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Itepekimab for COPD (AERIFY-3 Trial)
AERIFY-3 Trial Summary
This trialtests how a new drug, Itepekimab, affects airway inflammation in smokers with COPD. Participants will stay on their current COPD treatments while being monitored over 36 weeks.
AERIFY-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAERIFY-3 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AERIFY-3 Trial Design
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Who is running the clinical trial?
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- I need more than 2 liters per minute of oxygen for daily use.If you used to smoke, you cannot have smoked or vaped anything in the last 6 months.I have had a serious COPD flare-up in the last 8 weeks.I have had cancer within the last 5 years.I quit smoking more than 6 months ago and don't plan to start again.I have no surgeries or major procedures planned during the study.My heart condition is not stable.I have HIV or tested positive for HIV.I have had surgery or a procedure on my lung before.You have smoked an average of one pack of cigarettes a day for at least 10 years.I have had shingles symptoms within the last 3 months.You are regularly around other people who smoke indoors (former smokers only).I am currently on medication for a serious infection.I suspect or have been confirmed to have COVID-19, or I've been in contact with someone who has it.If you are a current smoker, you cannot participate in the study if you are not currently in a program to quit smoking or do not plan to start one during the screening period.I've had a severe asthma attack treated with steroids in the last 5 years.I have been vaccinated against COVID-19 at least a week before my screening.I have an active autoimmune disease or am on immunosuppressive therapy for it.You need to have a body mass index (BMI) of at least 18 kg/m2.I have been diagnosed with COPD for at least a year.I am not pregnant or breastfeeding and either cannot become pregnant or agree to use birth control.I need a BiPAP machine due to high carbon dioxide levels in my blood.I have symptoms like coughing and mucus that suggest I have chronic bronchitis.I have or am at high risk for tuberculosis.I have been on a stable dose of my standard asthma treatment for at least 4 months.I need medication to prevent heart infection due to my condition.I have been diagnosed with asthma following GINA guidelines, or it resolved before I turned 18.I have irregular heartbeats, including occasional atrial fibrillation.I have previously used Itepekimab.If you smoke or use e-cigarettes, you cannot have done so in the past 6 months or during the screening period.My high blood pressure is not under control.I have been diagnosed with heart issues related to lung blood pressure.I am between 40 and 70 years old.I have a lung condition that is not COPD.I have severe heart failure or a serious heart condition.My recent ECG shows new significant issues.
- Group 1: Itepekimab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research include participants over the age of 40?
"According to the outlined parameters of this trial, individuals aged 40 and above but below 70 are eligible for enrollment."
Are there any vacancies remaining for participants in this clinical trial?
"Indeed, the information on clinicaltrials.gov states that recruitment for this trial is in progress. It was posted initially on May 19th 2022 and most recently updated January 17th 2023. The study requires 60 patients to be enrolled from two sites."
What impact has Itepekimab been found to have on patients' well-being?
"Our risk assessment of itepekimab's safety is moderate, rating a 2 out of 3. This drug has passed through stage two clinical trials, demonstrating some proof-of-concept regarding its security; however, there is no definitive evidence on the efficacy yet."
Who would be an ideal candidate for this medical experiment?
"This medical trial is seeking 60 participants from the age range of 40-70 with a confirmed diagnosis of chronic obstructive pulmonary disease (COPD). To be eligible for enrolment, volunteers must have smoked for at least 10 pack-years and their COPD symptoms should have been present in the year preceding screening. Additionally, they must not currently be smoking or planning to start any smoking cessation interventions before or during the screening period. Furthermore, those partaking must meet other criteria such as having experienced moderate exacerbations requiring systemic corticosteroids/antibiotics and receiving stable doses of controller therapy among others. Finally, it is obligatory that"
What goals are you attempting to accomplish with this research?
"This trial, which will be tracked from the outset to Week 12, has one primary goal: a logarithmic shift in gene expression as observed through endobronchial biopsies. Secondary objectives include an alteration of interleukin-33 affected eosinophil and mast cell derived NESs when tested on former smokers with COPD; likewise, changes must also be monitored in preclinical mouse models-derived neutrophilic extracellular traps (NESs) amongst this cohort."
How many individuals are taking part in the clinical trial?
"Affirmative, the clinical trial is presently open for enrollment. As per the info posted on clinicaltrials.gov, this study was first available on May 19th 2022 and last edited on January 17th 2023. The researchers need 60 participants from two locations."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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