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

Korábbi kezelés

• 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-4, IL-13, IL-33/ST2, 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: AD, EoE, CRS.
• Treatment with any dose level of systemic (oral, injectable, or intraarticular) corticosteroids within 28 days of the screening visit.
• Prior (within 12 weeks prior to screening) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig).
• 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.

Más betegség

• Medical Conditions:
• 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
• History of anaphylaxis to antibody therapeutic or to PF-07275315 or to the excipients of the formulated drug products.

Laborértékek

• 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.

• 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 24 months of the screening visit.
• At least 2 of the 3 pre-bronchodilator FEV1 values collected in the run-in period and the mean of the of pre-bronchodilator FEV1 values collected in the run-in period are ≥30% to <80% of predicted normal values.
• 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 6 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 Inclusion Criteria:
• Body mass index between 18 -40 kg/m2 at screening.