CTRI/2022/02/040702已完成3 期
A multicenter, randomized, double-blind, placebo-controlled Phase 3 study ofremibrutinib (LOU064) to investigate the efficacy, safety and tolerability for52 weeks in adult chronic spontaneous urticaria patients inadequatelycontrolled by H1-antihistamines
Novartis Healthcare Pvt Ltd10 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2022年2月3日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 10
- 主要终点
- To demonstrate that remibrutinib (25 mg
研究概览
简要总结
A Phase 3 study of efficacy and safety of remibrutinib in the treatment of
chronic spontaneous urticaria in adults inadequately controlled by H1-
antihistamines
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Signed informed consent must be obtained prior to participation in the study.
- •ï‚· Male and female adult participants ≥18 years of age at the time of screening.
- •ï‚· CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation).
- •ï‚· Diagnosis of CSU inadequately controlled by second generation H1- antihistamines at the time of randomization defined as: ï‚· The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the use of second generation H1-antihistamines during this time period ï‚· UAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0-21) ≥ 6 during the 7 days prior to randomization (Day 1) ï‚· Documentation of hives within three months before randomization (either at screening and/or at randomization; or documented in the participants medical history).
- •ï‚· Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol.
- •ï‚· Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1).
排除标准
- •1.Participants having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria ï‚· 2.Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or drug-induced urticaria ï‚· 3.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 or psoriasis 4.Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, New York heart association (NYHA) Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 12 months prior to Visit 1),neurological, psychiatric, pulmonary, renal, hepatic, endocrine,metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigators opinion, would compromise the safety of the participant,interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant ï‚· 5.Significant bleeding risk or coagulation disorders ï‚·
- •History of gastrointestinal bleeding, e.g. in association with use of nonsteroidal anti-inflammatory drugs (NSAID), that was clinically relevant (e.g. requiring hospitalization or blood transfusion) ï‚·
- •Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel.
- •The use of dual anti-platelet therapy (e.g. acetylsalicylic acid + clopidogrel) is prohibited.
- •Requirement for anticoagulant medication (for example, warfarin or Novel Oral Anti-Coagulants (NOAC)) ï‚·
- •History or current hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at screening.
结局指标
主要结局
To demonstrate that remibrutinib (25 mg
时间窗: To demonstrate that remibrutinib (25 mg | b.i.d.) is superior to placebo in CSU with | respect to change from baseline in UAS7 | at Week 12
b.i.d.) is superior to placebo in CSU with
时间窗: To demonstrate that remibrutinib (25 mg | b.i.d.) is superior to placebo in CSU with | respect to change from baseline in UAS7 | at Week 12
respect to change from baseline in UAS7
时间窗: To demonstrate that remibrutinib (25 mg | b.i.d.) is superior to placebo in CSU with | respect to change from baseline in UAS7 | at Week 12
at Week 12
时间窗: To demonstrate that remibrutinib (25 mg | b.i.d.) is superior to placebo in CSU with | respect to change from baseline in UAS7 | at Week 12
次要结局
- To demonstrate that a greater proportion(of participants who are treated with)
- To demonstrate the superiority of(remibrutinib (25 mg b.i.d.) treated)
- To demonstrate that remibrutinib (25 mg(b.i.d.) treated participants have more)
- To demonstrate the safety and tolerability(of remibrutinib (25 mg b.i.d.))
研究者
研究点 (10)
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