HL2351 CAPS Phase II Study

• Status: Terminated
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Handok Inc.; Handok Pharmaceuticals Co., Ltd.

Criteria

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