Phase
Condition
Asthma
Treatment
Placebo
PF-07275315
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must meet the following asthma criteria:
History of persistent, moderate-to-severe asthma for at least 12 months prior toscreening.
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.
Pre-bronchodilator FEV1 of ≥30% to <80% of predicted normal values during screeningperiod.
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 12months prior to the screening visit and at a stable dose for at least 3 months priorto 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.
Exclusion
Exclusion Criteria:
Medical Conditions:
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.
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
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:
Prior or current use of any prohibited concomitant medication(s) or unwillingness orinability to use a required concomitant medication(s).
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.
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).
Prior (within 12 weeks prior to screening) or planned concomitant treatment withimmunoglobulin supplementation (eg, IV Ig or SC Ig).
History of anaphylaxis to antibody therapeutic or to PF-07275315 or to theexcipients 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 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
Connect with a study center
Velocity Clinical Research, Mobile
Mobile, Alabama 36608
United StatesSite Not Available
Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California 95117
United StatesActive - Recruiting
Allergy & Asthma Clinical Research
Walnut Creek, California 94598
United StatesSite Not Available
Circuit Clinical / Impact Medical Allergy, Asthma & Immunology
Riverdale, New Jersey 07457
United StatesSite Not Available
Allergy, Asthma and Clinical Research
Oklahoma City, Oklahoma 73120
United StatesSite Not Available
Clinical Research of Rock Hill
Rock Hill, South Carolina 29732
United StatesSite Not Available
Greater Heights & Memorial Pulmonary and Sleep
Houston, Texas 77008
United StatesSite Not Available
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