A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
NCT ID: NCT06977581
Last Updated: 2025-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
252 participants
INTERVENTIONAL
2025-05-20
2027-08-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study is seeking participants who:
* Are 18 to 70 years old
* Have had moderate-to-severe asthma for at least 12 months that is not well controlled
* Have been taking their regular maintenance treatment(s) for asthma over the last 12 months
All participants will receive PF-07275315 or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied.
PF-07275315 or placebo will be given as multiple shots in the clinic over the course of 12 weeks. We will compare the experiences of people receiving PF-07275315 to those of the people who do not. This will help us determine if PF-07275315 is safe and effective.
Participants will be involved in this study for about 9.5 months. During this time, they will have 10 visits at the study clinic.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma
NCT02219048
A Study To Examine The Safety And Efficacy Of PF-00610355 In Moderately Asthmatic Subjects
NCT00830427
A Phase IIa Repeat Dose AXP1275 vs Placebo Cross-over Trial With Pulmonary Allergen Challenge in Adults With Asthma
NCT01890161
12-Week Study in Adult Subjects With Asthma
NCT01516073
A 12-Week Study in Adult Subjects With Asthma
NCT01516086
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment Arm A
PF-07275315
PF-07275315
subcutaneous injection
Treatment Arm B
PF-07275315
PF-07275315
subcutaneous injection
Treatment Arm C
PF-07275315
PF-07275315
subcutaneous injection
Treatment Arm D
Placebo
Placebo
subcutaneous injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PF-07275315
subcutaneous injection
Placebo
subcutaneous injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. History of persistent, moderate-to-severe asthma for at least 12 months prior to screening.
2. 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.
3. Pre-bronchodilator FEV1 of ≥30% to \<80% of predicted normal values during screening period.
4. Positive bronchodilator responsiveness as evidenced by increase in FEV1 of at least 12% and 200 mL for spirometry conducted during screening period.
5. 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.
6. ACQ-5 score of ≥1.5 at screening visit and prior to randomization.
7. Body mass index between 18 40 kg/m2 at screening.
Exclusion Criteria
1. 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.
2. 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
3. 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:
4. Prior or current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
5. 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.
6. 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).
7. Prior (within 12 weeks prior to screening) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig).
8. History of anaphylaxis to antibody therapeutic or to PF-07275315 or to the excipients of the formulated drug products.
9. Bronchial thermoplasty within the previous 24 months.
Prior/Concurrent Clinical Study Experience:
10. 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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Velocity Clinical Research, Mobile
Mobile, Alabama, United States
Antelope Valley Clinical Trials
Lancaster, California, United States
Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States
Allergy & Asthma Clinical Research
Walnut Creek, California, United States
Circuit Clinical / Impact Medical Allergy, Asthma & Immunology
Riverdale, New Jersey, United States
OK Clinical Research
Edmond, Oklahoma, United States
Allergy, Asthma and Clinical Research
Oklahoma City, Oklahoma, United States
Clinical Research of Rock Hill
Rock Hill, South Carolina, United States
Premier Research Center, LLC
Hendersonville, Tennessee, United States
Alina Clinical Trials, LLC.
Dallas, Texas, United States
Greater Heights & Memorial Pulmonary and Sleep
Houston, Texas, United States
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka, Japan
NHO Kinki Chuo Chest Medical Center
Sakai, Osaka, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, Japan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-517866-40-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4531029
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.