HL2351 CAPS Phase II Study

Handok

Status and phase: Terminated; Phase 2

Conditions: Cryopyrin-Associated Periodic Syndromes (CAPS)

Treatments: Drug: HL2351

Study type: Interventional

Funder types: Industry

Identifiers

NCT02853084

HL_C201

Details and patient eligibility

About

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).

Full 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.

Enrollment: 8 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

HL2351

Experimental group

Treatment:

Drug: HL2351