Status:
RECRUITING
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Lead Sponsor:
Pfizer
Conditions:
Asthma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) for the potential treatment of moderate-to-severe asthma. Asthma is a condition t...
Eligibility Criteria
Inclusion
- Must meet the following asthma criteria:
- History of persistent, moderate-to-severe asthma for at least 12 months prior to screening.
- Must 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.
- Pre-bronchodilator FEV1 of ≥30% to \<80% of predicted normal values during screening period.
- Positive bronchodilator responsiveness as evidenced by increase in FEV1 of at least 12% and 200 mL for spirometry conducted during screening period.
- Maintenance (controller) treatment that minimally includes a medium to high dose ICS - LABA combination consistent with 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.
- ACQ-5 score of ≥1.5 at screening visit and prior to randomization.
- Other
- Body mass index between 18 40 kg/m2 at screening.
Exclusion
- Medical Conditions:
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Evidence of lung disease(s) other than asthma, either clinical evidence, spirometry, or imaging (Chest X-ray, CT, MRI) within 12 months of the screening visit, as per local standard of care, including but not limited to: Chronic obstructive pulmonary disease, Other emphysematous lung disease such as alpha-1 antitrypsin disease, Cystic fibrosis, Emphysema, Idiopathic pulmonary fibrosis, Churg-Strauss syndrome, Allergic bronchopulmonary aspergillosis, Sarcoidosis
- Diagnosed with any of the following acute or chronic infections or infection history:
- Active helminth or parasitic infection requiring treatment within 2 weeks prior to screening;
- Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1;
- Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1.
- Prior/Concomitant Therapy:
- Prior or current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
- Prior or concurrent treatment with either approved or experimental biologic treatment (such as inhibitors of IL-4Rα, TSLP, IL-5, 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: AD, EoE, CRS.
- Treatment with any dose level of systemic (oral or injectable) corticosteroids within 28 days of the screening visit through the end of study (except to treat an acute exacerbation).
- Prior (within 12 weeks prior to screening) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig).
- History of anaphylaxis to antibody therapeutic or to PF-07275315 or to the excipients of the formulated drug products.
- Bronchial thermoplasty within the previous 24 months.
- Prior/Concurrent Clinical Study Experience:
- Administration of an investigational drug product within 30 days or 5 half lives preceding the screening visit (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2027
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT06977581
Start Date
May 20 2025
End Date
August 15 2027
Last Update
June 15 2025
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Velocity Clinical Research, Mobile
Mobile, Alabama, United States, 36608
2
Antelope Valley Clinical Trials
Lancaster, California, United States, 93534
3
Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States, 95117
4
Allergy & Asthma Clinical Research
Walnut Creek, California, United States, 94598