A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids)

Completed · Phase 3

Conditions studied: Chronic Spontaneous Urticaria

In brief

This was a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study was to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of H1-antihistamine treatment. Study details included: Screening: 2 to 4 weeks; The treatment duration was 24 weeks; Follow-up period: 12 weeks; The study duration was 38 to 40 weeks (including screening and follow-up); The number of study visits was 6.

Key facts

Study ID: NCT05526521
Run by: Sanofi
People needed: 15
Starts: 2022-08-25
Expected to finish: 2025-02-03
Last updated by the study team: 2025-11-25

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Pediatric Dermatology of Miami Site Number : 8400015 — Coral Gables, Florida, United States
Treasure Valley Medical Research Site Number : 8400019 — Boise, Idaho, United States
Washington University School of Medicine- Site Number : 8400004 — St Louis, Missouri, United States
Boston Childrens Health Physicians Site Number : 8400017 — Hawthorne, New York, United States
Columbia University Irving Medical Center Site Number : 8400003 — New York, New York, United States
Childrens Hospital Medical Center of Akron- Site Number : 8400020 — Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center - PIN- Site Number : 8400001 — Cincinnati, Ohio, United States
Vital Prospects Clinical Research Institute, P.C.- Site Number : 8400002 — Tulsa, Oklahoma, United States
Monroe Carell Jr. Childrens Hospital at Vanderbilt- Site Number : 8400005 — Nashville, Tennessee, United States
Investigational Site Number : 1240009 — Calgary, Alberta, Canada
Investigational Site Number : 1240010 — Edmonton, Alberta, Canada
Investigational Site Number : 1240007 — Hamilton, Ontario, Canada
Investigational Site Number : 1240001 — Montreal, Quebec, Canada
Investigational Site Number : 3920001 — Yokohama, Kanagawa, Japan
Investigational Site Number : 3920002 — Tsu, Mie-ken, Japan

Full record on ClinicalTrials.gov

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