Ignite Creation Date:
2024-05-06 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03668613
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2018-08-23
Brief Title:
Study to Assess the Long-term Safety Tolerability Efficacy of Secukinumab in Pediatric Patients of Age 6 to 18 Years With Moderate to Severe Plaque Psoriasis
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Open-label Multicenter Trial to Assess the Efficacy of Subcutaneous Secukinumab after12 Weeks of Treatment and to Assess the Long-term Safety Tolerability Efficacy in Subjects From 6 to 18 Years of Age With Moderate to Severe Chronic Plaque Psoriasis
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was an open-label parallel-group two-arm multicenter study in pediatric subjects aged 6 years to less than 18 years at randomization with moderate to severe chronic plaque psoriasis 84 subjects most with moderate severity were enrolled Subjects were stratified by weight and disease severity
Detailed Description:
This was an open-label parallel group two-arm multi-center trial in pediatric subjects aged 6 years to less than 18 years at randomization with moderate to severe chronic plaque psoriasis The study consists of 3 periods screening up to 4 weeks treatment Week 208 and post-treatment follow-up Week 224
Approximately 80 subjects at least 60 subjects with moderate psoriasis were planned to be enrolled in about 40 centers worldwide and targeted to have at least 5 subjects in the 25kg body weight and at least 10 subjects in each of the other two weight groups 25- 50 kg and 50 kg Adolescents 12- 18 years and children 6- 12 years were included from the beginning of this study since the DMC had approved already the enrollment of children 6- 12 years in the study CAIN457A2310 NCT02471144 Subjects received the appropriate dose based on their body weight category
For the statistical analysis for outcome measures 1 and 2 there was no within study control arm A historical placebo control was obtained using data from qualifying trials and used as the comparator for the primary and key secondary endpoint analysis This was in line with the guidance from and discussions with Health Authorities including FDA and EMA PDCO which suggested reducing placebo exposure as well as overall clinical trial burden for the pediatric population and accepted an extrapolation approach EMA 2012 Historical placebo data included in this study were based on clinical appropriateness and alignment of definitions endpoints clinical disease population and time point of assessment Integrated in the analysis were placebo data from Novartis-reported secukinumab adult placebo-controlled studies CAIN457A2302 NCT01544595 and NCT01365455 CAIN457A2303 NCT01544595 and NCT01358578 CAIN457A2308 NCT01555125 and CAIN457A2309 NCT01636687 and pediatric placebo-controlled study CAIN457A2310 In addition pediatric placebo-controlled study data from the literature on other biologics eg etanercept ustekinumab were utilized Paller et al 2008 Landells et al 2015
If the subject moved into a higher or lower weight group at two consecutive visits with weight measurements during the maintenance from Week 12 onwards as assessed at 4 weekly visits or during extension treatment period as assessed at scheduled site visits then the subject was dosed according to the new higher or lower weight group respectively
Approximately 80 subjects at least 60 subjects with moderate psoriasis were planned to be enrolled in about 40 centers worldwide and targeted to have at least 5 subjects in the 25kg body weight and at least 10 subjects in each of the other two weight groups 25- 50 kg and 50 kg Adolescents 12- 18 years and children 6- 12 years were included from the beginning of this study since the DMC had approved already the enrollment of children 6- 12 years in the study CAIN457A2310 NCT02471144 Subjects received the appropriate dose based on their body weight category
For the statistical analysis for outcome measures 1 and 2 there was no within study control arm A historical placebo control was obtained using data from qualifying trials and used as the comparator for the primary and key secondary endpoint analysis This was in line with the guidance from and discussions with Health Authorities including FDA and EMA PDCO which suggested reducing placebo exposure as well as overall clinical trial burden for the pediatric population and accepted an extrapolation approach EMA 2012 Historical placebo data included in this study were based on clinical appropriateness and alignment of definitions endpoints clinical disease population and time point of assessment Integrated in the analysis were placebo data from Novartis-reported secukinumab adult placebo-controlled studies CAIN457A2302 NCT01544595 and NCT01365455 CAIN457A2303 NCT01544595 and NCT01358578 CAIN457A2308 NCT01555125 and CAIN457A2309 NCT01636687 and pediatric placebo-controlled study CAIN457A2310 In addition pediatric placebo-controlled study data from the literature on other biologics eg etanercept ustekinumab were utilized Paller et al 2008 Landells et al 2015
If the subject moved into a higher or lower weight group at two consecutive visits with weight measurements during the maintenance from Week 12 onwards as assessed at 4 weekly visits or during extension treatment period as assessed at scheduled site visits then the subject was dosed according to the new higher or lower weight group respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-004515-39 | EUDRACT_NUMBER | None | None |