Safety, Efficacy, Pharmacokinetics, Pharmacodynamics of ACZ885 in Patients With NALP3 Mutations and Clinical Symptoms

Sponsor: Novartis Pharmaceuticals
Study ID: NCT00487708
Phase: PHASE2
Status: Completed

Conditions

NALP3 Mutation

Eligibility Criteria

Sex: ALL
Age: 4 Years - 75 Years
Healthy Volunteers: Not accepted

Interventions

canakinumab — DRUG

Study Details

This study will investigate the clinical efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of ACZ885, administered intravenously and subcutaneously to patients with NALP3 mutations whose clinical symptoms are either untreated or insufficiently treated and require medical intervention.

Key Dates

Start date: Jan 31, 2005
Status verified: Feb 2009
Primary completion: Jul 31, 2008
Completion: Jul 31, 2008

Study Design

Enrollment: 34 participants (actual)
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: 1
ACZ885

Primary Outcome Measure

Response to treatment and time to relapse after ACZ885 administration according to monthly investigator's clinical assessments, laboratory monitoring, and patient diaries. [ Time Frame: Every month ]