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

1

What is this study about?

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.

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)

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)

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)

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy

Other Sites

Site Name City Country Status
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Alergologia Plus Sp. z o.o. Poznan Poland
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona Salerno Italy
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o. Poznan Poland
MediTrial s.r.o. Jindřichův Hradec Czechia
Medical Center Pulmo-2018 EOOD Haskovo Bulgaria
Medical Center New Rehabilitation Center EOOD Stara Zagora Bulgaria
Malopolskie Centrum Alergologii Sp. z o.o. Cracow Poland
Erzsebet Gondozohaz Kft. Godollo Hungary
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o. Tarnow Poland
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Koch Robert Korhaz Es Rendelointezet Edeleny Hungary
Infer-Med Kft. Pecs Hungary
Azienda Ospedaliera Universitaria Di Cagliari Monserrato Italy
MUDr. I. Cierna Peterova s.r.o. Brandys Nad Labem Czechia
Hospital Universitario Virgen De La Victoria Malaga Spain
DOBROSTAN Gabinety Lekarskie Wroclaw Poland
Obdjznnkg Exwwvd Ksmu Mosonmagyaróvár Hungary
Hxbqyolz Uetzbdffwxnxl Mwwkzil Dd Vrfztfltsr Santander Spain
Mkqbeqd Cgjgyy Peufvlpcefr Lkvc Sofia Bulgaria
Kifayk Mynzu Kqavuobrffi Bychawa Poland
Apitsdk Ohqrttwmyfy Ubqrielezapon Snmxyv Siena Italy
Alxhury Ufw Iicml Dy Ryyhpo Eiliny Reggio Emilia Italy
Fywjewoan Pygq Lw Irdvjgrygjyth Budwutfvt Dfu Hesilwfp Uclqzlhfhaiiu Ld Pqc Madrid Spain
Ehclkkx Mechelen Belgium
Ppeqps Gkifpdkq Gwzrlk Mepogsv Kqgpeyba srds Sosnowiec Poland
Susgep Jrsus Rslrttmxbajqpr Hajdunanas Hungary
Civvchzee swdhsq Lovosice Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
10.11.2025
Bulgaria Bulgaria
Recruiting
10.11.2025
Czechia Czechia
Recruiting
10.11.2025
Hungary Hungary
Recruiting
10.11.2025
Italy Italy
Recruiting
10.11.2025
Poland Poland
Recruiting
10.11.2025
Spain Spain
Recruiting
10.11.2025

Trial locations

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.

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.

Trial ID:
2024-517866-40-00
Protocol code:
C4531029
Trial Phase:
Therapeutic exploratory (Phase II)

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