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Study of PF-07275315 versus placebo for efficacy and safety in adults with moderate-to-severe chronic obstructive pulmonary disease (COPD)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at adults who have Chronic Obstructive Pulmonary Disease that is moderate‑to‑severe, meaning they have long‑term breathing difficulty that is not mild. The medicine being tested is called PF-07275315, which is given as a small injection under the skin (subcutaneous). Participants will receive either this medicine or a placebo, which looks the same but does not contain the active drug.

The purpose of the study is to find out whether the new medicine can improve breathing and reduce serious flare‑ups compared with the placebo. People who join will be randomly assigned to one of the two groups, and neither the participants nor the study staff will know which treatment each person receives (double‑blind). Over several months, participants will come to the clinic for routine visits where their lung function, symptoms and overall health will be checked.

During the study, participants will receive the injections at set intervals and will have simple breathing tests, such as measuring forced expiratory volume in one second (FEV1), which shows how much air can be exhaled quickly. They will also answer short questionnaires about how they feel, and will have basic safety checks like blood tests and a quick heart rhythm check (ECG). All of this information helps researchers see if the medicine works and is safe.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and first injection

    After joining the study you are assigned, without knowing which you receive, to either the pf-07275315 injection or a placebo injection. the injection is given subcutaneously, meaning it is placed under the skin, as a solution for injection. the exact dose is determined by the study protocol.

    The first injection occurs at the baseline visit, which is considered week 0.

  2. Step 2

    Regular treatment period (phase 2)

    If you are in the phase 2 portion of the trial, you continue to receive the assigned injection at the schedule defined by the study for a total of 24 weeks.

    Each injection is given subcutaneously at the study site. the frequency of injections (for example weekly or every two weeks) follows the study protocol.

    Throughout the 24‑week period you attend scheduled visits where lung function tests and safety assessments are performed.

  3. Step 3

    Regular treatment period (phase 3)

    If you are in the phase 3 portion of the trial, you continue to receive the assigned injection for up to 52 weeks.

    The injection is administered subcutaneously according to the study schedule, and you attend regular visits for lung function testing and safety monitoring.

    Key assessments are made at week 12 and week 52 to evaluate the effect of the medicine.

  4. Step 4

    Interim assessments

    At predetermined visits (for example at weeks 4, 12, and 24 in phase 2, and at weeks 12 and 52 in phase 3) you undergo measurements of forced expiratory volume in one second (fev1) before and after using a bronchodilator, as well as other lung capacity tests.

    These assessments help determine how the medication is affecting breathing ability.

  5. Step 5

    End of treatment and final evaluation

    At the end of the treatment period (week 24 for phase 2 or week 52 for phase 3) you receive a final injection and complete the last set of study visits.

    Final evaluations include lung function tests, questionnaires about respiratory symptoms, and safety checks to record any adverse events.

  6. Step 6

    Post‑treatment follow‑up

    After the final visit you may be asked to return for a short follow‑up visit to confirm that any study‑related effects have resolved.

    No study medication is given after this point.

Who can join the trial?

9 criteria

  • Age: You must be between 35 and 80 years old at the screening visit, and if you can become pregnant you need to use a highly effective birth‑control method.
  • COPD diagnosis: You must have been diagnosed with chronic obstructive pulmonary disease (COPD) for at least one year according to the current GOLD definition.
  • Lung function test: After using a bronchodilator medication, your test must show an FEV1/FVC ratio (the amount of air you can force out in one second divided by the total amount you can exhale) of less than 0.7, and your FEV1 (the volume of air you can force out in one second) must be between 30 % and 70 % of the normal value predicted for someone of your age, sex and size.
  • CAT score: Your COPD Assessment Test score must be 15 or higher at least once during the first three visits, and every CAT score must be greater than 10.
  • Blood eosinophil count: One of your screening blood tests must show at least 150 eosinophils (a type of white blood cell) per microliter.
  • Standard COPD medicines: You must have been taking the usual COPD therapy continuously for at least six months before screening, and at a stable dose for at least three months. This usually means a “triple therapy” combination of LABA (long‑acting beta‑agonist), LAMA (long‑acting muscarinic antagonist) and ICS (inhaled corticosteroid). If inhaled steroids are not allowed for you, a “double therapy” of LABA + LAMA is acceptable.
  • Smoking history: You must be a current or former smoker with a history of at least 10 pack‑years (the equivalent of smoking one pack per day for ten years). Former smokers must have not used any tobacco product for at least six months before the first visit. Only cigarette use counts; cigars, pipes, chewing tobacco, vaping or similar products are not included.
  • Exacerbations: In the 12 months before the first visit you must have had at least two moderate or severe COPD flare‑ups. A moderate exacerbation is a worsening that needs oral or injected steroids and/or antibiotics for at least three days. A severe exacerbation requires a hospital stay or emergency/urgent‑care treatment lasting 24 hours or more. One of these events must have been treated with systemic steroids, and one must have occurred while you were using triple therapy (unless steroids were not allowed for you).
  • BMI: Your body‑mass index must be between 18 and 40 kilograms per square meter (kg/m²), inclusive.

Who cannot join the trial?

