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).

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005154-57-BE

Enrollment

Registered

2011-12-06

Start date

2012-01-03

Completion date

Unknown

Last updated

2016-08-22

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

Conditions

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

Interventions

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:

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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;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) [...];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;Timepoint(s) of evaluation of this end point: A minimum of 6 months and maximum of 24 months	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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;Timepoint(s) of evaluation of this end point: A minimum of 6 months and maximum of 24 months	—

Measure

Time frame

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

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Countries

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

Contacts

Public ContactClinical Trial Information Desk

Novartis Pharma AG

clinicaltrial.enquiries@novartis.com+41613241111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026