A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single Dose Study to Assess the Safety, Pharmacokinetics, and Clinical Effect of CDX-0159 in Patients With Prurigo Nodularis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 17
- 主要终点
- Safety and tolerability as assessed by the incidence and severity of adverse events
研究概览
简要总结
The purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and pharmacokinetics of CDX-0159 (barzolvolimab) in patients with Prurigo Nodularis.
详细描述
The purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and pharmacokinetics of CDX-0159 (barzolvolimab) in patients with Prurigo Nodularis.
There is a screening period of up to 2 weeks, an 8-week double-blind treatment period and a 16-week follow-up period after treatment. Patients will receive one dose of CDX-0159 (barzolvolimab) or placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 18 - 75 years old.
- •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 (IGA) 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) twice daily 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 lesions of prurigo (eg, only one arm affected)
- •Active unstable pruritic skin conditions in addition to PN.
- •Women 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.
- •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
CDX-0159 1.5mg/kg
CDX-0159 1.5mg/kg administered once
干预措施: CDX-0159 (Biological)
CDX-0159 3mg/kg
CDX-0159 3.0 mg/kg administered once
干预措施: CDX-0159 (Biological)
Placebo
Normal saline administered once
干预措施: Normal saline (Drug)
结局指标
主要结局
Safety and tolerability as assessed by the incidence and severity of adverse events
时间窗: From Day 1 (first dose) to Day 169 (last follow-up visit)
Safety and tolerability of multiple dose levels of CDX-0159 as determined by drug related adverse events
次要结局
- Pharmacokinetic evaluation(From Day 1 (before first dose) to Day 169 (last follow-up visit))
- Clinical effect of CDX-0159 on pruritus(From Day 1 (first dose) to Day 57 (week 8))