An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes

Phase 3

Completed

• Conditions: Periodic Fevers Syndrome
• Interventions: Biological: Canakinumab (AIN457)

• Registration Number: NCT02911857
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-22
• Study Start: 2016-10-03
• Primary Completion: 2017-01-27
• Study Completion: 2017-01-27
• Results First Submitted: 2017-07-25
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-30
• Last Update Submitted: 2017-11-30
• Results First Posted: 2018-08-20
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Completed Epoch 4 of the CACZ885N2301 study in Japan before the approval of canakinumab in Japan
• Written informed consent. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients < 20 years of age

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Exclusion Criteria

• Any conditions or significant medical problems in which the investigator judges the patient should not enter this extension study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Canakinumab (ACZ885)	Canakinumab (AIN457)	Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths	Participants were followed for the duration until approval, an expected average of 3 months.	Participants were monitored for safety throughout the study.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Kyoto-city, Kyoto, Japan