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Itepekimab for COPD (AERIFY-1 Trial)
AERIFY-1 Trial Summary
This trial is testing a new medication, itepekimab, to see if it is effective in treating COPD in former smokers. The study will also look at the safety and tolerability of the medication.
AERIFY-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAERIFY-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AERIFY-1 Trial Design
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Who is running the clinical trial?
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- I have had severe breathing issues that needed steroids or antibiotics.I've been on a stable asthma treatment for at least 3 months.I have asthma or had it before I turned 18.I have previously used itepekimab.This information may not include all the factors that need to be considered before deciding whether to participate in a clinical trial.I am between 40 and 85 years old.I have been diagnosed with COPD for at least a year.I need a BiPAP machine due to high carbon dioxide levels in my blood.I have had a chronic cough for at least 3 months in the past year, and it's not due to other known causes.I have irregular heartbeats, including occasional atrial fibrillation.I have an active autoimmune disease or am on immunosuppressive therapy for one.I have had at least one worsening of my breathing problem while on my current medication.I have not smoked or vaped anything in the last 6 months.I've had 2 or more moderate or 1 severe flare-up in the last year, treated with steroids.I have had a chronic cough for at least 3 months in the past year, and it's not due to other known causes.I am not pregnant or breastfeeding and either cannot become pregnant or will follow birth control guidelines.I have moderate-to-severe chronic obstructive pulmonary disease.I smoked for 10 or more years but quit at least 6 months ago and don't plan to start again.I have moderate-to-severe chronic obstructive pulmonary disease.I smoked for 10 or more years but quit at least 6 months ago and don't plan to start again.I am between 40 and 85 years old.I have been diagnosed with COPD for at least a year.
- Group 1: Itepekimab Q2W
- Group 2: Itepekimab Q4W
- Group 3: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Could I possibly participate in this test if I qualify?
"This trial is looking for 930 patients that have obstructive lung disease and are between 40-85 years old. To meet the criteria for this study, participants must have moderate exacerbations, be diagnosed with COPD by a physician, have a smoking history of 10 pack years, not currently be smoking, and quit smoking 6 months prior to screening. Additionally, participants must have standard care controller therapy 3 months prior to screening at a stable dose for 1 month prior to screening. This includes inhaled corticosteroid (ICS) + long-acting beta-agonist (LABA), long-acting muscarinic antagonist (LAMA"
Could people who are 50 or older still participate in this research project?
"This clinical trial only enrolls patients aged 40 to 85. If you are looking for a similar study but outside of this age range, there are 480 trials for patients over 65 and 36 for those under 18."
Are there many hospitals doing this research in America?
"This trial has 80 different sites across the States, for example Clinrx Research-Site Number:8400021 in Carrollton, Clearlake Specialties-Site Number:8400025 in Webster, and Texas Tech University Health Sciences Center-Site Number: 8400189."
Are enrolling any more patients in this clinical trial?
"From what is indicated on clinicaltrials.gov, this trial is still looking for patients to participate and has been since December 16th, 2020. The last update to the posting was on October 26th, 2022."
Is Itepekimab SAR440340 dangerous to human beings?
"Itepekimab SAR440340 is estimated to be a safe medication because it has reached Phase 3 in clinical trials. This means that not only does the drug show some efficacy, but there is also multiple rounds of data supporting its safety."
Could you please provide a list of all previous investigation involving Itepekimab SAR440340?
"Istekimab SAR440340 was first studied in 2020 at site number 8040004. There have been a total of 18279 completed studies as of now. Currently, there are two ongoing studies recruiting participants, with many of these taking place in Carrollton, Texas."
Is this research project unique or have similar projects been undertaken in the past?
"There are 2 ongoing Itepekimab SAR440340 studies being conducted in 32 countries and 152 cities. The first study was completed in 2020 by Sanofi. That particular research project reached Phase 3 drug approval and involved 930 patients. To date, 18279 similar studies have been carried out since the year 2020."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What site did they apply to?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Average response time
- < 2 Days
Most responsive sites:
- GenHarp Clinical Solutions-Site Number:8400028: < 48 hours
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