A study to check how safe, beneficial and tolerable the drug canakinumab, along with childhood vaccines, is for patients with crypoyrin associated periodic syndromes (CAPS).

• Register: EUCTR
• Last refreshed on: 22 August 2016
• Main ID: EUCTR2011-005154-57-BE
• Date of registration: 06/12/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: A study to check how safe, beneficial and tolerable the drug canakinumab, along with childhood vaccines, is for patients with crypoyrin associated periodic syndromes (CAPS).
• Scientific title: An open-label extension study to assess efficacy, safety and tolerability of canakinumab and the efficacy and safety of childhood vaccinations in patients with Cryopyrin Associated Periodic Syndromes (CAPS) - D2307E1
• Date of first enrolment: 03/01/2012
• Target sample size: 16
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005154-57
• 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 Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Canada, France, Germany, Israel, Spain, United Kingdom

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:

1.Patients who completed the core CACZ885D2307 study (a patient is defined as having completed the core study if they completed the study up to and including the EOS visit with no major protocol deviations in the core).
2.Male and female patients that are = 1 year of age at the time of the roll-over visit.
3.Parent or legal guardian written informed consent must be obtained before any assessment in the extension CACZ885D2307E1 study is performed.

Other protocol-defined inclusion/exclusion criteria may apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 16
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1.Patients for whom continued treatment in the CACZ885D2307E1 extension study is not considered appropriate by the treating physician.
2.Patients who discontinued from the core CACZ885D2307 study.

Other protocol-defined inclusion/exclusion criteria may apply


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

Health Condition(s) or Problem(s) studied

Cryopyrin Associated Periodic Syndromes (CAPS)
MedDRA version: 14.0 Level: PT Classification code 10068850 Term: Cryopyrin associated periodic syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders

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

Intervention(s)

Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: CANAKINUMAB
CAS Number: 914613-48-2
Current Sponsor code: ACZ885
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Lyophilisate for solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: •Safety and tolerability as assessed by the overall frequency of adverse events and the number of patients completing the extension study in the overall population
•To assess the presence of protective antibody levels following immunization with inactivated (killed) vaccines administered during the extension study
•To assess the safety of canakinumab treatment in pediatric patients receiving a concomitant vaccination during the extension study
•To assess the proportion of patients with vaccination-associated reactions during the extension study
•To assess efficacy with regards to the Physician’s Global Assessment of autoinflammatory disease activity and assessment of skin disease
•To evaluate the efficacy of canakinumab with regards to inflammatory markers (C-reactive protein (CRP) or serum amyloid A (SAA)
[...]

Timepoint(s) of evaluation of this end point: A minimum of 6 months and maximum of 24 months

Main Objective: To assess the long-term efficacy of canakinumab with respect to the maintenance of treatment response in CAPS patients who completed the CACZ885D2307 study

Primary end point(s): To assess the long-term efficacy of canakinumab with respect to the maintenance of treatment response in CAPS patients who completed the CACZ885D2307 study

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: A minimum of 6 months and maximum of 24 months

Secondary end point(s): 1. Safety and tolerability as assessed by the overall frequency of adverse events and the number of patients completing the extension study in the overall population
2. To assess the presence of protective antibody levels following immunization with inactivated (killed) vaccines (see Section 6.1 of protocol) administered during the extension study
3. To assess the safety of canakinumab treatment in pediatric patients receiving a concomitant vaccination during the extension study
4. To evaluate the proportion of patients with vaccinated-associated reactions
5. To assess efficacy with regards to the Physician’s Global Assessment of autoinflammatory disease activity and assessment of skin disease
6. To assess the reduction of inflammation marker (C-reactive protein (CRP) or serum amyloid A (SAA) after treatment initiation

Secondary ID(s)

CACZ885D2307E1

Source(s) of Monetary Support

Novartis Pharma Services AG