Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06015737
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-08-01
Brief Title:
A 2-stage Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic andor Subacute Cutaneous Lupus Erythematosus
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Multicenter Randomized Double Blind Placebo Controlled Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults With Chronic andor Subacute Cutaneous Lupus Erythematosus Who Are Refractory andor Intolerant to Antimalarial Therapy
Status:
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:
LAVENDER
Brief Summary:
This study aims to evaluate the efficacy and safety of subcutaneous SC anifrolumab versus placebo in adult participants with cutaneous lupus erythematosus CLE
Detailed Description:
The primary objectives of the study are to evaluate the efficacy of anifrolumab compared with placebo in reducing skin disease in participants with active chronic andor subacute CLE who are refractory andor intolerant to antimalarial therapy The secondary objectives of the study are to evaluate additional efficacy parameters of anifrolumab safety tolerability quality of life pharmacokinetics pharmacodynamics and immunogenicity Stage 1 and Stage 2 of the study will have broadly identical study designs with the exception of sample size Both Stages of the study will have a randomized double-blind placebo-controlled design followed by an open-label treatment period
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 |
|---|---|---|---|
| 2021-003698-70 | EUDRACT_NUMBER | None | None |