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

Pfizer

Status and phase: Not yet enrolling; Phase 3

Conditions: Moderate to Severe Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: PF-07275315-dose 2; Drug: PF-07275315 dose 1; Drug: PF-07275315-dose 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT07363694

C4531031

2024-518587-12-00 (Registry Identifier)

Details and patient eligibility

About

The purpose of this clinical trial is to learn about the effects and safety of the study medicine PF-07275315 for the potential treatment of COPD. COPD is a condition that makes it difficult to breathe, which negatively impacts the quality of life and functioning of people who are affected.

This study is seeking participants who:

• Are 35 to 80 years old
• Have had moderate-to-severe COPD for at least 12 months
• Have a documented history of at least 2 moderate or severe exacerbations within the last 12 months
• Have been continuously taking their regular maintenance treatment(s) for COPD over at least 6 months at a stable dose for 3 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 24 weeks for the Phase 2 part and 52 weeks for the Phase 3 part. We will compare the results 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 who will be involved in the Phase 2 part of the study for about 40 weeks. During this time, they will have 11 visits at the study clinic.

Participants who will be involved in the Phase 3 part of the study for about 68 weeks. During this time, they will have 18 visits at the study clinic.

Enrollment: 1,156 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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 [<] 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.

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,156 participants in 5 patient groups, including a placebo group

Phase 2 Treatment Arm A

Experimental group

Treatment:

Drug: PF-07275315 dose 1

Phase 2 Treatment Arm B

Experimental group

Treatment:

Drug: PF-07275315-dose 2

Phase 2 Treatment Arm C

Placebo Comparator group

Treatment:

Drug: Placebo

Phase 3 Treatment Arm A

Experimental group

Treatment:

Drug: PF-07275315-dose 3

Phase 3 Treatment Arm B

Placebo Comparator group

Treatment:

Drug: Placebo