Overview

Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers

Status:
Completed

Trial end date:
2017-07-04

Target enrollment:
0

Participant gender:
All

Summary

This study is to determine whether canakinumab is able to induce and maintain a clinically meaningful reduction of disease activity in participants with Hereditary Periodic Fevers (HPF) compared to placebo.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novartis Pharmaceuticals

Treatments:

Antibodies, Monoclonal

Criteria

Inclusion Criteria: - Patient's written informed consent (or parent's written informed
consent in case of pediatric patient) at screening - Male and female patients at least 2
years of age at the time of the screening visit. Male and female patients >28 days but <2
years eligible for open label treatment only. - Confirmed diagnosis and active flare at
randomization - CRP >10mg/L at randomization

Exclusion Criteria: - Use of the following therapies (within varying protocol defined
timeframes): Corticosteroids, anakinra, canakinumab, rilonacept, tocilizumab, TNF
inhibitors, abatacept, tofacitinib, rituximab, leflunomide, thalidomide, cyclosporine,
intravenous immunoglobulin, 6-Merceptopurine, azathioprine, cyclophosphamide, or
chlorambucil, any other investigational biologics - History of malignancy of any organ
system (other than localized basal cell carcinoma of the skin or in - situ cervical
cancer), treated or untreated - Significant medical diseases, including but not limited to
the following: a. History of organ transplantation b. Elevated liver enzymes ≥3x ULN d.
Increase in total bilirubin e. Serious hepatic disorder (Child-Pugh scores B or C) f.
Chronic Kidney Disease g. Thyroid disease h. Diagnosis of active peptic ulcer disease i.
Coagulopathy j. Significant CNS effects including vertigo and dizziness - Any conditions or
significant medical problems which immunecompromise the patient and/or places the patient
at unacceptable risk for immunomodulatory therapy - Live vaccinations within 3 months prior
to the start of the trial, during the trial, and up to 3 months following the last dose