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

NCT02059291 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2018-05-17

Study results available
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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.

Conditions

  • Hereditary Periodic Fevers

Interventions

DRUG

Canakinumab

Canakinumab solution for subcutaneous injection in vial which contained 150mg/mL canakinumab in 1 mL solution.

DRUG

Placebo

Matching placebo to canakinumab solution for subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-27
Primary Completion
2017-07-04
Completion
2017-07-04

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Russia
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02059291 on ClinicalTrials.gov