A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Recruiting · NCT06977581 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
PF-07275315Placebo
What this trial is about
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 7.5 months. During this time, they will have 9 visits at the study clinic.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 12 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 12 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.
- ther Inclusion Criteria:
- Body mass index between 18 40 kg/m2 at screening.
Exclusion criteria
- Medical Conditions:
- 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.
- 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
- 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).
- History of anaphylaxis to antibody therapeutic or to PF-07275315 or to the excipients 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 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.
Where it is running
60 locations listed across 19 US states.
- Velocity Clinical Research, Mobile - Mobile, Alabama, United States
- Chandler Clinical Trials - Chandler, Arizona, United States
- Antelope Valley Clinical Trials - Lancaster, California, United States
- NewportNativeMD, Inc. - Newport Beach, California, United States
- California Medical Research Associates - Northridge, 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
- Colorado ENT & Allergy - Colorado Springs, Colorado, United States
- Cpcc-Research Llc - East Point, Georgia, United States
- Christie Clinic - University - Champaign, Illinois, United States
- Innovo Research - Christie Clinic - Champaign, Illinois, United States
- Christie Clinic - Windsor - Champaign, Illinois, United States
- University of Kansas Medical Center - Kansas City, Kansas, United States
- North Ingalls Building - Ann Arbor, Michigan, United States
- University of Michigan - Ann Arbor, Michigan, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Henderson Clinical Trials - Henderson, Nevada, United States
- Rutgers, Robert Wood Johnson Medical School - New Brunswick, New Jersey, United States
- Circuit Clinical / Impact Medical Allergy, Asthma & Immunology - Riverdale, New Jersey, United States
- American Health Research - Charlotte, North Carolina, United States
- Clinical Research Of Gastonia - Gastonia, North Carolina, United States
- Stern Research Partners, LLC - Huntersville, North Carolina, United States
- Toledo Institute of Clinical Research Inc. - Toledo, Ohio, United States
- OK Clinical Research - Edmond, Oklahoma, United States
- Allergy, Asthma and Clinical Research - Oklahoma City, Oklahoma, United States
- Layrek Clinical Research - Tulsa, Oklahoma, United States
- Clinical Research Associates of Central PA, LLC - DuBois, Pennsylvania, United States
- Clinical Research of Rock Hill - Rock Hill, South Carolina, United States
- Premier Research Center, LLC - Hendersonville, Tennessee, United States
- South Texas Medical Research Institute, Inc., DBA TTS Research - Boerne, Texas, United States
- Horizon Clinical Research Group - Cypress, Texas, United States
- Alina Clinical Trials, LLC. - Dallas, Texas, United States
- Greater Heights & Memorial Pulmonary and Sleep - Houston, Texas, United States
- Houston Pulmonary Sleep and Allergy Associates - Houston, Texas, United States
- Metroplex Pulmonary and Sleep Center - McKinney, Texas, United States
- Clinical Research Partners, LLC - Richmond, Virginia, United States
- Bradford Royal Infirmary - Bradford, United Kingdom
- Centro de Investigaciones Metabólicas (CINME) - Buenos Aires, Argentina
- North Manchester General Hospital - Crumpsall, United Kingdom
- Fukuoka National Hospital - Fukuoka, Japan
- Medical Center Pulmo - 2018 EOOD - Haskovo, Bulgaria
- Hiroshima Prefectural Hospital - Hiroshima, Japan
- Fakultni nemocnice Hradec Kralove - Hradec Králové, Czechia
- Kaohsiung Medical University Chung-Ho Memorial Hospital - Kaohsiung City, Taiwan
- Centre Hospitalier Régional de la Citadelle - Liège, Belgium
- CEFISPIRO s.r.o. - Lovosice, Czechia
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Fundacion Scherbovsky - Mendoza, Argentina
- Instituto de Salud Respiratoria - Mendoza, Argentina
- Da Vinci Magánklinika - Pécs, Hungary
- Medical Center Pulmovision - Sofia, Bulgaria
- Medical Center New Rehabilitation Center EOOD - Stara Zagora, Bulgaria
- Taichung Veterans General Hospital - Taichung, Taiwan
- National Taiwan University Hospital - Taipei, Taiwan
- Chang Gung Medical Foundation-Linkou Branch - Taoyuan, Taiwan
- Azienda Ospedaliera Ordine Mauriziano di Torino - Torino, Italy
- Pinderfields General Hospital - Wakefield, United Kingdom
- AZ Sint-Maarten - Mechelen, Antwerpen, Belgium
- Beijing Chao-Yang Hospital, Capital Medical University - Beijing, Beijing Municipality, China
- China-Japan Friendship Hospital - Beijing, Beijing Municipality, China
Showing 60 of 132 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →