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A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-to-Severe Asthma
EU CTIS ID: 2024-517866-40-00
What this study is testing
To assess the efficacy of PF-07275315 compared to placebo in participants with moderate-to-severe asthma and with eosinophil counts ≥ 300 cells/μL. To assess the safety of PF-07275315 in participants with moderate-to-severe asthma
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 to 70 years of age (or the minimum age of consent in accordance with local regulations) at screening.
- History of persistent, moderate-to-severe asthma for at least 12 months prior to screening and have experienced at least 1 asthma exacerbation requiring treatment with systemic steroids (oral or parenteral) for 3 days or more within 12 months of the screening visit.
- Must have a history of bronchodilator responsiveness or positive methacholine challenge test confirming an asthma diagnosis.
- At least 2 of the 3 pre-bronchodilator FEV1 values collected between Week-2 and Week 0 (Visits 2 through 4) and the mean of the pre-bronchodilator FEV1 values collected between Week-2 and Week 0 are ≥30% to <80% of predicted normal values.
- Positive bronchodilator responsiveness as evidenced by increase in FEV1 of at least 12% and 200 mL, at 15 - 30 minutes (or consistent with local treatment practices after inhaling 400 μg of salbutamol / albuterol (or equivalent Short-Acting Beta-Agonists [SABA]) at least once for spirometry conducted during screening period (Visit 1, Visit 2, or Visit 3).
- Maintenance (controller) treatment that minimally includes a medium to high dose inhaled corticosteroids - long-acting beta 2 agonists (ICS -LABA) combination consistent with Global Initiative for Asthma (GINA) Step 4/5 (either Track 1 or Track 2) for 12 months prior to the screening visit and at a stable dose for at least 3 months prior to the screening visit.
You likely can't join if
- Evidence of lung disease(s) other than asthma, either clinical evidence, spirometry, or imaging (Chest X-ray, computed tomography [CT], magnetic resonance imaging [MRI]) within 12 months of the screening visit, as per local standard of care.
- Chronic obstructive pulmonary disease or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, sarcoidosis) which may impair lung function tests.
- Diagnosed with any acute or chronic infections or infection history.
- Prior or current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
- Treatment with any dose level of systemic (oral, injectable, or intraarticular) corticosteroids within 28 days of the screening visit.
- Prior or concurrent treatment with either approved or experimental biologics (such as inhibitors of IL-4Rα, TSLP, IL-5, OX40/OX40L, or IgE) or targeted synthetic drugs (such as JAK inhibitors) for the treatment of asthma or other type 2 inflammatory diseases including but not limited to: atopic dermatitis (AD), eosinophilic esophagitis (EoE), chronic rhinosinusitis (CRS).
See the full eligibility criteria
Who can join
- 18 to 70 years of age (or the minimum age of consent in accordance with local regulations) at screening.
- History of persistent, moderate-to-severe asthma for at least 12 months prior to screening and have experienced at least 1 asthma exacerbation requiring treatment with systemic steroids (oral or parenteral) for 3 days or more within 12 months of the screening visit.
- Must have a history of bronchodilator responsiveness or positive methacholine challenge test confirming an asthma diagnosis.
- At least 2 of the 3 pre-bronchodilator FEV1 values collected between Week-2 and Week 0 (Visits 2 through 4) and the mean of the pre-bronchodilator FEV1 values collected between Week-2 and Week 0 are ≥30% to <80% of predicted normal values.
- Positive bronchodilator responsiveness as evidenced by increase in FEV1 of at least 12% and 200 mL, at 15 - 30 minutes (or consistent with local treatment practices after inhaling 400 μg of salbutamol / albuterol (or equivalent Short-Acting Beta-Agonists [SABA]) at least once for spirometry conducted during screening period (Visit 1, Visit 2, or Visit 3).
- Maintenance (controller) treatment that minimally includes a medium to high dose inhaled corticosteroids - long-acting beta 2 agonists (ICS -LABA) combination consistent with Global Initiative for Asthma (GINA) Step 4/5 (either Track 1 or Track 2) for 12 months prior to the screening visit and at a stable dose for at least 3 months prior to the screening visit.
- Body mass index between 18-40 kg/m2 at screening
- ACQ-5 score of ≥1.5 at screening visit and prior to randomization (on at least 1 of the Week -2, Week -1 or Day 1 [pre-dose] visits).
What rules you out
- Evidence of lung disease(s) other than asthma, either clinical evidence, spirometry, or imaging (Chest X-ray, computed tomography [CT], magnetic resonance imaging [MRI]) within 12 months of the screening visit, as per local standard of care.
- Chronic obstructive pulmonary disease or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, sarcoidosis) which may impair lung function tests.
- Diagnosed with any acute or chronic infections or infection history.
- Prior or current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
- Treatment with any dose level of systemic (oral, injectable, or intraarticular) corticosteroids within 28 days of the screening visit.
- Prior or concurrent treatment with either approved or experimental biologics (such as inhibitors of IL-4Rα, TSLP, IL-5, OX40/OX40L, or IgE) or targeted synthetic drugs (such as JAK inhibitors) for the treatment of asthma or other type 2 inflammatory diseases including but not limited to: atopic dermatitis (AD), eosinophilic esophagitis (EoE), chronic rhinosinusitis (CRS).
- Cigarette smoking history of ≥10 pack-years.
- Active smoking or vaping within 12 months of the screening visit.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Korea, Republic of
- China
- United States
- South Africa
- Argentina
- Japan
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Korea, Republic of; China; United States; South Africa; Argentina and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.