CTRI/2024/01/061601尚未招募3 期
A global, multicenter, randomized, double-blind, double-dummy, parallel-group, Phase 3b study to assess the efficacy, safety, and tolerability of remibrutinib 25 mg b.i.d. in comparison to placebo with omalizumab 300 mg every 4 weeks as active control over 52 weeks in adult patients with chronic spontaneous urticaria inadequately controlled by second-generation H1-antihistamines. - NI
ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •CSU duration for = 6 months prior to screening.
- •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.
- •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.
- •Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol.
- •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
- •Prior exposure to ligelizumab, omalizumab and other biologics with any effect in CSU, including anti-IgE therapies.
研究者
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