RightFit
RecruitingPhase 2 / Phase 3

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
35 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 11 visits, 18 visits
  • Time periods mentioned: 40 weeks, 68 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether PF-07275315 is safe and helps people with COPD, a lung disease that makes breathing hard. It is for adults ages 35 to 80 with moderate to severe COPD. Participants get shots of the study medicine or a placebo, which looks like the medicine but has no medicine in it.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 35 to 80 years old.
  • Have had COPD for at least 12 months.
  • Have breathing test results in the study's required range after taking medicine to open the airways.
  • Have taken all three required COPD treatments (LABA, LAMA, and ICS) for at least 6 months, with no dose changes for at least 3 months.
  • Have medical records showing at least 2 moderate or severe COPD flare-ups in the past 12 months.

Who can't join

  • Have a major lung disease other than COPD.
  • Need ongoing oxygen treatment at more than 4 liters per minute through nose tubes, or an equal amount by another method.
  • Have a blood oxygen level below 88% while resting, either breathing room air or using your usual oxygen.
  • Have serious heart or blood vessel disease, certain types of heart failure, or heart problems caused by lung disease.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (61)

AL

AZ

CA

FL

GA

IN

KS

LA

MA

ME

MI

MO

NC

NV

NY

OH

PA

SC

SD

TN

TX