Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05695950
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-01-13
Brief Title:
A Study Evaluating the Effects of GLPG3667 Given As Oral Treatment for Up to 24 Weeks in Adults with Dermatomyositis
Sponsor:
Galapagos NV
Organization:
Galapagos NV
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multi-center Study to Evaluate the Efficacy Safety Tolerability Pharmacokinetics and Pharmacodynamics of Orally Administered GLPG3667 Once Daily for 24 Weeks in Adult Subjects with Dermatomyositis
Status:
RECRUITING
Status Verified Date:
2024-10
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:
GALARISSO
Brief Summary:
The purpose of this study is to evaluate the efficacy safety tolerability pharmacokinetics PK and pharmacodynamics PD of orally administered GLPG3667 once daily for 24 weeks in adult participants with dermatomyositis DM followed by an open-label extension OLE period until Week 48
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-501097-19-00 | CTIS | CTIS - euclinicaltrialseu | None |