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

NCT07363694
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Phase
Phase 2/Phase 3
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Recruitment status
Recruiting
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Participants
1,156
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Lead sponsor
Pfizer
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Start date
2026-02-11
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Number of sites
103
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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.
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Acronym
COPD
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Short title
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease
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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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2/Phase 3
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Study type
Interventional
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Completion date
2031-01-16
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First posted
2026-01-23
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Registry last updated
2026-07-27
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Primary completion date
2030-10-24
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Start date
2026-02-11
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Participants
1,156
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Participant count basis
Estimated
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Planned participants
1,156
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Protocol amendments
2
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Number of sites
103
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Pfizer
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07363694
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ClinicalTrials.gov ID
NCT07363694
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
All dosing syringes will be masked and an unblinded administrator will administer the study intervention.
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Phase 2 part: Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24

    Timeframe: Baseline to Week 24

    FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 is obtained from spirometry.

  2. Phase 3 part: Annualized rate of moderate or severe ECOPD

    Timeframe: Baseline to Week 52

    Exacerbation of Chronic Obstructive Pulmonary Disease (ECOPD) are sudden worsening of respiratory symptoms that significantly worsen lung function and quality of life.

  1. Phase 2: Annualized rate of moderate or severe ECOPD.

    Timeframe: Baseline to Week 24

  2. Phase 2: Change from baseline in pre-BD FEV1 up to Week 24.

    Timeframe: Baseline to Week 24

  3. Phase 2: Change from baseline in trough, pre- and post-BD FEV1 up to Week 24

    Timeframe: Baseline to Week 24

  4. Phase 2: Change from baseline in trough, pre- and post-BD FVC and FEV1/FVC ratio, % predicted FEV1, % predicted FVC up to Week 24.

    Timeframe: Baseline to Week 24

  5. Phase 2: Change from baseline in trough FEV1 responsiveness to BD up to Week 24.

    Timeframe: Baseline to Week 24

  6. Phase 2: Incidence and severity of TEAEs throughout Phase 2 part of the study.

    Timeframe: Baseline to Week 24

  7. Phase 2: Incidence of treatment-emergent adverse events and serious adverse events leading to discontinuation.

    Timeframe: Baseline to Week 24

  8. Phase 2: Incidence of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs.

    Timeframe: Baseline to Week 24

  9. Phase 3: change from baseline in pre- and post-BD FEV1 at Week 12 and Week 52.

    Timeframe: Baseline to Week 52

  10. Phase 3: Percentage of participants with ≥4 points improvement from baseline in Saint George's Respiratory Questionnaire (SGRQ) score at Week 52.

    Timeframe: Baseline to Week 52

  11. Phase 3: Percentage of participants with ≥2 points improvement from baseline in the COPD Assessment Test (CAT) total score at Week 52.

    Timeframe: Baseline to Week 52

  12. Phase 3: Percentage of participants with ≥2 points improvement from baseline in E-RS:COPD total score at Week 52.

    Timeframe: Baseline to Week 52

  13. Phase 3: Annualized rate of severe ECOPD.

    Timeframe: Baseline to Week 52

  14. Phase 2: Change from baseline of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs.

    Timeframe: Baseline to Week 24

  15. Phase 3: Annualized rate of exacerbations requiring emergency department visit and/or hospitalization.

    Timeframe: Baseline to Week 52

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
35 Years
Maximum age
80 Years
Healthy volunteers
No

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.
Sources for eligibility
clinicaltrials.gov

  • University of Alabama at Birmingham Lung Health CenterBirmingham, United StatesRecruiting
  • SEC Clinical ResearchDothan, United StatesRecruiting
  • Pulmonary Associates of Mobile, P.C.Mobile, United StatesRecruiting
  • Chandler Clinical TrialsChandler, United StatesNot yet recruiting
  • Pulmonary Associates, PAPhoenix, United StatesRecruiting
  • IMAX Clinical TrialsLa Palma, United StatesRecruiting
  • NewportNativeMD, Inc.Newport Beach, United StatesRecruiting
  • California Medical Research AssociatesNorthridge, United StatesRecruiting
  • Institute of HealthCare Assessment d/b/a Apex Clinical ResearchSan Diego, United StatesRecruiting
  • Finlay Medical ResearchGreenacres City, United StatesRecruiting
  • Clinical Research Specialists LLCKissimmee, United StatesRecruiting
  • Advanced Pulmonary Research InstituteLoxahatchee Groves, United StatesRecruiting
  • Reed Medical ResearchMiami, United StatesRecruiting
  • Renstar Medical ResearchOcala, United StatesRecruiting
  • HCA Florida Ocala Imaging CenterOcala, United StatesRecruiting
  • Ocala Lung and Critical Care AssociatesOcala, United StatesRecruiting
  • Renstar Medical ResearchOcala, United StatesRecruiting
  • Coastal Medical Research Institute, LLCSt. Petersburg, United StatesRecruiting
  • Coastal Pulmonary and Critical Care, P.L.CSt. Petersburg, United StatesRecruiting
  • Clinical Research Trials of Florida, Inc.Tampa, United StatesRecruiting
  • Clinical Site Partners, LLC dba Flourish ResearchWinter Park, United StatesRecruiting
  • Cpcc-Research LlcEast Point, United StatesRecruiting
  • Centricity Research Rincon PulmonologyRincon, United StatesRecruiting
  • ASHA Clinical Research - Munster, LLCHammond, United StatesRecruiting
  • Methodist Hospital SouthlakeMerrillville, United StatesRecruiting

And 78 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-518587-12-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)