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New treatment option for Moderate to Severe Asthma
Official title Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
ClinicalTrials.gov ID: NCT06385236
What this study is testing
What is Dupilumab?
Dupilumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for moderate to severe asthma.
Also referred to as Dupixent.
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
- In this study, a new method will be used to evaluate response to 2 approved biologic therapies, and assess how well each patient responds to each asthma treatment. This study will measure the response to these treatments using genomic and biologic measurements obtained from participants biosamples.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
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 75
You may be able to join if
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Stable asthma medications: No change in asthma medications for the past 2 months:
- Use of medium or high dose inhaled corticosteroids (ICS) AND
- Use of an additional asthma controller medication.
- Baseline poor or uncontrolled asthma.
You likely can't join if
- Current participation in an treatment trial (e.g. drugs, diets, etc.).
- Currently on an asthma biologic or having been on biologic within 3 months of screening.
- Enrollment in a clinical trial where the study medication was administered within the past 60 days or within 5 half-lives (whichever is greater).
- Physician diagnosis of other chronic pulmonary disorders associated with asthma-like symptoms, including, but not limited to, cystic fibrosis (CF)...
- Receiving one or more immune-modulating therapies for diseases other than asthma. This includes biologics that are also approved for asthma.
- Receiving methotrexate, mycophenolate (CellCept®), or azathioprine (Imuran®).
See the full eligibility criteria
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Stable asthma medications: No change in asthma medications for the past 2 months:
- Use of medium or high dose inhaled corticosteroids (ICS) AND
- Use of an additional asthma controller medication.
- Baseline poor or uncontrolled asthma.
- Evidence of asthma demonstrated by either bronchodilator reversibility (either at screening or by historical evidence) or methacholine responsiveness (by historical evidence).
- Agreement to adhere to Lifestyle Considerations throughout study duration.
- Current participation in an treatment trial (e.g. drugs, diets, etc.).
- Currently on an asthma biologic or having been on biologic within 3 months of screening.
- Enrollment in a clinical trial where the study medication was administered within the past 60 days or within 5 half-lives (whichever is greater).
- Physician diagnosis of other chronic pulmonary disorders associated with asthma-like symptoms, including, but not limited to, cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), chronic bronchitis...
- Receiving one or more immune-modulating therapies for diseases other than asthma. This includes biologics that are also approved for asthma.
- Receiving methotrexate, mycophenolate (CellCept®), or azathioprine (Imuran®).
- Receiving aero allergen immunotherapy and not on at least 3 months of maintenance allergen immunotherapy.
- Underwent a bronchial thermoplasty within the last two years.
- Born before 30 weeks of gestation.
- Uncontrolled hypertension, defined as systolic blood pressure \> 160 mm/Hg or diastolic blood pressure \> 100 mm/Hg.
- History of malignancy except non-melanoma skin cancer within the last five years.
- History of smoking:
- If \<45 years old: Smoked for ≥5 pack-years\
- If ≥45 years old: Smoked ≥ 10 pack years.
- Active use of any inhalant \>1 time per month in the past year.
- Substance abuse within the last year.
- Unwillingness to practice medically acceptable birth control or complete abstinence during the study, current pregnancy, or lactation.
- Requirement for daily systemic corticosteroids at the time of screening.
- Respiratory infection within 1 month of screening.
- Intubation for asthma in the last 12 months.
- Any clinically significant abnormal findings in the history, physical examination, vital signs, electrocardiogram, hematology or clinical chemistry during run-in period, which in the opinion of the site investigator...
- BMI \> 38.
- Allergic to any of the drugs, biologics or chemicals used in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- La Jolla, California, United States
- New Haven, Connecticut, United States
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; La Jolla, California, United States; New Haven, Connecticut, United States. 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.