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)

Investigating the Safety and Pharmacokinetics (how the body processes a drug) of an Investigational Medication in Children with Chronic Spontaneous Urticaria

Recruiting
2 years - 11 years
All
Phase 3
24 participants needed
8 Locations

Study Overview

This is a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study is 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 include: Screening: 2 to 4 weeks; The treatment duration will be 24 weeks; Follow-up period: 12 weeks; The study duration will be 38 to 40 weeks (including screening and follow-up); The number of study visits will be 6.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Spontaneous Urticaria
  • Age: 2 years - 11 years
  • Gender: All

Inclusion Criteria:

  • Participant must be ≥ 2 years to <12 years of age, at the time of signing the informed consent.
  • Participants who have 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 are 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 patient'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.

Updated on 07 Jun 2024. Study ID: NCT05526521

This study investigates the safety and pharmacokinetics (how the body processes a drug) of an investigational medication in children with Chronic Spontaneous Urticaria (CSU). CSU is a condition characterized by recurrent itchy hives with or without swelling, lasting more than 6 weeks, despite treatment with H1-antihistamines. The study aims to understand how the investigational medication works in children who continue to experience symptoms.

Participants in this study will receive the investigational medication over a 24-week period. The study procedures include screening, treatment, and follow-up phases. During these phases, participants will undergo various assessments to monitor their response to the medication and any side effects. The study includes six visits to the study center to ensure careful monitoring and data collection.

  • Who can participate: Children aged 2 to less than 12 years diagnosed with CSU or with symptoms consistent with CSU for at least 3 months may participate. Participants must weigh between 5 kg and 60 kg and continue to have symptoms despite regular H1-antihistamine treatment.
  • Study details: Participants will receive an investigational medication to assess its safety and how it is processed in the body. The study will involve six visits where participants will be monitored for any side effects and their response to the medication will be evaluated. A placebo is not used in this study.
  • Study Timelines and Visits: The study will last 38 to 40 weeks. The study requires 6 visits.

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