A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to

Study on How an Investigational Medication Works and Its Safety in Children with a Skin Condition

Not Recruiting
2 years - 11 years
All
Phase 3
15 participants needed

Study Overview

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.

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 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.

This study investigates the pharmacokinetics (how the body processes a drug) and safety of an investigational medication in children who have been diagnosed with chronic spontaneous urticaria (CSU). This study focuses on children who continue to experience symptoms despite taking H1-antihistamines.

Participants will undergo several procedures during the study, including regular monitoring of their health and response to the investigational medication. The study involves a screening period of 2 to 4 weeks, followed by a 24-week treatment phase, and concludes with a 12-week follow-up period. The study will include 6 visits to the research center.

  • Who can participate: Children aged 2 to under 12 years with a diagnosis of CSU and who remain symptomatic despite regular H1-antihistamine treatment are eligible. Participants must weigh between 5 kg and 60 kg and be able to comply with study visits and procedures.
  • Study details: Participants will receive the investigational medication and be monitored for safety and how the body processes the drug. They will attend scheduled visits for health assessments and to track the investigational medication's effects.
  • Study timelines and visits: The study will last 38 to 40 weeks. The study requires 6 visits.
Updated on 04 Dec 2025. Study ID: NCT05526521