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Study of PF-07275315 to evaluate its effectiveness and safety in adults with moderate-to-severe asthma who have high levels of eosinophils in their blood

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What is this trial about?

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

This clinical trial focuses on studying a new medication called PF-07275315 in people who have moderate-to-severe asthma. Asthma is a lung condition that makes breathing difficult and causes symptoms like wheezing, coughing, and shortness of breath. The study aims to determine how well this new medication works and how safe it is for patients whose asthma is not well controlled with their current treatments.

The study medication PF-07275315 will be given as a subcutaneous injection, which means it is injected under the skin. Some participants will receive the actual medication, while others will receive a placebo. The study will last for 12 weeks, during which participants will receive different doses of the medication or placebo.

During the study, doctors will measure how well participants' lungs are working by checking their forced expiratory volume, which shows how much air a person can breathe out in one second. They will also monitor participants' overall health and any changes in their asthma symptoms. The medication is specifically being tested in people who have higher levels of certain white blood cells called eosinophils in their blood.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your lung function will be tested using spirometry (breathing test) to measure your FEV1 (amount of air you can forcefully exhale in one second)
You will complete two questionnaires about your asthma symptoms and quality of life: the ACQ-5 (Asthma Control Questionnaire) and AQLQ (Asthma Quality of Life Questionnaire)
Step 2
Treatment assignment
You will be randomly assigned to receive either PF-07275315 or a placebo (inactive substance)
The medication will be given as an injection under the skin (subcutaneous injection)
Step 3
12-week treatment period
You will continue using your regular asthma medications, including your inhaled corticosteroids and long-acting beta agonists (ICS-LABA)
Regular breathing tests will measure your lung function
You will complete questionnaires about your asthma symptoms and quality of life
Your health will be monitored through laboratory tests, vital signs, and heart recordings (electrocardiograms)
Step 4
Final assessment
Final breathing tests will measure changes in your lung function
Final questionnaires will assess changes in your asthma control and quality of life
The study team will perform final safety assessments

Who can join the trial?

11 criteria

Age between 18 and 70 years old at screening
History of moderate-to-severe asthma for at least 12 months before screening and at least 1 asthma flare-up requiring treatment with steroids (oral or injectable) for 3 or more days within 12 months before screening
Must have documented evidence of either:
- Response to medications that open airways (bronchodilators), or
- Positive methacholine challenge test (a test that confirms asthma diagnosis)
- Lung function test (FEV1) showing between 30% and 80% of normal predicted values during screening (FEV1 measures how much air you can exhale in one second)
- Show improvement in lung function of at least 12% and 200 mL after using asthma rescue inhaler (salbutamol/albuterol)
- Currently using regular asthma medications including:
  - Medium to high dose inhaled steroids
  - Long-acting medications to open airways
  - Must be on stable doses for at least 3 months before screening
  - Body mass index (BMI) between 18 and 40 kg/m² at screening (BMI is a measure of body weight relative to height)
  - ACQ-5 score of 1.5 or higher at screening (ACQ-5 is a questionnaire that measures how well your asthma is controlled)

Who cannot join the trial?

14 criteria

Current diagnosis of chronic obstructive pulmonary disease (COPD) or other significant lung disease besides asthma
History of life-threatening asthma requiring treatment in the past 12 months
Current smokers or former smokers who quit less than 6 months ago
Pregnancy or breastfeeding women
Significant heart problems or uncontrolled high blood pressure
Active or recent serious infections
History of cancer in the past 5 years (except successfully treated skin cancer)
Current participation in other clinical trials or use of investigational drugs within 30 days
Known allergies to similar medications
Significant kidney or liver problems
Unable to use an inhaler properly or follow study procedures
Major surgery planned during the study period
History of drug or alcohol abuse within the past year
Any condition that the study doctor believes would make participation unsafe

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Verified sites

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Azienda Ospedaliera Ordine Mauriziano Di Torino
Responsive
Turin, Italy
Azienda Ospedaliera Universitaria Senese
Responsive
Siena, Italy
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain

Trial locations

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Investigated drugs

PF-07275315 is an investigational medication being studied for people with moderate to severe asthma who have high levels of eosinophils (a type of white blood cell) in their blood. This medication is being tested to see if it can help control asthma symptoms in patients whose asthma is not well controlled with their current treatments. The medication is being compared to placebo to determine how well it works and how safe it is for patients.

What is already known about the treatment

PF-07275315 - An investigational medication currently being studied in Phase 2 clinical trials for the treatment of moderate-to-severe asthma, specifically in patients with elevated eosinophil counts (≥300 cells/μL). The drug is being evaluated in a randomized, double-blind, placebo-controlled study to assess both its efficacy and safety profile in adult patients whose asthma is inadequately controlled with current treatments. While the exact mechanism of action has not been fully disclosed in the provided data, the medication is being tested as a potential new therapeutic option for patients with persistent asthma symptoms, focusing on those with an eosinophilic phenotype.

Investigated diseases

Asthma - A chronic respiratory condition that affects the airways in the lungs, causing them to become inflamed and narrow. The airways become sensitive to various triggers such as allergens, exercise, cold air, or stress, leading to recurring episodes of breathing difficulties. During an asthma episode, the muscles around the airways tighten, the airways become swollen, and excess mucus is produced, making it harder to breathe. The condition typically manifests through symptoms including wheezing, shortness of breath, chest tightness, and coughing, particularly at night or early morning. The severity of asthma can range from mild to severe, with symptoms varying in intensity and frequency over time.