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NCT06977581 | RECRUITING | Asthma

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

Pfizer

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 that makes it challenging to breathe, which negatively impacts the quality of life and functioning of people who are affected. 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.

Condition or disease

Asthma

Intervention/treatment

PF-07275315

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 252 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Dose-Ranging Study to Investigate the Efficacy and Safety of PF-07275315 in Adult Participants With Inadequately Controlled Moderate-to-Severe Asthma
Actual Study Start Date : 2025-05-20
Estimated Primary Completion Date : 2027-03-28
Estimated Study Completion Date : 2027-08-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • Must meet the following asthma 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.
    • Other Inclusion Criteria:
    • 7. Body mass index between 18 40 kg/m2 at screening.
    Exclusion Criteria
    • Medical Conditions
      • 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.
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma

Location Details

NCT06977581

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Albama

Velocity Clinical Research, Mobile

Mobile, Albama, United States, 36608

RECRUITING

United States, California

Antelope Valley Clinical Trials

Lancaster, California, United States, 93534

RECRUITING

United States, California

Allergy and Asthma Associates of Santa Clara Valley Research Center

San Jose, California, United States, 95117

RECRUITING

United States, California

Allergy & Asthma Clinical Research

Walnut Creek, California, United States, 94598

NOT YET RECRUITING

United States, New Jersey

Circuit Clinical / Impact Medical Allergy, Asthma & Immunology

Riverdale, New Jersey, United States, 07457

NOT YET RECRUITING

United States, Oklahola

OK Clinical Research

Edmond, Okholohan, United States, 73034

RECRUITING

United States, Oklahola

Allergy, Asthma and Clinical Research

Ololama City, Okholohan, United States, 73120

NOT YET RECRUITING

United States, South Carolina

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States, 29732

NOT YET RECRUITING

United States, Tennessee

Premier Research Center, LLC

Hendersonville, Tennessee, United States, 37075

NOT YET RECRUITING

United States, Texas

Alina Clinical Trials, LLC.

Dallas, Texas, United States, 75209

RECRUITING

United States, Texas

Greater Heights & Memorial Pulmonary and Sleep

Houston, Texas, United States, 77008

NOT YET RECRUITING

China, Guangdong

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510150

NOT YET RECRUITING

China, Shanghai Municipality

Shanghai General Hospital

Shanghai, Shanghai Municipality, China, 200080

NOT YET RECRUITING

Japan, Osaka

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, Osaka, Japan, 586-8521

NOT YET RECRUITING

Japan, Osaka

NHO KINKI College Chest Medical Center

Sakai, Osaka, Japan, 591-8555

NOT YET RECRUITING

Japan, Tokyo

Fukuwa Clinic

C-Cry, Tokyo, Japan, 104-0031