Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640517
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Study of the Efficacy Safety Pharmacokinetics and Immunogenicity of Netakimab in Children with Moderate to Severe Plaque Psoriasis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study of the Efficacy Safety Pharmacokinetics and Immunogenicity of Netakimab in Children with Moderate to Severe Plaque Psoriasis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLANETA-KIDS
Brief Summary:
The aim of the study is to evaluate the efficacy and safety of netakimab compared with placebo in a pediatric population of subjects over 6 years of age with moderate to severe plaque psoriasis The study will have randomized double-blind placebo-controlled study with open-arm comparison
Detailed Description:
Following screening subjects will be randomized to receive either netakimab placebo or adalimumab in a 212 ratio and enter the main study period
During the main study period subjects will receive therapy with netakimabplacebo double-blind arms or adalimumab open-label arm which will be administered subcutaneously until week 12
At Week 12 after completion of all scheduled procedures subjects in groups netakimabplacebo will continue to receive open-label netakimab for up to week 58 subjects in group adalimumab will switch to open-label adalimumab after 8-week washout period
At Week 58 after completion of all scheduled procedures subjects with sPGA 1 will be re-randomised to recieve either netakimab or placebo in double-blind maner The subjects with 1 will continue to recieve open-label netakimab
During the main study period subjects will receive therapy with netakimabplacebo double-blind arms or adalimumab open-label arm which will be administered subcutaneously until week 12
At Week 12 after completion of all scheduled procedures subjects in groups netakimabplacebo will continue to receive open-label netakimab for up to week 58 subjects in group adalimumab will switch to open-label adalimumab after 8-week washout period
At Week 58 after completion of all scheduled procedures subjects with sPGA 1 will be re-randomised to recieve either netakimab or placebo in double-blind maner The subjects with 1 will continue to recieve open-label netakimab
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None