Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:22 PM
Study NCT ID:
NCT07363694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-23
First Post:
2026-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
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)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPD
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-518587-12-00 | REGISTRY | CTIS (EU) | View |