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 site in 1 country8 target enrollmentStarted: October 2015Last updated: January 4, 2017

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Terminated
Sponsor: Handok Inc.
Enrollment: 8
Locations: 1
Primary Endpoint: Pharmacokinetic profile(Tmax)

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief 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.

Study Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•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

Exclusion Criteria

•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

Arms & Interventions

HL2351

Experimental

Intervention: HL2351 (Drug)