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This trial is a study to test the safety and effectiveness of a new medication for children with chronic hives who remain symptomatic despite other treatments. The study will last 38-40 weeks and there will be 8 study visits.
- Chronic Urticaria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2021 Phase 4 trial • 188 Patients • NCT04033367
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Who is running the clinical trial?
- You have a chronic skin condition that is not chronic spontaneous urticaria (CSU).You have skin conditions other than chronic spontaneous urticaria that could affect the study results.You have been diagnosed with a condition called chronic inducible cold urticaria.You have active Alzheimer's disease.You have an active tuberculosis (TB) infection or a history of not finishing treatment for TB.You have been diagnosed with, suspected of, or at high risk of having an internal parasite infection.You have had cancer or are currently being treated for cancer within the last 5 years.You have had a serious allergic reaction to dupilumab or any of its ingredients in the past.You have taken part in a previous study for dupilumab or have used dupilumab that is available in stores.You have been diagnosed with chronic spontaneous urticaria (CSU) or have been experiencing symptoms of CSU for at least 3 months, according to the doctor.You have hives that itch and swell for more than 6 weeks despite taking regular antihistamine medication.Your weight is between 5 and 60 kilograms.
- Group 1: Dupilumab
- 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
Has the FDA given Dupilumab the green light?
"Dupilumab has received a safety score of 3. This is due to the fact that it is a Phase 3 trial, which means that there is available data which supports its efficacy as well as its safety from multiple rounds of testing."
Are people being recruited for this research right now?
"Yes, the clinicaltrials.gov website shows that this trial is actively recruiting patients. The listing was first posted on August 25th, 2022 and updated on October 26th, 2022."
Does this research project allow individuals that are over the age of 50 to participate?
"Children aged 2 to 11 can participate in this clinical trial. There are 8 similar trials for younger patients and 34 for senior citizens."
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