An Open Label, Single Arm Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of HL2351 in Patients With Cryopyrin Associated Periodic Syndromes

Handok Inc.1 个研究点分布在 1 个国家目标入组 8 人开始时间: 2015年10月最近更新: 2017年1月4日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: Handok Inc.
入组人数: 8
试验地点: 1
主要终点: Pharmacokinetic profile(Tmax)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an open label, single arm trial to evaluate the efficacy, safety, and pharmacokinetics of HL2351 in patients with cryopyrin associated periodic syndromes (CAPS).

详细描述

This trial enrolls patients with CAPS being on stable dose of anakinra daily and then switch over HL2351 given once weekly. It consists of 4 phases, 6-week screening, single dose PK, 6-month multiple dose, and 18-month extension phase.

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

性别: All
接受健康志愿者: 否

入选标准

•Documented molecular diagnosis of NALP3 mutation or diagnosis of CAPS based on sign and symptom
•Diagnosis of CAPS based on signs and symptoms
•Current stable doses of anakinra, alone or in combination with methotrexate or corticosteroids

排除标准

•Patient been diagnosed with a hereditary periodic fever syndrome or autoinflammatory disease other than CAPS
•Patients whose disease is inadequately controlled on current stable doses of anakinra, alone or in combination with methotrexate or corticosteroids

研究组 & 干预措施

HL2351

Experimental

干预措施: HL2351 (Drug)