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)

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

Aperçu de l'étude

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.

Critère d'éligibilité

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

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