A multi-center, randomized, double-blind, active and placebo-controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Spontaneous Urticaria (CSU) in adolescents and adults inadequately controlled with H1-antihistamines - CQGE031C2303

ovartis0 个研究点目标入组 32 人待定

概览

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注册库

who.int

开始日期

待定

结束日期

待定

最后更新

2年前

研究类型

Interventional

发起方

•Signed informed consent must be obtained prior to participation in the study.
•The subject's, parent's or legal guardian's signed written informed consent and
•child's assent, if appropriate, must be obtained before any assessment is
•performed., \* Male and female subjects \>\= 12 years of age at the time of
•\* CSU diagnosis for \>\= 6 months (defined as onset of CSU with supporting
•documentation).
•\* Diagnosis of CSU refractory to H1\-AH at locally label approved doses at the
•time of randomization, as defined by all of the following:
•\* The presence of itch and hives for \>\= 6 consecutive weeks at any time prior to
•Visit 1 (Day \- 28 to Day \-14\) despite current use of non\-sedating

•History of hypersensitivity to any of the study drugs or their excipients or to
•drugs of similar chemical classes (i.e. to murine, chimeric or human
•antibodies).
•\* Subjects having a clearly defined cause of their chronic urticaria, other
•than CSU. This includes, but is not limited to, the following: symptomatic
•dermographism (urticaria factitia), cold\-, heat\-, solar\-, pressure\-, delayed
•pressure\-, aquagenic\-, cholinergicor contact\-urticaria.
•\* Diseases, other than chronic urticaria, with urticarial or angioedema
•symptoms such as urticarial vasculitis, erythema multiforme, cutaneous
•mastocytosis (urticaria pigmentosa) and hereditary or acquired angioedema (eg,

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