NCT02853084

HL2351 CAPS Phase II Study

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Handok Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Cryopyrin-Associated Periodic Syndromes (CAPS)

Interventions

Type	Name	Description
DRUG	HL2351	The dose will be adjusted based on disease activities

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-05-01
• Completion: 2019-01-01
• First posted: 2016-08-02
• Last updated: 2017-01-04

Locations

1 site across 1 country: South Korea