Overview

This trial is active, not recruiting.

Condition hereditary periodic fevers
Treatments canakinumab, placebo
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date June 2014
End date June 2017
Trial size 204 participants
Trial identifier NCT02059291, CACZ885N2301

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
subcutaneous injection
canakinumab ACZ885
subcutaneous injection
(Placebo Comparator)
subcutaneous injection
placebo
subcutaneous injection
(Experimental)
subcutaneous injection (open label)
canakinumab ACZ885
subcutaneous injection

Primary Outcomes

Measure
Proportion of participants with resolution of initial flare and absence of new flares
time frame: 16 weeks

Secondary Outcomes

Measure
Percentage of participants who achieve Physician's global assessment < 2
time frame: 16 weeks
Percentage of participants with the serologic remission
time frame: 16 weeks

Eligibility Criteria

Male or female participants at least 1 month old.

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

Additional Information

Official title Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Novartis.