Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05899816
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2023-06-02
Brief Title:
A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis AD ROCKET - VOYAGER
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 3 24-week Randomized Placebo-controlled Double-blind Study to Assess the Effect of Rocatinlimab on Vaccine Antibody Response in Adult Subjects With Moderate-to-severe Atopic Dermatitis AD ROCKET - VOYAGER
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
ROCKET-VOYAGER
Brief Summary:
The primary objectives of this study are to
estimate vaccine response in rocatinlimab group vs placebo group assessed using antibody anti-tetanus response at Week 24
estimate vaccine response in rocatinlimab group vs placebo group assessed using antibody anti-meningococcal response at Week 24
estimate vaccine response in rocatinlimab group vs placebo group assessed using antibody anti-tetanus response at Week 24
estimate vaccine response in rocatinlimab group vs placebo group assessed using antibody anti-meningococcal response at Week 24
Detailed Description:
None
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