NCT05512598已完成1 期
Multi-centre, Open-label, Single-arm, Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of a Single Dose of HB0034 in Patients Acute Generalized Pustular Psoriasis (GPP) Flare
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of patients with drug related adverse events
研究概览
简要总结
This is a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients with generalized pustular psoriasis (GPP ).
详细描述
This is an open-label, multicenter, phase Ib exploratory study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients presenting moderate-severe generalized pustular psoriasis (GPP ) flare.
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
- •Male or female patients, aged 18 to 75 years at screening
- •A known and documented history of Generalized Pustular Psoriasis diagnosed with ERASPEN criteria
- •Presenting with a moderate-severe flare of Generalized Pustular Psoriasis (GPP)
- •Patients must be able to understand and sign a written informed consent document and complete study-related procedures and questionnaires.
排除标准
- •Immediate life-threatening flare of Generalized Pustular Psoriasis or requiring intensive care treatment, according, to the judgment of the investigator. Life-threatening complications mainly include but are not limited to, cardiovascular/cytokine-driven shock, pulmonary distress
- •History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia)
- •Pregnant or Breasting feeding subject. Women with a positive pregnancy test.
- •Ongoing use of prohibited psoriasis treatments
- •Further exclusions criteria apply
研究组 & 干预措施
HB0034
Experimental
Recombinant Humanized Anti-IL-36R Monoclonal antibody
干预措施: HB0034 (Drug)
结局指标
主要结局
Number of patients with drug related adverse events
时间窗: 90 days
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug
次要结局
- Proportion of Patients achieved GPPAG pustular 0/1 (pustular cleared or almost cleared)(12 weeks)
- Cmax(12 weeks)
- AUC0-infinity(12 weeks)
研究者
研究点 (1)
Loading locations...
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