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) or chronic inducible cold urticaria (CICU)

Tanaka Tomoyuki0 个研究点目标入组 24 人开始时间: 2023年3月26日最近更新: 2023年10月17日

试验速览

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•Participant must be >= 2 years to < 12 years of age, at the time of signing the informed consent.
•- Participants who have a documented diagnosis of CSU or CICU >6 months prior to screening visit.
•- Participants with CSU (characterized by recurrent itchy wheals with or without angioedema for >6 consecutive weeks) who remain symptomatic at the time of screening despite regular H1-antihistamine treatment.
•- Participants with CICU (characterized by recurrent itchy wheals with or without angioedema due to cold for >6 weeks) who remain symptomatic at the time of screening despite the regular or as-needed use of H1-antihistamine or appropriate preventive measures.
•- Participants with CICU with a positive ice cube provocation test, presenting with a confluent hive/wheal on the exposed skin area, at the screening visit.
•- 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.

•Participants are excluded from the study if any of the following criteria apply:
•Medical conditions
•- Underlying etiology for chronic urticarias other than CSU/CICU.
•- Presence of skin morbidities other than CSU/CICU that may interfere with the assessment of the study outcomes.
•- Participants with a concurrent diagnosis of both CSU and CICU.
•- 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.

发起方

Tanaka Tomoyuki