Ignite Creation Date:
2024-05-06 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03123471
Status:
COMPLETED
Last Update Posted:
2020-05-13
First Post:
2017-04-18
Brief Title:
A Study of the Efficacy and Safety of Apremilast CC-10004 in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 3 Multi-Center Randomized Placebo-Controlled Double-Blind Study of the Efficacy and Safety of Apremilast CC-10004 in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03740516
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
STYLE
Brief Summary:
This is a Phase 3 multicenter randomized placebo-controlled double-blind study of the efficacy and safety of apremilast CC-10004 in subjects with moderate to severe plaque psoriasis of the scalp
Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 21 to receive either apremilast 30 mg twice daily BID or placebo for the first 16 weeks
Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 21 to receive either apremilast 30 mg twice daily BID or placebo for the first 16 weeks
Detailed Description:
The study will consist of four phases
Screening Phase - up to 35 days
Double-blind Placebo-controlled Phase- Weeks 0 to 16 Subjects will receive treatment with one of the following
apremilast 30 mg tablets orally BID or
placebo tablets identical in appearance to apremilast 30 mg tablets orally BID
Apremilast Extension Phase - Weeks 16 to 32
All subjects who had received placebo during the placebo-controlled phase will be switched to apremilast 30 mg BID or continue with apremilast At Week 16 all subjects will maintain this dosing through Week 32
Observational Follow-up Phase
Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue from the study early
Screening Phase - up to 35 days
Double-blind Placebo-controlled Phase- Weeks 0 to 16 Subjects will receive treatment with one of the following
apremilast 30 mg tablets orally BID or
placebo tablets identical in appearance to apremilast 30 mg tablets orally BID
Apremilast Extension Phase - Weeks 16 to 32
All subjects who had received placebo during the placebo-controlled phase will be switched to apremilast 30 mg BID or continue with apremilast At Week 16 all subjects will maintain this dosing through Week 32
Observational Follow-up Phase
Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue from the study early
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 |
|---|---|---|---|
| U1111-1194-1248 | REGISTRY | WHO | None |