Frontlight ResearchEarly access
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
- NCT05526521
- EudraCT 2022-000260-22
- U1111-1266-5669
- 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