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

Investigation of an investigational medication for children with chronic spontaneous urticaria (CSU)

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

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 04 Apr 2025. Study ID: NCT05526521

This study investigates the pharmacokinetics (PK) and safety of an investigational medication in children with chronic spontaneous urticaria (CSU). CSU is a condition where children experience itchy hives that come and go without a known cause. This study aims to understand how the investigational medication is processed in the body and to evaluate its safety in children who continue to have symptoms despite using H1-antihistamines.

Participants will undergo various study procedures, including a screening period that lasts 2 to 4 weeks. The treatment phase will last for 24 weeks, followed by a 12-week follow-up period. Throughout the study, participants will have a total of 6 visits to monitor their health and the effects of the investigational medication.

  • Who can participate: Children aged 2 to less than 12 years who have been diagnosed with CSU or have symptoms consistent with CSU for at least 3 months can participate. Participants must weigh between 5 kg and less than 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 regular visits to monitor health and any effects of the medication. A placebo is not involved in this study.
  • Study Timelines and Visits: The study will last 38 to 40 weeks. The study requires 6 visits.