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)

PKM16982

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.

2022-08-25

2025-03-01

2025-07-07

Recruiting

Early phase I

24

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

2024-03-12