Kawasaki DiseasePhase 2NCT02980263
Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease
A Phase 2 study testing Canakinumab in people with Kawasaki Disease, run by Novartis Pharmaceuticals.
Trial summary
The purpose of this trial is to evaluate whether, in Intravenous Immunoglobulin-naïve or refractory patients diagnosed with active Kawasaki disease, administration of canakinumab controls fever and acute phase reactants. Read more about this study
- Who is it for?
- Ages 28 days to 10 years
- Conditions the study is for
- Kawasaki Disease
- What is being tested?
- Canakinumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2016to 30 Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -Active Kawasaki disease defined as:
- fever ≥38.5°C for ≥5 days
- four out of five of the following criteria: (i) conjunctival injection, (ii) oral mucous membrane changes, (e.g., injected pharynx, or strawberry tongue), (iii) erythema of hands or feet, (iv) polymorphous rash, (v) cervical lymphadenopathy
Who cannot join
- Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- Previous Kawasaki Disease diagnosis, refractory and/or incomplete Kawasaki disease (for IVIG-naïve patients, Cohort 1)
- Patients who had fever for longer than a week (for Intravenous Immunoglobulin-naïve patients, Cohort 1), or longer than 14 days (for Intravenous Immunoglobulin-refractory patients, Cohort 2)
- History of hypersensitivity to any of the study drugs or to drugs or similar chemical classes or excipients (e.g. citric acid and anhydrous sodium chloride disodium edetate dehydrate polysorbate 80; sodium hydroxide; water for injections)
- Other protocol-defined inclusion/exclusion may apply.
About this study
The purpose of this trial is to evaluate whether, in Intravenous Immunoglobulin-naïve or refractory patients diagnosed with active Kawasaki disease, administration of canakinumab controls fever and acute phase reactants.
- Conditions
- Kawasaki Disease
- Being tested
- Canakinumab
- Keywords
- Kawasaki disease, Coronary artery aneurysm, mucocutaneous lymph node syndrome, lymph node syndrome, canakinumab, intravenous immunoglobulin naïve (IVIG-naïve), intravenous immunoglobulin refractory (IVIG-refractory), pediatric
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome, Coronary Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanakinumabDrug
Also called ACZ885
| Study group | Role | What they receive |
|---|---|---|
| Kawasaki patients | Experimental | Not described Receives: Drug: Canakinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
resolution of fever
Measured: Day 3/4
Secondary outcomes (7)
proportion of patients with C-reactive Protein reduction
Measured: 12 weeks
proportion of patients developing coronary artery aneurysms
Measured: 12 weeks
time to resolution of fever
Measured: 12 weeks
proportion of patients with remittent fever
Measured: 12 weeks
size of coronary artery aneurysm
Measured: 24 weeks
Coronary artery aneurysm evolution over time
Measured: 12 weeks
proportion of patients with coronary artery aneurysm
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start15 Nov 2016 (estimated)
- Primary completion30 Nov 2017 (estimated)
- Study completion30 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980263
- Sponsor's protocol ID
- CACZ885D2208
- Status last verified
- Feb 2017
- First submitted
- 24 Oct 2016
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease
- ClinicalTrials.gov ID
- NCT02980263
- Acronym / sponsor ID
- CACZ885D2208
- Conditions
- Kawasaki Disease
- Keywords
- Kawasaki disease, Coronary artery aneurysm, mucocutaneous lymph node syndrome, lymph node syndrome, canakinumab, intravenous immunoglobulin naïve (IVIG-naïve), intravenous immunoglobulin refractory (IVIG-refractory), pediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2016 (estimated)
- Primary completion
- 30 Nov 2017 (estimated)
- Study completion
- 30 Nov 2017 (estimated)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to evaluate whether, in Intravenous Immunoglobulin-naïve or refractory patients diagnosed with active Kawasaki disease, administration of canakinumab controls fever and acute phase reactants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kawasaki patients | Experimental | Drug: Canakinumab |
Who may qualify
- Ages
- 28 days to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- fever ≥38.5°C for ≥5 days
- four out of five of the following criteria: (i) conjunctival injection, (ii) oral mucous membrane changes, (e.g., injected pharynx, or strawberry tongue), (iii) erythema of hands or feet, (iv) polymorphous rash, (v) cervical lymphadenopathy
Key exclusion criteria (5 listed)
- Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- Previous Kawasaki Disease diagnosis, refractory and/or incomplete Kawasaki disease (for IVIG-naïve patients, Cohort 1)
- Patients who had fever for longer than a week (for Intravenous Immunoglobulin-naïve patients, Cohort 1), or longer than 14 days (for Intravenous Immunoglobulin-refractory patients, Cohort 2)
- History of hypersensitivity to any of the study drugs or to drugs or similar chemical classes or excipients (e.g. citric acid and anhydrous sodium chloride disodium edetate dehydrate polysorbate 80; sodium hydroxide; water for injections)
- Other protocol-defined inclusion/exclusion may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CanakinumabAlso: ACZ885 | Drug | Kawasaki patients |
Primary outcome
resolution of fever
Time frame: Day 3/4
7 secondary outcomes
proportion of patients with C-reactive Protein reduction
Time frame: 12 weeks
proportion of patients developing coronary artery aneurysms
Time frame: 12 weeks
time to resolution of fever
Time frame: 12 weeks
proportion of patients with remittent fever
Time frame: 12 weeks
size of coronary artery aneurysm
Time frame: 24 weeks
Coronary artery aneurysm evolution over time
Time frame: 12 weeks
proportion of patients with coronary artery aneurysm
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Kawasaki Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 2/3
Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease
Kawasaki Disease
RecruitingPhase 4
Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease
Kawasaki Disease, Pilot Study
RecruitingObservational study
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension
RecruitingPhase 4
Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease
Kawasaki Disease, Coronary Artery Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Canakinumab in people with Kawasaki Disease, run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resolution of fever (time frame: Day 3/4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.