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Dupilumab for Asthma (IDEA Trial)
IDEA Trial Summary
This trial will investigate if a certain gene variant will respond better to a 48 week therapy with dupilumab, in order to help manage asthma exacerbations.
IDEA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowIDEA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 4 trial • 188 Patients • NCT04033367IDEA Trial Design
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Who is running the clinical trial?
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- I am not currently on immunosuppressants for conditions other than asthma.You are currently smoking or quit smoking less than 6 months ago.You have used an electronic vaping device or quit using it less than 6 months before the screening.I haven't needed antibiotics or steroids for a lung problem in the last 4 weeks.I can do breathing tests.I am a woman who can have children and my pregnancy test is negative.I am on a stable allergen immunotherapy plan for at least 2 months.I am 12 years old or older.I have been diagnosed with asthma by a doctor.I agree to use approved birth control methods during the study.I've been on a stable, medium to high dose asthma medication for at least 3 months or used a biologic asthma medication in the last 8 weeks.I had a severe asthma attack in the last year.I have not received a live vaccine in the last 4 weeks.You have had problems with drinking too much alcohol or using illegal drugs in the last 6 months.Your blood test shows very low levels of white blood cells, platelets, or hemoglobin, or high levels of eosinophils.I have a long-term lung condition that is not asthma.
- Group 1: Treatment group
- Group 2: Placebo group
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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
Are there any vacancies for potential participants in this trial?
"Affirmative. Clinicaltrials.gov displays that this research project, which was originally unveiled on September 8th 2021 is still open to volunteers. It seeks to enrol 150 people across 7 separate medical facilities."
How many participants are currently taking part in this experiment?
"Correct. According to clinicaltrials.gov, this medical study is actively seeking participants that meet the criteria for inclusion. It was opened on September 8th 2021 and last updated on August 8th 2022; 150 subjects need to be enrolled at 7 distinct locations."
Does this experiment represent an unprecedented approach to treatment?
"To date, Dupilumab has been studied in 49 separate trials hosted over 436 cities and 43 countries. The first clinical trial occurred back in 2015, sponsored by Sanofi with 880 participants who completed Phase 3 regulatory review. Since then, 18360 additional studies have taken place."
What potential harm could be caused by using Dupilumab?
"The safety rating for Dupilumab is a 3, as this product has been approved following four phases of clinical trials."
What medical conditions is Dupilumab commonly utilized to treat?
"Dupilimab is the primary remedy for treating atopic dermatitis. It can also help people whose corticosteroid therapy has failed as well as those suffering from asthma and eosinophilic inflammation."
What have been some of the previous explorations into Dupilumab's effectiveness?
"At present, 49 clinical trials aim to evaluate the efficacy of Dupilumab. Of those studies 13 are in Phase 3. While many research sites for this treatment can be found near Palo Alto, CA; a total of 2602 locations throughout America provide access to these tests and treatments."
How many different sites are managing this research project?
"Participants for this medical study are being selected from MetroHealth System in Cleveland, Ohio; University of Pennsylvania in Philadelphia, Pennsylvania; Montefiore Einstein Clinical Research Center in Bronx, New york and 7 other sites."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
What questions have other patients asked about this trial?
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