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New treatment option for Asthma
Official title A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
ClinicalTrials.gov ID: NCT06977581
What this study is testing
What is PF-07275315?
PF-07275315 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for asthma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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...
- Positive bronchodilator responsiveness as evidenced by increase in FEV1 of at least 12% and 200 mL for spirometry conducted during screening period.
You likely can't join if
- Medical Conditions:
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may...
- Evidence of lung disease(s) other than asthma, either clinical evidence, spirometry, or imaging (Chest X-ray, CT, MRI) within 12 months of the...
- 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;
See the full eligibility 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...
- ACQ-5 score of ≥1.5 at screening visit and prior to randomization. Other
- Body mass index between 18 40 kg/m2 at screening.
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Chandler, Arizona, United States
- Lancaster, California, United States
- Newport Beach, California, United States
- Northridge, California, United States
- San Jose, California, United States
- Walnut Creek, California, United States
- Colorado Springs, Colorado, United States
- East Point, Georgia, United States
- Champaign, Illinois, United States
- Kansas City, Kansas, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Henderson, Nevada, United States
- New Brunswick, New Jersey, United States
- Riverdale, New Jersey, United States
- Charlotte, North Carolina, United States
- Gastonia, North Carolina, United States
- Huntersville, North Carolina, United States
- Toledo, Ohio, United States
+ 91 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; Chandler, Arizona, United States; Lancaster, California, United States; Newport Beach, California, United States; Northridge, California, United States; San Jose, California, United States and 105 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.