At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 203 enrolled
Drug / intervention
Canakinumab +1 moredrug
Likely dose
Canakinumab 150mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo Controlled Study of Canakinumab in Patients With Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), With Subsequent Randomized Withdrawal/Dosing Frequency Reduction and Open-label Long-term Treatment Epochs
In Brief
A Phase 3 clinical trial evaluating Canakinumab and Placebo for Hereditary Periodic Fevers. Completed, enrolled 203 participants across 65 sites in 16 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Periodic Fevers
CountriesBelgium, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Russia, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartJun 2014
Primary CompletionJul 2017
TodayJul 2026
First PostedFeb 11, 2014
Enrollment StartJun 27, 2014
Primary CompletionJul 4, 2017
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 12.4 years ago
Interventions
Canakinumabdrug
Canakinumab solution for subcutaneous injection in vial which contained 150mg/mL canakinumab in 1 mL solution.
Placebodrug
Matching placebo to canakinumab solution for subcutaneous injection