New hope for kids with stubborn hives: dupixent studied
NCT ID NCT05526521
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested the drug dupilumab (Dupixent) in 15 children aged 2 to 12 who have chronic spontaneous urticaria (CSU), also known as long-lasting hives, that didn't get better with antihistamines. The main goals were to check how the drug behaves in the body and to see if it's safe. The children received injections for 24 weeks and were followed for 12 more weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dupilumab (Dupixent)
- What this could lead to
- If it works, this could offer a new treatment option for children with chronic hives that don't respond to standard antihistamines.
- What could go wrong
- This is a small, single-arm study with only 15 participants, so results may not apply to all children. It primarily looked at safety and drug levels, not how well it works.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
15 people
The number who actually took part.
- Started
-
Aug 2022
- Finished
-
Feb 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
2 to 11 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * Participant/parent(s)/caregiver(s)/participant's legally authorized representative, as appropriate, willing and able to comply with study visits and related procedures. Exclusion Criteria: Participants were excluded from the study if any of the following criteria apply: * 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. * Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. * Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated. * Diagnosed with, suspected of, or at high risk of endoparasitic infection. * Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the screening visit or during the screening period. * Known or suspected immunodeficiency. * Active malignancy or history of malignancy within 5 years before the baseline visit. * History of systemic hypersensitivity or anaphylaxis to dupilumab including any excipient. * Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic spontaneous urticaria are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Boston Childrens Health Physicians Site Number : 8400017
Hawthorne, New York, 10532, United States
-
Childrens Hospital Medical Center of Akron- Site Number : 8400020
Akron, Ohio, 44308, United States
-
Cincinnati Children's Hospital Medical Center - PIN- Site Number : 8400001
Cincinnati, Ohio, 45229-3026, United States
-
Columbia University Irving Medical Center Site Number : 8400003
New York, New York, 10032, United States
-
Investigational Site Number : 1240001
Montreal, Quebec, H4A 3J1, Canada
-
Investigational Site Number : 1240007
Hamilton, Ontario, L8S1G5, Canada
-
Investigational Site Number : 1240009
Calgary, Alberta, T2W 4X9, Canada
-
Investigational Site Number : 1240010
Edmonton, Alberta, T5J 3S9, Canada
-
Investigational Site Number : 3920001
Yokohama, Kanagawa, 232-8555, Japan
-
Investigational Site Number : 3920002
Tsu, Mie-ken, 514-0125, Japan
-
Monroe Carell Jr. Childrens Hospital at Vanderbilt- Site Number : 8400005
Nashville, Tennessee, 37232, United States
-
Pediatric Dermatology of Miami Site Number : 8400015
Coral Gables, Florida, 33146, United States
-
Treasure Valley Medical Research Site Number : 8400019
Boise, Idaho, 83706, United States
-
Vital Prospects Clinical Research Institute, P.C.- Site Number : 8400002
Tulsa, Oklahoma, 74136, United States
-
Washington University School of Medicine- Site Number : 8400004
St Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.