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

Phase 1

• Conditions: Active Kawasaki disease; MedDRA version: 19.1Level: PTClassification code 10023320Term: Kawasaki's diseaseSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-003763-11-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-07
• Last Update Posted: 13 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 26

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
;
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
;
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

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
;
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
;
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified