Study of efficacy and safety of Canakinumab in patients with Kawasaki disease

A 12-month, open-label, parallel-cohort study to evaluate the efficacy, safety and tolerability of Canakinumab in Kawasaki disease - Kawakinumab study

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002783-27-NL

Enrollment

Registered

2019-08-15

Start date

2020-03-04

Completion date

Unknown

Last updated

2020-03-18

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: 20.0 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: Concentrate for solution for injection/infusion INN or Proposed INN: CANAKINUMAB CAS Number: 914613-48-2 Current

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The presence of a complete clinical diagnosis of Kawasaki Disease. Two patient categories are identified for patient inclusion: 1. IVIG-resistent patients (having fever at 48 hrs after start of IVIG); and 2. patients who have been diagnosed with Kawasaki disease before day 8 and have not yet been treated with IVIG. Inclusion of patients aged 0-12 years. Are the trial subjects under 18? yes Number of subjects for this age range: 10 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 who were successfully treated with IVIG. Aged 12 years or more, Patietns using immunosuppressive biologicals. Cardiac signs of mycocardial ischemia or infarction.

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy, tolerability and saftey of Canakinumab in Kawasaki Disease . The primary objective of this study is to evaluate the proportion of patients which show resolution of fever?;Secondary Objective: A: Does Canakinumab reduce the incidence of coronary artery lesions in patients? B: Does Canakinumab prevent the need of further treatment with IVIG and/or corticosteroids?;Primary end point(s): The proportion of patients which show resolution of fever;Timepoint(s) of evaluation of this end point: Fever after 48 hrs of Canakinumab	—

Measure

Time frame

Main Objective: Efficacy, tolerability and saftey of Canakinumab in Kawasaki Disease . The primary objective of this study is to evaluate the proportion of patients which show resolution of fever?;Secondary Objective: A: Does Canakinumab reduce the incidence of coronary artery lesions in patients? B: Does Canakinumab prevent the need of further treatment with IVIG and/or corticosteroids?;Primary end point(s): The proportion of patients which show resolution of fever;Timepoint(s) of evaluation of this end point: Fever after 48 hrs of Canakinumab

—

Secondary

Measure	Time frame
Secondary end point(s): proprtion of coronary artery lesions at 2, 6 and 12 months after Canakinumab;Timepoint(s) of evaluation of this end point: Duration of trial	—

Countries

Netherlands

Contacts

Public ContactProfessor of Pediatric Immunology

Amsterdam University Medical Center

t.w.kuijpers@amsterdamumc.nl+31205662727

Outcome results

None listed

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