Study of efficacy and safety of canakinumab in pediatric patients with Kawasaki disease

A 12-week, open-label, parallel-cohort study to evaluate the efficacy, safety and tolerability of canakinumab in pediatric IVIG-naïve or refractory patients with active Kawasaki disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003763-11-IT

Enrollment

Registered

2016-03-11

Start date

2016-06-15

Completion date

Unknown

Last updated

2018-02-19

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

Conditions

Active Kawasaki disease MedDRA version: 18.1 Level: PT Classification code 10023320 Term: Kawasaki's disease System Organ Class: 10047065 - Vascular 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: Female and male patients =28 days and =10 years of age. 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 Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? yes Number of subjects for this age range: 26 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: Patients fulfilling any of the following criteria are not eligible for inclusion in this study: · Previous KD diagnosis, refractory and/or incomplete Kawasaki disease (for IVIG-naïve patients, Cohort 1) · Patients who had fever for longer than a week (for IVIG-naïve patients, Cohort 1), or longer than 14 days (for IVIG-refractory patients, Cohort 2) · History of hypersensitivity to any of the study drugs or to drugs of 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 exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to evaluate the proportion of patients with resolution of fever, defined as body temperature =37.5 °C =48 to 37.5 °C) by Day 29 · location, number and size of CAA at Days 29 and 85 · CAA evolution over time by echography at Days 43, 57 and 85 Other protocol-defined secondary objectives may apply.	—

Secondary

Measure	Time frame
Secondary end point(s): · proportion of patients with CRP =15 mg/L by =48 to 37.5 °C) by Day 29 · location, number and size of CAA at Days 29 and 85 · CAA evolution over time by echography at Days 43, 57 and 85 ;Timepoint(s) of evaluation of this end point: Duration of trial	—

Countries

Belgium, Germany, Italy, Netherlands, Poland, Switzerland, Turkey

Contacts

Public ContactDrug Regulatory Affairs

Novartis Farma SpA

info.studiclinici@novartis.com00390296542287

Outcome results

None listed

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