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

AN INTERVENTIONAL PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY-UNBLINDED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) - COPD

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2061250099
Enrollment
1156
Registered
2026-03-13
Start date
2026-04-15
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

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-0

Sponsors

Kawai Norisuke
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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 [= 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
*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

MeasureTime frame
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

Countries

Canada, China, India, Japan, South Korea, Taiwan, United States

Contacts

Public ContactClinical Trials Information Desk

Pfizer R&D Japan G.K.

clinical-trials@pfizer.com+81-3-5309-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026