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

An Extension Study of CACZ885N2301, Multi-center, Open Label Study of Canakinumab in Japanese Patients With Periodic Fever Syndromes (TRAPS, HIDS, or crFMF)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223341

Enrollment

Registered

2016-10-04

Start date

2016-10-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Periodic Fevers

Interventions

investigational material(s) Generic name etc : ACZ885 INN of investigational material : canakinumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for In

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: *Any conditions or significant medical problems in which the investigator judges the patient should not enter this extension study Other protocol defined inclusion/exclusion may apply

Design outcomes

Primary

Measure	Time frame
Number and percentage of patients with adverse events [ Time Frame: Participants will be followed for the duration until approval, an expected average of 3 months ] To evaluate the safety and tolerability of canakinumab	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026