Ignite Creation Date:
2024-05-06 @ 12:17 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03721172
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2018-10-09
Brief Title:
Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo an Analysis of Clinical Safety and Efficacy
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Placebo-Controlled Double-Blind Study of the Efficacy and Safety of Apremilast CC-10004 in Subjects With Mild to Moderate Plaque Psoriasis
Status:
COMPLETED
Status Verified Date:
2024-05
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:
ADVANCE
Brief Summary:
This is a Phase 3 multicenter randomized placebo-controlled double-blind study designed to evaluate the efficacy and safety of apremilast CC-10004 in subjects with mild to moderate plaque psoriasis
Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 11 to receive either apremilast 30 mg BID or placebo for the first 16 weeks
Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 11 to receive either apremilast 30 mg 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 be randomly assigned to either 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 will be switched to or continue with apremilast 30 mg BID All subjects will maintain this dosing through Week 32
Observational Follow-up Phase - 4 weeks - Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue the study early
Screening Phase - up to 35 days
Double-blind Placebo-controlled Phase - Weeks 0 to 16
- Subjects will be randomly assigned to either 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 will be switched to or continue with apremilast 30 mg BID All subjects will maintain this dosing through Week 32
Observational Follow-up Phase - 4 weeks - Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue 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 |
|---|---|---|---|
| U1111-1218-8372 | REGISTRY | WHO | None |