NL-OMON52375招募中3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 99（—）
入选标准
- •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
- •H1-antihistamine
- •* UAS7 score (range 0-42) >= 16 and HSS7 (range 0-21) >= 8 during the 7 days
- •prior to randomization (Visit 110, Day 1)
- •* Subjects must be on H1-antihistamine at only locally label approved doses for
- •treatment of CSU starting at Visit 1 (Day -28 to Day -14)
- •* Willing and able to complete a daily symptom eDiary for the duration of the
- •study and adhere to the study visit schedules.
- •* Other protocol-defined inclusion criteria may apply
排除标准
- •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,
- •due to C1 inhibitor deficiency).
- •* Subjects with evidence of helminthic parasitic infection as evidenced by
- •stools being positive for a pathogenic organism according to local guidelines.
- •All subjects will be screened at Visit 1. If stool testing is positive for
- •pathogenic organism, the subject will not be randomized and will not be allowed
- •to rescreen.
- •* Any other skin disease associated with chronic itching that might influence
- •in the investigators opinion the study evaluations and results (e.g. atopic
- •dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus,
- •* Prior exposure to ligelizumab, omalizumab and other IgE therapies.
- •* Any H2 antihistamine, LTRA (montelukast or zafirlukast) or H1-AH used as
- •background medication at greater than local label approved doses after Visit 1.
- •* Other protocol-defined exclusion criteria may apply
研究者
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