PF-07275315: COPD Study
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 take part?
You may be able to take part if you have moderate to severe chronic obstructive pulmonary disease (COPD), a lung condition that can make breathing more difficult.
You may be eligible if you:
- Are aged 35 to 80 years
- Have had a diagnosis of COPD for at least 1 year
- Have moderate to severe COPD based on lung function tests
- Have a blood eosinophil count of 150 cells/µL or higher
- Are on stable COPD treatment (inhaled therapies) for at least 3–6 months
- Have had at least two COPD flare‑ups in the past 12 months
You would not be able to take part if:
- Have an unstable or undiagnosed medical condition
- Have another significant lung disease in addition to COPD
- Have autoimmune conditions requiring immune‑suppressing treatment (e.g. steroids, methotrexate, biologics)
- Are considered unsuitable for the study by the study doctor
What is involved?
This study is evaluating PF‑07275315, an investigational medication given as an injection under the skin, to see if it can improve lung function and reduce flare‑ups in people with COPD.
Participants will be randomly assigned (by chance) to receive PF‑07275315 or placebo. Neither you nor the study team will know which treatment you are receiving.
The study is conducted in two stages. These are separate parts of the study testing the medication at different stages:
- Stage 1 (Phase 2): looks at two different dose levels (for example, a lower dose and a higher dose), with both doses compared to a placebo to help identify the most suitable dose
- Stage 2 (Phase 3): uses the selected dose and compares it to placebo to further assess how well the medication works and its safety in a larger group of participants
If you take part in Stage 1, you will not take part in Stage 2. This is because Stage 1 is used to identify the most suitable dose, while Stage 2 confirms how well that dose works in a new group of participants.
Stage 1:
- Duration: approximately 40 weeks
- Visits: approximately 11 visits (every 3–4 weeks)
- Includes:
- Screening period (up to 4 weeks)
- Treatment period (24 weeks)
- Follow‑up period (12 weeks)
Stage 2:
- Duration: approximately 68 weeks
- Visits: approximately 18 visits (every 3–4 weeks)
- Includes:
- Screening period (up to 4 weeks)
- Treatment period (52 weeks)
- Follow‑up period (12 weeks)
Participants who complete either stage of the study and are eligible may be able to take part in a separate long‑term extension study to receive PF‑07275315.
What will I need to do?
If you take part, you will be asked to:
- Receive a study injection under the skin every 4 weeks
- Attend clinic visits and study appointments
- Record information in an electronic diary
You will also complete assessments, which may include:
- Breathing tests
- Blood tests
- Heart tracing (ECG)
- A chest X‑ray or CT scan, if you have not had one in the past 12 months
- Questionnaires about your health
More information
You can read more about this study here:
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