34 criteria

  • Extensive emphysema (about 25% or more of one side of the chest filled with damaged air spaces) shown on a chest X‑ray, CT scan, or MRI within the past 24 months.
  • Significant eye inflammation such as conjunctivitis or other surface eye problems.
  • Any infection that needed treatment with antivirals, antibiotics, antifungals, antiparasitics, or antiprotozoal medicines within the last 4 weeks.
  • History of having a lung removed (pneumonectomy) or other lung surgery, or lung‑volume‑reduction surgery within the past 12 months or planned during the study.
  • Starting a pulmonary rehabilitation program within the past 6 months or planning to start one during the study (being in the maintenance phase of such a program is allowed).
  • Heart rhythm problems (cardiac arrhythmias), including intermittent (paroxysmal) atrial fibrillation, unless it is a stable, long‑standing form that is well‑controlled.
  • Clinically important heart disease such as severe left‑hand heart failure, heart failure with preserved ejection fraction (HFpEF), or cor pulmonale (right‑hand heart problems caused by lung disease).
  • Any significant medical or psychiatric condition, or abnormal lab result, that the doctor thinks makes participation unsafe.
  • Use of any medication that is not allowed in the study, or inability/refusal to take required study medicines.
  • For Phase 3 only: having already taken part in Phase 2 of this same study.
  • Current or past treatment with approved or experimental biologic drugs for type 2 inflammatory diseases (for example, certain allergy, asthma, or sinus conditions).
  • History of a severe allergic reaction (anaphylaxis) to antibody medicines, PF‑07275315, or any ingredient in the study drug.
  • Receiving any investigational drug or vaccine within 30 days (or five drug half‑lives) before the screening visit.
  • Specific lab abnormalities at screening, such as:
    • High bilirubin (≥1.5 times the normal limit) or high liver enzymes (AST or ALT ≥2.5 × normal);
    • Low white blood cell count (ANC ≤1500 cells/mm³);
    • Low platelets (≤100,000/mm³);
    • Low hemoglobin (≤9.0 g/dL for females, ≤10.0 g/dL for males);
    • Active or latent tuberculosis;
    • Active or latent HIV, hepatitis B, or hepatitis C.
    • An abnormal baseline 12‑lead ECG (heart electrical test) showing serious problems such as:
      • QTcF interval > 450 ms (a measure of heart repolarization);
      • Complete left bundle‑branch block (LBBB);
      • Signs of a recent heart attack;
      • Significant AV block (second‑ or third‑degree);
      • Severe slow (bradyarrhythmia) or fast (tachyarrhythmia) heart rates.
      • Failure to complete at least 4 out of 7 days (about 57%) of the symptom diary and medication log during the screening period.
      • Being a study site staff member, a family member of staff, or an employee of the sponsor directly involved in the study.
      • Being currently pregnant, breastfeeding, or planning to become pregnant during the study.
      • Having pulmonary arterial hypertension (PAH) caused by COPD.
      • Chronic respiratory failure with high carbon dioxide levels that needs non‑invasive ventilation such as BiPAP.
      • Needing continuous oxygen therapy at more than 4 L/min for more than 12 hours per day, or using high‑flow or non‑rebreathing masks.
      • Low blood oxygen level (SpO₂ < 88 %) while breathing normal air (or usual oxygen level), measured at rest.
      • Severe sleep apnea that requires BiPAP or is linked to significant pulmonary hypertension.
      • Autoimmune or autoinflammatory diseases that require strong immune‑suppressing medicines.
      • Recent COPD flare‑up, upper or lower respiratory infection, pneumonia, or hospital stay for COPD worsening lasting 24 hours or more within the past 4 weeks.
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Investigated drugs

PF-07275315 is an experimental medicine being studied to see if it can help adults with moderate‑to‑severe chronic obstructive pulmonary disease (COPD). In this trial the drug is given as a liquid that is injected under the skin (subcutaneously). Researchers are testing whether the medicine can improve breathing, reduce symptoms, and lower the number of flare‑ups compared with a placebo. The study will look at how well the drug works and whether it is safe for people with COPD.

What is already known about the treatment

  • PF-07275315

    This drug is given as a subcutaneous injection in a liquid solution. It is still investigational and has not been approved for general medical use, being studied in clinical trials for moderate‑to‑severe chronic obstructive pulmonary disease (COPD). The medication works by blocking specific signals that cause airway inflammation, helping to keep the lungs clearer. It is classified as an experimental anti‑inflammatory agent for respiratory disease.

  • Placebo

    The placebo is also administered as a subcutaneous injection of a sterile solution that contains no active medicine. It is used only as a control in the trial to compare the effects of the active drug. Because it has no therapeutic ingredient, it does not treat any condition. It is considered an inactive comparator in clinical research.

Investigated diseases

Chronic obstructive pulmonary disease - A long‑lasting lung condition that makes it hard to breathe because the airways become narrowed and the lung tissue loses its elasticity. Over time, the airflow limitation worsens, causing increasing shortness of breath, coughing, and difficulty clearing mucus. The disease often starts with mild symptoms and gradually progresses to more noticeable breathing problems, especially during physical activity. Episodes of worsening symptoms, called exacerbations, can occur and may lead to further decline in lung function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518587-12-00Protocol codeC4531031Estimated enrolment1 056 patientsSponsorPfizer Inc.

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