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

Last updated: May 14, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

2

Condition

Asthma

Treatment

Placebo

PF-07275315

Clinical Study ID

NCT06977581
C4531029
2024-517866-40-00
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Must meet the following asthma criteria:

  1. History of persistent, moderate-to-severe asthma for at least 12 months prior toscreening.

  2. Must have experienced at least 1 asthma exacerbation requiring treatment withsystemic steroids (oral or parenteral) for 3 days or more within 12 months of thescreening visit.

  3. Pre-bronchodilator FEV1 of ≥30% to <80% of predicted normal values during screeningperiod.

  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 12months prior to the screening visit and at a stable dose for at least 3 months priorto the screening visit.
  1. ACQ-5 score of ≥1.5 at screening visit and prior to randomization. Other Inclusion Criteria:

  2. Body mass index between 18 40 kg/m2 at screening.

Exclusion

Exclusion Criteria:

Medical Conditions:

  1. Any medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may increase therisk of study participation or, in the investigator's judgment, make the participantinappropriate 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 perlocal standard of care, including but not limited to: Chronic obstructive pulmonarydisease, 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 infectionhistory:

  • Active helminth or parasitic infection requiring treatment within 2 weeks priorto screening;

  • Infection requiring hospitalization or systemic (parenteral) antimicrobialtherapy within 60 days prior to Day 1;

  • Any infection judged to be an opportunistic infection or clinically significantby the investigator, within 6 months prior to Day 1. Prior/Concomitant Therapy:

  1. Prior or current use of any prohibited concomitant medication(s) or unwillingness orinability to use a required concomitant medication(s).

  2. Prior or concurrent treatment with either approved or experimental biologictreatment (such as inhibitors of IL-4Rα, TSLP, IL-5, or IgE) or targeted syntheticdrugs (such as JAK inhibitors) for the treatment of asthma or other type 2inflammatory diseases, including but not limited to: AD, EoE, CRS.

  3. Treatment with any dose level of systemic (oral or injectable) corticosteroidswithin 28 days of the screening visit through the end of study (except to treat anacute exacerbation).

  4. Prior (within 12 weeks prior to screening) or planned concomitant treatment withimmunoglobulin supplementation (eg, IV Ig or SC Ig).

  5. History of anaphylaxis to antibody therapeutic or to PF-07275315 or to theexcipients of the formulated drug products.

  6. Bronchial thermoplasty within the previous 24 months. Prior/Concurrent Clinical Study Experience:

  7. Administration of an investigational drug product within 30 days or 5 half livespreceding the screening visit (whichever is longer). Participation in studies ofother investigational products (drug or vaccine) at any time during participation inthis study.

Study Design

Total Participants: 252
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
May 22, 2025
Estimated Completion Date:
July 26, 2027

Connect with a study center

  • Velocity Clinical Research, Mobile

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Allergy and Asthma Associates of Santa Clara Valley Research Center

    San Jose, California 95117
    United States

    Active - Recruiting

  • Allergy & Asthma Clinical Research

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Circuit Clinical / Impact Medical Allergy, Asthma & Immunology

    Riverdale, New Jersey 07457
    United States

    Site Not Available

  • Allergy, Asthma and Clinical Research

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

  • Greater Heights & Memorial Pulmonary and Sleep

    Houston, Texas 77008
    United States

    Site Not Available

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