NCT06366750进行中（未招募）2 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Patients With Prurigo Nodularis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 72
- 主要终点
- Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12.
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis.
详细描述
The purpose of this study is to assess the efficacy and safety of barzolvolimab (CDX-0159) in adults with prurigo nodularis.
There is a screening period of approximately 28 days, a 24-week double-blind treatment period and a 16-week follow-up period after treatment. Participants will be randomly assigned on a 1:1:1 ratio to receive barzolvolimab (CDX-0159) by subcutaneous injections of 150 mg every 4 weeks (Q4W) after an initial loading dose of 450 mg, 300 mg Q4W after an initial loading dose of 450 mg, or placebo Q4W.
Following the completion of the treatment period, participants may enter an open label extension portion of the study if they are eligible.
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.
- •Diagnosis of Prurigo Nodularis by a dermatologist at least 3 months prior to Screening with:
- •At least 20 PN nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening.
- •An Investigators Global Assessment for stage of chronic nodular prurigo (IGA-CNPG-S) score for PN ≥ 3 at screening and Baseline (Day 1).
- •Severe itch, defined as the mean of the daily worst itch NRS (WI-NRS) score of ≥ 7 during the 7-day period immediately prior to initiation of study treatment.
- •Documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable.
- •Willing to apply a topical moisturizer (emollient) once or twice a day throughout the study.
- •Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment.
- •Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.
排除标准
- •PN due to neuropathy, psychiatric disorders or medications.
- •Unilateral PN lesions limited to small area on one side of the body (e.g., only one arm affected).
- •Active unstable pruritic skin conditions in addition to PN.
- •Documented atopic dermatitis (moderate to severe) within 6 months before the start of screening.
- •Females who are pregnant or nursing.
- •Known hepatitis B or hepatitis C infection or active COVID-19 infection.
- •Vaccination with a live vaccine within 2 months prior to study drug administration (subjects must agree to avoid vaccination during the study and for four months thereafter). NOTE: Inactivated vaccines are allowed such as seasonal influenza for injection. COVID-19 vaccination is allowed.
- •History of anaphylaxis.
- •Prior receipt of 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 450 mg, then 150 mg Q4W
Experimental
450 mg subcutaneous administration loading dose on Day 1 followed by 150 mg subcutaneous administration every 4 weeks, starting on Week 4, to Week 24.
干预措施: barzolvolimab (Biological)
Barzolvolimab 450 mg, then 300 mg Q4W
Experimental
450 mg subcutaneous administration loading dose on Day 1 followed by 300 mg subcutaneous administration every 4 weeks, starting on Week 4, to Week 24.
干预措施: barzolvolimab (Biological)
Placebo
Placebo Comparator
Matching placebo subcutaneous administration every 4 weeks, starting on Week 4, to Week 24.
干预措施: Matching Placebo (Other)
结局指标
主要结局
Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12.
时间窗: From Day 1 (first dose) to Day 85 (week 12)
WI-NRS is a validated measure of itch severity. Participants are asked daily to rate the intensity of their worst pruritis (itch) over the past 24 hours using an 11-point scale ranging from 0= no itch to 10= worst imaginable itch. Higher scores indicate more severity.
次要结局
- Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 4.(From Day 1 (first dose) to Week 4)
- Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 24.(From Day 1 (first dose) to Week 24)
- Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Day 169 (week 24).(From Day 1 (first dose) to Day 169 (week 24))
- Proportion of participants with Investigator Global Assessment for stage of chronic nodular prurigo score (IGA-CNPG-S) of 0 or 1 at Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Proportion of participants with improvement in both WI-NRS by ≥ 4 from baseline and IGA-CNPG-S score of 0 or 1 at Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Proportion of participants with Investigator Global Assessment for activity of chronic prurigo (IGA-CPG-A) score of 0 or 1 at Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Absolute change from baseline in WI-NRS at Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Percentage change from baseline in WI-NRS at Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Absolute change from baseline in Sleep Quality Numerical Rating Scale (SQ-NRS) at Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Percentage change from baseline in SQ-NRS at Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Absolute change from baseline in Worst Pain Numerical Rating Scale (WP-NRS) at Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Percentage change from baseline in WP-NRS at Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Absolute change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue - Short Form 7b Daily (PROMIS Fatigue-SF Daily) at Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Percentage change from baseline in PROMIS Fatigue-SF Daily at Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Absolute change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Percentage change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Proportion of participants with WI-NRS score < 2 at Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Proportion of participants with improvement in SQ-NRS by ≥ 4 from baseline to Week 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Proportion of participants with improvement in WP-NRS by ≥ 4 from baseline to Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Proportion of participants with improvement of ≥ 4 in DLQI from baseline to Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Proportion of participants achieving DLQI score of 0 or 1 at Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Absolute change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD.(From Day 1 (first dose) to Day 169 (week 24))
- Percentage change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD at Weeks 4, 12 and 24.(From Day 1 (first dose) to Day 169 (week 24))
- Number of participants with Treatment-Emergent Adverse Events (TEAEs) throughout the study.(From Day 1 (first dose) to Day 281 (last follow-up visit))
研究者
研究点 (72)
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