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Dupilumab for Childhood Asthma
Study Summary
This trial is looking at the long-term safety and efficacy of dupilumab in children with asthma. They will also be looking at the exposure to the drug, any adverse reactions, and any biomarkers associated with the drug.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am a child aged 6-11 with asthma diagnosed by a doctor for over a year.You had a bad reaction to dupilumab in the past, and your doctor thinks it's not safe for you to take it again.People from Brazil who stopped taking the study medication early to get the Yellow Fever vaccine during a Yellow Fever outbreak can join the study after finishing all the required procedures from the previous study.I have a chronic lung condition other than asthma.My child has asthma and finished a dupilumab trial.You have an untreated parasitic infection or are at high risk for getting one, unless the doctor has confirmed that you don't have an active infection.I have an active autoimmune disease or am on immunosuppressive therapy for one.I have been treated with dupilumab in Japan.I am not on any treatments that are not allowed in the study.In the Japan sub-study, you have a high level of blood eosinophils or fractional exhaled nitric oxide during the screening visit.I am a menstruating woman not using birth control or might be pregnant.I plan to get live vaccines during the study.You have a history of weakened immune system or frequent, serious infections, even if they have been treated.
- Group 1: Dupilumab
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 study have an age limit?
"The age range that is able to enroll in this study starts at 6 years old and ends when the patient reaches 11 years old."
Are there vacancies in this research program for new test subjects?
"This particular clinical trial is not enrolling new patients, as reflected on the clinicaltrials.gov website. The listing was first posted on June 21st, 2018 and updated for the last time on October 4th, 2022; however, there are 778 other trials that are still recruiting patients."
How many different medical facilities are overseeing this clinical trial?
"At the moment, there are 26 sites where patients can enroll in this study. They are situated in cities like Cincinnati, Rochester and Great Neck as well as 23 other places. To lessen travel demands for participants, it is best to select a location nearby."
Are there FDA-approved treatments for asthma?
"Asthma reliever therapies have been through multiple rounds of testing and have shown efficacy in some cases, so they receive a score of 3."
How many people are being given the chance to participate in this experiment?
"This particular trial is no longer enrolling patients. The study was initially posted on June 21st, 2018 but the last update occurred on October 4th, 2022. There are currently 326 other trials related to asthma and 452 clinical trials regarding asthma reliever therapies that are actively looking for participants."
How does Asthma reliever therapy differ from other treatments?
"Asthma reliever therapies are most commonly used to treat dermatitis and atopic. However, it can also be used to manage other conditions such as multiple sclerosis, ulcerative colitis, varicella-zoster virus acute retinal necrosis."
Who meets the requirements to join this clinical trial?
"This trial is enrolling 365 children aged 6-11 who have asthma. In addition to meeting the age requirement, participants must also have been diagnosed with persistent asthma by a physician for at least 12 months prior to screening. For Japan sub-study only."
What are the main goals of this experiment?
"The pharmaceutical company Sanofi, who is sponsoring this study, has outlined the primary outcome measure. Over the course of 12 weeks, they will be measuring The number of patients experiencing any treatment emergent adverse event (TEAE). Additionally, this trial will also collect data on Japan sub-study: Change from baseline in FVC which is defined as Change from baseline in FVC., Japan sub-study: Change from baseline in FEF 25-75% which is defined as Change from baseline in FEF 25-75%., and Japan sub-study: The number of patients experiencing any TEAEs which is defined as The number of"
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