Dupilumab Safety in Children with Chronic Spontaneous Urticaria
This study aims to evaluate the safety and effectiveness of Dupilumab treatment in children with chronic spontaneous urticaria by measuring its concentration in the blood at weeks 12 and 24.
Dupilumab
Chronic Urticaria+9
+ Chronic Disease
+ Hypersensitivity
Treatment Study
Summary
Study start date: August 25, 2022
Actual date on which the first participant was enrolled.This study focuses on understanding how the drug dupilumab works in the bodies of children between the ages of 2 and 12 who have a condition called chronic spontaneous urticaria (CSU) that isn't getting better with standard allergy medications. CSU causes uncomfortable and persistent hives or welts on the skin. The main goal is to examine how the drug is processed in the body (known as pharmacokinetics) and to ensure it is safe for use in this young age group. Finding effective treatment options for children who suffer from such persistent symptoms is important for improving their quality of life. Participants in this study are treated with dupilumab over a 24-week period. The drug is administered, and blood samples are taken at specific times to measure the concentration of the drug in the body, particularly at the 12th and 24th weeks. This helps researchers understand how the drug behaves over time. The study includes a screening period of up to 4 weeks, followed by 6 visits over the course of the study. There is also a 12-week follow-up after treatment ends to monitor any long-term effects. This structured approach ensures a thorough evaluation of the drug's safety and how well it works in managing CSU symptoms.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.15 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 2 to 11 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 15 locations
Pediatric Dermatology of Miami Site Number : 8400015
Coral Gables, United StatesOpen Pediatric Dermatology of Miami Site Number : 8400015 in Google MapsTreasure Valley Medical Research Site Number : 8400019
Boise, United StatesWashington University School of Medicine- Site Number : 8400004
St Louis, United StatesBoston Childrens Health Physicians Site Number : 8400017
Hawthorne, United States