CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4 enrolled
Drug / intervention
Canakinumab (AIN457)biological
Likely dose
Canakinumab (AIN457) 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.

Search/NCT02911857
NCT02911857Phase 3Completed
CompareCT.gov

An Extension Study of CACZ885N2301 (NCT02059291), Multi-center, Open Label Study of Canakinumab in Japanese Patients With Periodic Fever Syndromes (Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyper Immunoglobulin D Syndrome ((Also Known as Mevalonate Kinase Deficiency) (HIDS/MKD), or Colchicine Resistant/Intolerant Familial Mediterranean Fever (crFMF))

Novartis Pharmaceuticals·interventional·Posted Sep 22, 2016·Updated Aug 20, 2018

In Brief

A Phase 3 clinical trial evaluating Canakinumab (AIN457) for Periodic Fevers Syndrome. Completed, enrolled 4 participants across 3 sites.

Detailed Summary

The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offered the opportunity for participants who completed Epoch 4 of the preceding CACZ885N2301 (NCT02059291) study to continue to be treated with ACZ885 until approval in Japan of the drug in Periodic Fever Syndromes or until development of ACZ885 in Periodic Fever Syndromes was suspended.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeriodic Fevers Syndrome
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 22, 2016
Enrollment StartOct 3, 2016
Primary CompletionJan 27, 2017
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.8 years ago

Interventions

Canakinumab (AIN457)biological

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