CTRI/2025/01/079061招募中3 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU2)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 915
- 试验地点
- 15
- 主要终点
- Evaluate the clinical effect of barzolvolimab, compared to placebo, in reducing urticaria
研究概览
简要总结
This is a phase 3, randomized, double-blind, placebo-controlled, parallel group study
evaluating the efficacy and safety profile of 2 dose regimens of barzolvolimab in patients with
CSU who remain symptomatic despite treatment with H1AH. There is a Screening Phase that
lasts 2 to 4 weeks, a 24-week Placebo-controlled Treatment Phase, a 28-week Active
Treatment Phase, and a 16-week Follow-up Phase. Participants randomized to placebo for the
Placebo-controlled Treatment Phase will undergo a re-randomization at Week 24 to determine
treatment assignment during the Active Treatment Phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Read, understood, and provided written informed consent, and Health Insurance Portability and Accountability Act (HIPAA) authorization if applicable, after the nature of the study has been fully explained.
- •Participants must be able to provide informed consent themselves.
- •Male or female, greater than or equal to 18 years of age at the time of signing the informed consent.
- •Diagnosis of CSU greater than or equal to 6 months prior to Screening.
- •CSU refractory to a stable dose and regimen containing a second-generation H1AH as defined by all of the following: Recurrent pruritic wheals with or without angioedema for greater than or equal to 6 weeks at any time prior to Screening (Visit 1) despite treatment with a H1AH (hives consistent with CSU should be documented and confirmed by the investigator prior to randomization) Participants must have been on a stable dose and regimen containing a second generation H1 antihistamine (H1AH) at approved or increased (up to 4x approved) dose as background therapy for the treatment of CSU for greater than or equal to 4 weeks prior to randomization and which is expected to remain stable throughout the study.
- •UAS7 (range: 0 to 42) greater than or equal to 16 and ISS7 (range: 0 to 21) greater than or equal to 8 during the 7-day period (Day -7 to Day -1) immediately prior to randomization.
- •Willing and able to comply with all study requirements and procedures, including the completion of a daily symptom diary during screening and throughout the study.
排除标准
- •Diseases with possible symptoms of urticaria or angioedema such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), autoimmune syndromes with urticarial lesions (e.g., Schnitzler Syndrome) and hereditary or acquired angioedema (e.g., due to C1 inhibitor deficiency).
- •Active chronic inducible urticaria (CIndU) including symptomatic dermographism (urticaria factitia), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact urticaria that would confound CSU assessments based on the investigators clinical judgment.
- •Any other active pruritic skin diseases that would confound CSU assessments based on the investigator clinical judgment.
- •Planned or anticipated use of any prohibited medications during screening and study treatment, and follow-up.
- •Prior receipt of barzolvolimab or other anti-KIT therapy.
结局指标
主要结局
Evaluate the clinical effect of barzolvolimab, compared to placebo, in reducing urticaria
时间窗: Week 12
activity as assessed by weekly urticaria activity score (UAS7)
时间窗: Week 12
次要结局
- Evaluate the clinical effect of barzolvolimab, compared to placebo, in reducing urticaria(activity as assessed by weekly itch severity score (ISS7) and weekly hive severity score)
- valuate the clinical effect of barzolvolimab, compared to placebo, in reducing urticaria(activity in participants refractory to omalizumab treatment)
- Evaluate the clinical effect of barzolvolimab, compared to placebo, in reducing urticaria activity(Weeks 4, 24, and 52)
- Evaluate the clinical effect of barzolvolimab, compared to placebo, in reducing urticaria(activity in participants refractory to omalizumab treatment)
- Evaluate the clinical effect of barzolvolimab on the health-related quality of life(Weeks 12, 24, and 52)
研究者
研究点 (15)
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