Completed

Dupilumab Safety in Children with Chronic Spontaneous Urticaria

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Study Aim

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.

What is being tested

Dupilumab

Drug
Who is being recruted

Chronic Urticaria+9

+ Chronic Disease

+ Hypersensitivity

From 2 to 11 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 2022
See protocol details

Summary

Principal SponsorSanofi
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleA Multi-center, Single-arm Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Male and Female Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU)
NCT05526521
Principal SponsorSanofi
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Chronic UrticariaChronic DiseaseHypersensitivityHypersensitivity, ImmediateImmune System DiseasesPathologic ProcessesSkin DiseasesPathological Conditions, Signs and SymptomsUrticariaSkin and Connective Tissue DiseasesSkin Diseases, VascularDisease Attributes

Criteria

5 inclusion criteria required to participate
Participant must be ≥ 2 years to <12 years of age, at the time of signing the informed consent.

Participants who had history of a diagnosis of CSU prior to screening (Visit 1) or symptoms consistent with a diagnosis of CSU for at least 3 months in the Investigator's opinion.

Participants with CSU (characterized by recurrent itchy wheals with or without angioedema for >6 weeks) who remain symptomatic at the time of screening despite regular H1-antihistamine treatment.

Body weight within ≥5 kg to <60 kg.

Show More Criteria

12 exclusion criteria prevent from participating
Underlying etiology for chronic urticarias other than CSU.

Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes.

Participants with a diagnosis of chronic inducible cold urticaria.

Participants with active AD.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Administered subcutaneously (SC) every 4 weeks (Q4W) or every 2 weeks (Q2W) with or without an initial loading dose based on weight and age

Study 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

Suspended

Pediatric Dermatology of Miami Site Number : 8400015

Coral Gables, United StatesOpen Pediatric Dermatology of Miami Site Number : 8400015 in Google Maps
Suspended

Treasure Valley Medical Research Site Number : 8400019

Boise, United States
Suspended

Washington University School of Medicine- Site Number : 8400004

St Louis, United States
Suspended

Boston Childrens Health Physicians Site Number : 8400017

Hawthorne, United States
Completed15 Study Centers