Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04697069
Status:
TERMINATED
Last Update Posted:
2023-01-09
First Post:
2020-12-23
Brief Title:
A Study to Evaluate of the Efficacy and Safety of Imsidolimab ANB019 in the Treatment of Acneiform Rash
Sponsor:
AnaptysBio Inc
Organization:
AnaptysBio Inc
Study Overview
Official Title:
A Phase 2a Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Acneiform Rash in Subjects With Neoplasm Receiving EGFRi or MEKi Therapy
Status:
TERMINATED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administrative Reason
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Efficacy and Safety of imsidolimab in participants with epidermal growth factor receptor inhibitor EGFRimitogen-activated protein MAPextracellular signal-regulated kinase ERK kinase inhibitor MEKi-associated acneiform Rash
Detailed Description:
This study is a Phase 2a multicenter randomized double-blind placebo-controlled study to evaluate the efficacy safety and tolerability of imsidolimab compared with placebo in cancer participants with EGFRiMEKi-associated acneiform rash This study will also characterize the pharmacokinetic PK profile of imsidolimab and explore the immune response to imsidolimab in participants with EGFRiMEKi-associated acneiform rash
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 |
|---|---|---|---|
| 2020-003494-22 | EUDRACT_NUMBER | None | None |