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

Novartis

Status and phase: Completed; Phase 3

Conditions: Periodic Fevers Syndrome

Treatments: Biological: Canakinumab (AIN457)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02911857

CACZ885N2301E2

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Canakinumab (ACZ885)

Experimental group

Description:

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.

Treatment:

Biological: Canakinumab (AIN457)