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 - Pearl 1

ovartis Pharma AG0 个研究点目标入组 1,050 人2018年7月31日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: ovartis Pharma AG
入组人数: 1050
状态: 进行中（未招募）
最后更新: 4年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2018年7月31日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

ovartis Pharma AG

入排标准

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 screening.
•? 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
•Are the trial subjects under 18? yes

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 investigator's opinion the study evaluations and results
•(e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.).
•? Prior exposure to ligelizumab, omalizumab and other IgE therapies
•? Any H2 antihistamine, LTRA (montelukast or zafirlukast) or H1 antihistamines use at greater than approved doses after Visit 1\.
•? Other protocol\-defined exclusion criteria may apply