A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-to-Severe Asthma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

29 Sep 2025 → ongoing

Decision date (initial)

2025-08-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Pfizer Inc., 66 Hudson Boulevard East, New York, NY 10001, USA

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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

Secondary objectives 5

1. To assess additional efficacy measures of PF-07275315 compared to placebo in participants with moderate-to-severe asthma and with eosinophil counts ≥300 cells/μL.
2. To assess the efficacy of PF-07275315 compared to placebo in participants with moderate-to-severe asthma, and with eosinophil counts <300 cells/μL
3. To assess the efficacy of PF-07275315 compared to placebo in participants with moderate-to-severe asthma, irrespective of baseline eosinophil counts.
4. To assess the effect on quality of life of PF-07275315 in participants with moderate-to-severe asthma and with eosinophil counts ≥300 cells/μL.
5. To assess the efficacy of PF-07275315 compared to placebo in participants with moderate-to-severe asthma and with FeNO ≥25 ppb and < 25 ppb.

Conditions and MedDRA coding

Moderate-to-severe Asthma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 18 to 70 years of age (or the minimum age of consent in accordance with local regulations) at screening.
2. 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.
3. Must have a history of bronchodilator responsiveness or positive methacholine challenge test confirming an asthma diagnosis.
4. 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.
5. 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).
6. 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.
7. Body mass index between 18-40 kg/m2 at screening
8. 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).

Exclusion criteria 8

1. 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.
2. 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.
3. Diagnosed with any acute or chronic infections or infection history.
4. Prior or current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
5. Treatment with any dose level of systemic (oral, injectable, or intraarticular) corticosteroids within 28 days of the screening visit.
6. 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).
7. Cigarette smoking history of ≥10 pack-years.
8. Active smoking or vaping within 12 months of the screening visit.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. Change from baseline (CFB) in pre-bronchodilator forced expiratory volume (in mL) in one second (FEV1) at Week 12.
2. Incidence of treatment-emergent adverse events (TEAEs, all causality and treatment-related).
3. Incidence of treatment-emergent serious adverse events (SAEs).
4. Discontinuations due to TEAEs or SAEs.
5. Clinically significant, treatment-related abnormal laboratory values, vital signs or electrocardiograms.

Secondary endpoints 9

1. Key Secondary: • CFB in pre-bronchodilator % predicted FEV1, at Week 12.
2. Other Secondary: CFB in pre-bronchodilator lung function parameters (ie, FEV1 *, % predicted FEV1*, Forced vital capacity [FVC], % predicted FVC, FEV1/FVC ratio) at all other time points.
3. CFB in post-bronchodilator lung function parameters (ie, FEV1 , % predicted FEV1 (all time points except Week 12), FVC , % predicted FVC, FEV1/FVC ratio) at all other time points.
4. Percentage CFB in pre-BD FEV1 at all time points.
5. CFB in pre-bronchodilator FEV1 at Week 12.
6. CFB in pre-bronchodilator FEV1 at Week 12.
7. CFB in asthma control questionnaire (5-question version [ACQ-5]) total score at Week 12.
8. CFB in asthma quality of life questionnaire with standardized activities (AQLQ) self-administered global score at Week 12.
9. CFB in pre- bronchodilator FEV1 at Week 12.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Third parties 7

Locations

7 EU/EEA countries · 36 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 105 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications