|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
30 June 2019 |
|
Main ID: |
EUCTR2009-016859-22-FR |
|
Date of registration:
|
14/06/2010 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A one-year open-label, multicenter trial to assess efficacy, safety and tolerability of canakinumab (ACZ885) and the efficacy and safety of childhood vaccinations in patients aged 4 years or younger with Cryopyrin Associated Periodic Syndromes (CAPS).
|
|
Scientific title:
|
A one-year open-label, multicenter trial to assess efficacy, safety and tolerability of canakinumab (ACZ885) and the efficacy and safety of childhood vaccinations in patients aged 4 years or younger with Cryopyrin Associated Periodic Syndromes (CAPS). |
|
Date of first enrolment:
|
04/02/2013 |
|
Target sample size:
|
15 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016859-22 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
|
|
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
|
France
|
Germany
|
Ireland
|
Spain
|
United Kingdom
| | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
1. Male and female patients that are 28 days up to 60 months of age at the time of the screening visit.
2. Body weight = 2.5 kg.
3. Parent or legal guardian’s written informed consent is required before any assessment is performed for patients.
4. At study entry, patients should have a clinical diagnosis of FCAS, MWS, or NOMID and symptoms requiring pharmacological intervention. Prior agreement between the
Investigator and Novartis for study eligibility is required for patients who do not have a molecular diagnosis of NALP3 mutations available (either testing not performed, or testing performed but negative) upon study entry. For those patients who have not been molecularly tested for NALP3 mutations, molecular testing should be performed during the course of the study.
5. For patients treated with an IL-1 blocking agent (i.e. anakinra, rilonacept), these
treatments should be discontinued prior to the baseline visit and patients must demonstrate active disease prior to treatment.
6. Patients who are scheduled to receive an immunization, according to their local
vaccination guidelines, with an inactivated vaccine must be willing to participate in the assessment schedule for vaccinated patients.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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. Preterm neonates for whom, in the Investigator’s judgment, participation in the study is not deemed appropriate.
2. History of recurrent and/or evidence of active bacterial, fungal, or viral infections (including HIV).
3. Patients with immunodeficiency or treatment with immunosuppressive drugs.
4. Live vaccinations within =3 months prior to screening. No live vaccinations will be allowed throughout the course of this study and up to 3 months following the last dose.
?5. Patients with an increased risk of tuberculosis (TB) infection according to following risk factors:
• Patients with recent close contact with persons known to have active pulmonary TB disease
• Foreign-born patients from countries with a high prevalence of tuberculosis
• Patients with recent tuberculosis infection (including children > 6 months with a positive PPD test [defined as an induration of at least 10mm])
• Patients with end-stage renal disease
• Patients with diabetes mellitus
• Patients receiving immunosuppressive therapy
• Patients with hematologic cancers.
6. Participation in another trial within the last 30 days or 5 half-lives of the investigational compound (whichever is longer).
7. Familial and social conditions rendering regular medical assessment not possible.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Cryopyrin Associated Periodic Syndromes (CAPS)
MedDRA version: 12.1
Level: LLT
Classification code 10068850
Term: Cryopyrin associated periodic syndrome
|
|
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
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
|
|
Primary Outcome(s)
|
|
Primary end point(s): To assess the safety, tolerability and efficacy of canakinumab with respect to the treatment response in CAPS patients 4 years and younger.
|
Secondary Objective: • To assess the efficacy of canakinumab with respect to the treatment response in patients 2 years and younger
• Safety and tolerability as assessed by overall frequency of adverse events and number of patients completing the study in patients 2 years and younger and the overall population
• To assess the presence of protective antibody levels following immunization with inactivated (killed) vaccines
• To evaluate the safety of canakinumab treatment in pediatric patients receiving a concomitant vaccination
• The proportion of patients with vaccination-associated reactions
• To assess the number of patients who relapse as determined by the Physician’s global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers
• To assess the reduction of inflammation markers (C-reactive protein (CRP) and/or serum amyloid A (SAA) after treatment initiation
See other objectives into the protocol page 20.
|
|
Main Objective: To assess the efficacy of canakinumab with respect to the treatment response in patients 4 years and younger
|
|
Secondary ID(s)
|
|
CACZ885D2307
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
|
|