Ignite Creation Date:
2024-05-06 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03504852
Status:
COMPLETED
Last Update Posted:
2021-10-11
First Post:
2018-03-29
Brief Title:
Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With ModerateSevere Chronic Plaque Psoriasis
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Double-blind Multicenter Study Assessing Short and Long-term Efficacy Safety and Tolerability of Sub-cutaneous Secukinumab in Subjects of Body Weight 90 kg or Higher With Moderate to Severe Chronic Plaque-type Psoriasis
Status:
COMPLETED
Status Verified Date:
2021-10
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:
The purpose of this study is to assess secukinumab high dose every 2 weeks vs standard dose every 4 weeks in heavy body weight subjects with moderate to severe plaque psoriasis
Detailed Description:
A 52-week multicenter randomized double-blind parallel-group trial in 331 subjects with moderate to severe chronic plaque-type psoriasis of body weight 90 kg or higher at time of randomization
This study consisted of 4 periods screening up to 4 weeks treatment Period 1 16 weeks treatment Period 2 36 weeks and post-treatment follow-up 8 weeks
Subjects were randomized using a 11 ratio to the following groups Secukinumab 300 mg every 2 weeks Secukinumab 300 mg every 4 weeks
In addition subjects from the 300 mg every 4 weeks group who did not achieve Psoriasis Area Severity Index PASI 90 response at Week 16 were reassigned using a 11 ratio to either remain on secukinumab 300 mg every 4 weeks or receive secukinumab 300 mg every 2 weeks starting at Week 16 until the end of treatment
This study consisted of 4 periods screening up to 4 weeks treatment Period 1 16 weeks treatment Period 2 36 weeks and post-treatment follow-up 8 weeks
Subjects were randomized using a 11 ratio to the following groups Secukinumab 300 mg every 2 weeks Secukinumab 300 mg every 4 weeks
In addition subjects from the 300 mg every 4 weeks group who did not achieve Psoriasis Area Severity Index PASI 90 response at Week 16 were reassigned using a 11 ratio to either remain on secukinumab 300 mg every 4 weeks or receive secukinumab 300 mg every 2 weeks starting at Week 16 until the end of treatment
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 |
|---|---|---|---|
| 2015-004620-60 | EUDRACT_NUMBER | None | None |