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CompletedPhase 3

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)

Key facts

Who runs it
Sanofi
Where
Akron, Boise, Cincinnati, Coral Gables, Hawthorne, Nashville, New York, St Louis, and Tulsa, United StatesSee the 9 sitesAlso in 2 other countries, 6 sites
Trial code
Status
Completed
Phase
Phase 3
People taking part
15 people enrolled
Started
25 Aug 2022
Ended
3 Feb 2025
Type of study
Interventional
Treatments tested
  • Dupilumab
Record updated
25 November 2025

Who can take part

Age
2 years to 11 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study
  • 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
  • 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
  • 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 malignancy or history of malignancy within 5 years before the baseline visit
  • History of systemic hypersensitivity or anaphylaxis to dupilumab including any excipient
  • 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
  • Known or suspected immunodeficiency

Where in United States

Also in 2 other countries, 6 sites

  • Childrens Hospital Medical Center of Akron- Site Number : 8400020Akron, United States
  • Treasure Valley Medical Research Site Number : 8400019Boise, United States
  • Cincinnati Children's Hospital Medical Center - PIN- Site Number : 8400001Cincinnati, United States
  • Pediatric Dermatology of Miami Site Number : 8400015Coral Gables, United States
  • Boston Childrens Health Physicians Site Number : 8400017Hawthorne, United States
  • Monroe Carell Jr. Childrens Hospital at Vanderbilt- Site Number : 8400005Nashville, United States
  • Columbia University Irving Medical Center- Site Number : 8400003New York, United States
  • Washington University School of Medicine- Site Number : 8400004St Louis, United States
  • Vital Prospects Clinical Research Institute, P.C.- Site Number : 8400002Tulsa, United States

About the trial

What the trial wants to find out

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.

The group in the trial

  • DupilumabTreatment being tested

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

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A 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)
Record updated
25 November 2025