2022-502159-78-00招募中3 期
A double-blind, randomized, placebo-controlled trial to evaluate the efficacy, pharmacokinetics and safety of remibrutinib (LOU064) for 24 weeks in adolescents from 12 to less than 18 years of age with chronic spontaneous urticaria inadequately controlled by H1-antihistamines followed by an optional open-label extension for up to another 3 years and an optional safety long-term treatment-free follow-up period for up to an additional 3 years.
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 20
- 主要终点
- Absolute change from baseline in ISS7, HSS7, UAS7 at week 12
研究概览
简要总结
To assess the efficacy of remibrutinib versus placebo in CSU with respect to absolute change from baseline in UAS7, ISS7 and HSS7 at Week 12
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Male and female adolescent participants aged ≥ 12 to < 18 years of age at the time of signing the informed consent.
- •CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation)
- •Diagnosis of CSU inadequately controlled by second-generation H1-AH at the time of randomization defined as: - The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of second-generation H1-AH during this time period according to local treatment guidelines - 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)
- •Documentation of hives within three months before randomization (either at screening and/or at randomization; or documented in the participants’ medical history)
排除标准
- •Previous use of remibrutinib or other BTK inhibitors
- •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
- •Significant bleeding risk or coagulation disorders.
- •History of gastrointestinal bleeding.
- •Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.
- •History or current hepatic disease.
- •Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's 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.
- •History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes
- •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
- •Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary angioedema, or drug-induced urticaria
结局指标
主要结局
Absolute change from baseline in ISS7, HSS7, UAS7 at week 12
Absolute change from baseline in ISS7, HSS7, UAS7 at week 12
次要结局
- Concentration of remibrutinib at Week 12 including Cmax, Tmax and AUC
- Absolute change from baseline in UAS7 at Week 12
- Achievement of UAS7 ≤ 6 (yes/no) at Week 12 and over time
- Achievement of UAS7 = 0 (yes/no) at Week 12 and over time
- Absolute change from baseline in CDLQI score at Week 12
- Number of weeks without angioedema, assessed by the cumulative number of weeks with an AAS7 = 0 response between baseline and Week 12
- Occurrence of treatment emergent AEs, SAEs and laboratory and vital signs abnormalities during the core period
- Occurrence of treatment-emergent adverse events, serious adverse events and laboratory and vital signs abnormalities during the OLE period
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (20)
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