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
- 516
- 主要终点
- Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
研究概览
简要总结
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
详细描述
This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose.
There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period.
Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, >/= 18 years of age.
- •Chronic spontaneous urticaria (CSU) >/= 6 months prior to Screening (Visit 1).
- •CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
- •The presence of hives for >/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines.
- •Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment.
- •UAS7 of >/= 16 and ISS7 of >/= 8 during the 7 days prior to study treatment.
- •Normal blood counts and liver function tests.
- •Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
- •Willing and able to complete a daily symptom electronic diary and comply with study visits.
- •Participants with and without prior biologic experience are eligible.
排除标准
- •Women who are pregnant or nursing.
- •Chronic urticaria whose predominant manifestation is due to CIndU.
- •Other diseases associated with urticaria.
- •Active pruritic skin condition in addition to CSU.
- •Medical condition that would cause additional risk or interfere with study procedures.
- •Known HIV, hepatitis B or hepatitis C infection.
- •Vaccination of a live vaccine within 30 days prior to Screening (Visit 1) (subjects must agree to avoid live vaccinations during the study). Inactivated vaccines are allowed such as seasonal influenza injection or authorized COVID-19 vaccine.
- •History of anaphylaxis
- •Prior treatment with barzolvolimab
- •There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
研究组 & 干预措施
barzolvolimab 300 mg
barzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks
干预措施: barzolvolimab (Biological)
Placebo then barzolvolimab 150 mg
Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 300 mg followed by 150 mg administered every 4 weeks for 28 weeks.
干预措施: barzolvolimab (Biological)
barzolvolimab 150 mg
barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks
干预措施: barzolvolimab (Biological)
Placebo then barzolvolimab 150 mg
Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 300 mg followed by 150 mg administered every 4 weeks for 28 weeks.
干预措施: Matching placebo (Biological)
Placebo then barzolvolimab 300 mg
Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 450 mg followed by 300 mg administered every 8 weeks for 28 weeks.
干预措施: barzolvolimab (Biological)
Placebo then barzolvolimab 300 mg
Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 450 mg followed by 300 mg administered every 8 weeks for 28 weeks.
干预措施: Matching placebo (Biological)
结局指标
主要结局
Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
时间窗: From Day 1 (first dose) to Day 85 (Week 12)
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS). The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
次要结局
- Proportion of participants with UAS7 = 0 in participants refractory to omalizumab treatment at Week 12(From Day 1 (first dose) to Day 85 (Week 12))
- Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)(From Day 1 (first dose) to Day 85 (Week 12))
- Percentage of patients with UAS7=0 at Week 12(From Day 1 (first dose) to Day 85 (Week 12))
- Mean change from baseline in UAS7 in participants refractory to omalizumab treatment at Week 12(From Day 1 (first dose) to Day 85 (Week 12))
- Incidence of Treatment-Emergent Adverse Events(From Day 1 (first dose) to Day 477 (Week 68))
- Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)(From Day 1 (first dose) to Day 85 (Week 12))
- Percentage of participants with UAS7 ≤ 6 at Week 12(From Day 1 (first dose) to Day 85 (Week 12))
- Percentage of participants with AAS7 > 0 at baseline with AAS7 = 0 at Week 12(From Day 1 (first dose) to Day 85 (Week 12))