HL2351 CAPS Phase II Study

Cryopyrin-Associated Periodic Syndromes (CAPS) Clinical Trial

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

Status Terminated

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cryopyrin-Associated Periodic Syndromes
• Cryopyrin-Associated Periodic Syndromes (CAPS)
• Syndrome

• NCT number: NCT02853084
• Study type: Interventional
• Source: Handok Pharmaceuticals Co., Ltd.
• Status: Terminated
• Phase: Phase 2
• Start date: October 2015
• Completion date: January 2019