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Dupilumab for Eczema
Study Summary
This trial is testing the long-term safety and efficacy of dupilumab, a medication used to treat eczema, in children. The trial will also assess the levels of functional dupilumab in the blood after repeated treatment and the immunogenicity of the medication.
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.Side effects data
From 2021 Phase 4 trial • 188 Patients • NCT04033367Trial Design
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- I haven't taken any experimental drugs recently, except for dupilumab.I have or am at high risk for serious worm infections.You have missed one or more of the last three planned injections in the main study before entering the sub-study.You have already taken part in a study for dupilumab in kids with AD and finished all the required visits and tests for that study.If you were in a previous study with Dupilumab and had a bad reaction to the drug that made you stop treatment, you may not be able to join this study.I had a serious side effect from dupilumab in a previous study.I switched my dupilumab dose in the last 12 weeks.I've been on the same dupilumab dose for the last 12 weeks as in the PFP study.I have used drugs that affect my immune system in the last 4 weeks.I have not received a live vaccine in the last 4 weeks.My weight is between 5 kg and 60 kg.I qualify for a drug discontinuation as per the study's rules.I am between 2 and 11 years old, for the PFP study.
- Group 1: Body weight 5 kg to <15 kg
- Group 2: Body weight ≥60 kg
- Group 3: Body weight 30 kg to <60 kg
- Group 4: Body weight 15 kg to <30 kg
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What are some of the most well-known health conditions that Dupilumab can help with?
"Dupilumab is often used as an immunotherapy treatment for atopic dermatitis. It can also help patients who have corticosteroid-resistant asthma, eosinophilic asthma, and chronic spontaneous urticaria."
Where can patients go to receive this treatment?
"Currently, this trial is being conducted in 47 different locations. Some of these places include Washington, Seattle and Philadelphia. There are also 47 other locations. When deciding on a clinic, please choose the one that is closest to your residence to minimize travel."
What prior research has been conducted using Dupilumab?
"Dupilumab was first trialled in 2015 by Regeneron. To date, there have been 54 completed clinical trials with 53 more currently underway. Many of these active studies are situated in Washington, D.C."
What are the US government's thoughts on Dupilumab?
"There is pre-existing evidence for Dupilumab's efficacy and safety from Phase 3 trials, resulting in a safety score of 3."
Does this clinical trial set a precedent?
"As of now, there are 53 ongoing clinical trials for Dupilumab in 455 different cities and 43 countries. The first trial happened in 2015 and was completed in the Phase 3 stage of drug approval. Sanofi sponsored the trial which had 880 patients. In the 5 years since the first trial, 54 studies have been completed."
Does this research allow for minors to participate?
"The recruitment process for this study requires that potential participants are above 6 months old and below 17 years of age."
Are new participants currently being accepted into this research project?
"This study has completed recruitment and is no longer actively seeking patients. The study was posted on October 15th, 2015 and was last updated on July 26th, 2022. If you are seeking other studies, there are currently 255 studies actively looking for participants with eczema and 53 studies for Dupilumab admitting patients."
Could you give me an estimate of how many individuals are included in this clinical trial?
"As of July 26th, 2022, this study is no longer recruiting patients. If you are interested in participating in a clinical trial, there are presently 255 trials actively looking for patients with eczema and 53 studies for Dupilumab that are actively searching for patients."
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