An Open Label, Phase 1 Single Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 as Add on Therapy in Patients With Cold Contact Urticaria, Symptomatic Dermographism and Cholinergic Urticaria
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Safety as assessed by the incidence and severity of adverse events
研究概览
简要总结
This is a study to determine the safety of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria.
详细描述
This study is an open label Phase 1 study evaluating the safety, pharmacokinetics, and pharmacodynamics of a single dose of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria who remain symptomatic despite treatment with antihistamines. Twenty patients with Cold Contact Urticaria, ten patients with Symptomatic Dermographism, and ten patients with Cholinergic Urticaria will be enrolled in four separate cohorts for a total of 40 patients.
Prospective patients will be screened with tests in clinic as well as daily at home diaries for 2 weeks prior to enrollment. CDX-0159 will be administered intravenously on Day 1. Post-treatment, patients will be followed for 12 weeks with an optional longer term follow up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria which does not respond to antihistamines
- •Diagnosis for ≥ 3 months; symptoms of both hive (wheal) and itch/burning/painful sensation despite concurrent use of anti-histamines
- •During screening, in clinic, for Cold Contact Urticaria, patients must have a positive cold stimulation test, for Symptomatic Dermographism, patients must have a positive FricTest®, and for Cholinergic Urticaria, patients must have a positive pulse-controlled ergometry (PCE) provocation test
- •On stable dose of antihistamines
- •Other than a diagnosis of Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria, no other conditions which would introduce additional risk factors or would interfere with the study procedures, as determined by the investigator, based on a medical evaluation
- •Female and male patients must use highly effective contraception from the time of the screening visit and for at least 150 days after receipt of study treatment
- •Willing and able to comply with all study requirements and procedures including completion of a daily medication diary and questionnaires
排除标准
- •A clearly defined diagnosis of hives or angioedema other than chronic urticaria.
- •Receipt of prior biologic therapy (e.g.: omalizumab, dupilumab, ligelizumab) within past 3 months
- •Treatment with immunosuppressives (e.g. systemic corticosteroids, cyclosporine, methotrexate, dapsone, cyclophosphamide, tacrolimus and mycophenolate mofetil, hydroxychloroquine or others) within 4 weeks or 5 half lives
- •Active COVID-19 infection
- •HIV, hepatitis B or hepatitis C infection
- •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
20 patients with Cold Contact Urticaria, 10 patients with Symptomatic Dermographism, and 10 patients with Cholinergic Urticaria will be enrolled and treated with a single dose of CDX-0159
干预措施: CDX-0159 (Drug)
结局指标
主要结局
Safety as assessed by the incidence and severity of adverse events
时间窗: From Day 1 through week 12
Safety of a single dose of CDX-0159 as determined by adverse events
次要结局
- For patients with Symptomatic Dermographism, change in provocation thresholds(From Day 1 to Day 85)
- Blood Biomarkers(From Day 1 to Day 85)
- Pharmacokinetic Evaluation(From Day 1 to Day 85)
- For patients with Cold Contact Urticaria, Change in Critical Temperature Thresholds (CTT)(From Day 1 to Day 85)
- For patients with Cholinergic Urticaria, changes in baseline Urticaria Activity Score Provocation (UASprovo)(From Day 1 to Day 85)
- Changes from baseline in Urticaria Control Test (UCT)(From Day 1 to Day 85)
- Immunogenicity Evaluation(From Day 1 to Day 85)