criteria

Age minimum	>= 35age old
Age maximum	<= 80age old
Gender	Both
Include criteria	*Diagnosis of chronic obstructive pulmonary disease (COPD) for at least 12 months (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition). *Spirometry values (post-bronchodilator forced expiratory volume in 1 second [FEV1]/forced vital capacity [FVC] less than [<] 70 percent (%) and post-bronchodilator FEV1 % predicted <=70%, but greater than equal to 30%). *Continuous treatment with standard of care triple therapy of LABA + LAMA + ICS for >= 6 months prior to Screening Visit 1 and at a stable dose for >=3 months *Documented history of at least 2 moderate or severe ECOPD within the last 12 months prior to Screening.
Exclude criteria	*Significant pulmonary disease other than COPD. *Requirement for continuous chronic treatment with oxygen at >4.0 liters / minute by nasal cannula or equivalent. *Hypoxemia with a resting SpO2 <88% while breathing ambient air (or on the participant's usual level of oxygen supplementation). *Clinically significant cardiovascular disease, acute and/or severe left heart failure, or heart failure partial ejection fraction, and/or cor pulmonale.