2024-513208-32-00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 – CSU1)
Celldex Therapeutics Inc.102 个研究点 分布在 5 个国家目标入组 521 人开始时间: 2024年11月5日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 521
- 试验地点
- 102
- 主要终点
- Mean change from baseline in UAS7 at Week 12
研究概览
简要总结
To evaluate the clinical effect of barzolvolimab, compared to placebo, in reducing urticaria activity as assessed by weekly urticaria activity score (UAS7) at Week 12
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow-up Phase
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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, ≥ 18 years of age at the time of signing the informed consent.
- •CSU ≥ 6 months prior to Screening. Note: the investigator should establish the presence of CSU for the noted duration based on all available supporting documentation, including written medical records and communication with the participants’ previous healthcare providers, if applicable.
- •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 ≥ 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 secondgeneration H1 antihistamine (H1AH) at approved or increased (up to 4x approved) dose as background therapy for the treatment of CSU for ≥ 4 weeks prior to randomization and which is expected to remain stable throughout the study. • UAS7 (range: 0 to 42) ≥ 16 and ISS7 (range: 0 to 21) ≥ 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).
- •Chronic urticaria whose predominant manifestation is due to CIndU including symptomatic dermographism [urticaria factitia], cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact urticaria Note: CIndU is not excluded per se
- •Any other active pruritic skin diseases that would confound CSU assessments (e.g., atopic dermatitis, psoriasis, bullous pemphigoid, dermatitis herpetiformis, prurigo nodularis, chronic pruritus of unknown origin) based on the investigator's clinical judgment.
- •Prior receipt of barzolvolimab or other anti-KIT therapy.
结局指标
主要结局
Mean change from baseline in UAS7 at Week 12
Mean change from baseline in UAS7 at Week 12
次要结局
- Mean change from baseline in ISS7 and HSS7 at Week 12
- Percent of participants with UAS7 = 0 at Week 12
- Mean change from baseline in UAS7 in participants refractory to omalizumab treatment at Week 12
- Proportion of participants with UAS7 = 0 in participants refractory to omalizumab treatment at Week 12.
- Percent of participants with UAS7 ≤ 6 at Week 12
- Mean change from baseline in UAS7 at Week 4
- Mean change from baseline in UAS7 at Week 24
- Percent of participants with UAS7 = 0 at Week 24
研究者
Science Department
Scientific
Celldex Therapeutics Inc.
研究点 (102)
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