An extension study of safety of canakinumab in Japanese patients with periodic fever syndromes

• Register: EUCTR
• Last refreshed on: 22 May 2017
• Main ID: EUCTR2017-001678-40-Outside-EU/EEA
• Date of registration: 15/05/2017
• Prospective Registration: Yes
• Primary sponsor: Novartis pharma AG
• Public title: An extension study of safety of canakinumab in Japanese patients with periodic fever syndromes
• Scientific title: An extension study of safety of canakinumab in Japanese patients with periodic fever syndromes
• Target sample size: 4
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001678-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Japan

Contacts

• Name: Clinical trial Information Desk
• Affiliation: Novartis pharma AG

• Name: Clinical trial Information Desk
• Affiliation: Novartis pharma AG

Key inclusion & exclusion criteria

Inclusion criteria:
Key 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



Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Key Exclusion criteria: Any conditions or significant medical problems in which the investigator judges the patient should not enter this extension study


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Three disease of periodic fever syndromes, TNF receptor Associated Periodic Syndrome (TRAPS), Hyper IgDSyndrome (HIDS)/ Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF
MedDRA version: 20.0 Level: SOC Classification code 10010331 Term: Congenital, familial and genetic disorders System Organ Class: 10010331 - Congenital, familial and genetic disorders

Intervention(s)

Trade Name: Ilaris
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CANAKINUMAB
CAS Number: 914613-48-2
Current Sponsor code: ACZ885
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 4-

Primary Outcome(s)

Secondary Objective: Not Applicable

Primary end point(s): Timeframe: Participants will be followed for the duration until approval, an expected average of 3 months.

Outcome Measure Description: To evaluate the safety and tolerability of canakinumab

Main Objective: The primary objective of this study is to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offers the opportunity for patients who completed Epoch 4 of the preceding CACZ885N2301 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 is suspended.

Timepoint(s) of evaluation of this end point: Timeframe: Participants will be followed for the duration until approval, an expected average of 3 months.

Outcome Measure Description: To evaluate the safety and tolerability of canakinumab

Secondary Outcome(s)

Secondary end point(s): Participants will be followed for the duration until approval, an expected average of 3 months.

Outcome Measure Description: To evaluate the safety and tolerability of canakinumab

Timepoint(s) of evaluation of this end point: Participants will be followed for the duration until approval, an expected average of 3 months.

Outcome Measure Description: To evaluate the safety and tolerability of canakinumab

Secondary ID(s)

CACZ885N2301E2

Source(s) of Monetary Support

Novartis pharma AG