Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06307613
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-03-06
Brief Title:
A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults with Thyroid Eye Disease
Sponsor:
argenx
Organization:
argenx
Study Overview
Official Title:
A Phase 3 Randomized Double-Masked Placebo-Controlled Multicenter Study to Evaluate the Efficacy Safety Tolerability Pharmacokinetics Pharmacodynamics and Immunogenicity of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants with Thyroid Eye Disease
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:
UplighTED
Brief Summary:
This study aims to evaluate the efficacy safety and tolerability pharmacokinetics PK pharmacodynamics PD and immunogenicity of efgartigimod PH20 SC in participants with active moderate-to-severe TED compared with placebo PH20 SC
After the screening period eligible participants will be randomized in a 21 ratio to receive efgartigimod PH20 SC or placebo PH20 SC respectively during the double-blinded treatment period DBTP At the end of the DBTP participants may enter a follow-up observational period while off study drug Some participants may also enter the open-label treatment period with efgartigimod PH20 SC The study duration varies from approximately 60 to 110 weeks
An alternative list of clinical sites open for recruitment could be found in the other UplighTED study record httpswwwclinicaltrialsgovstudyNCT06307626
After the screening period eligible participants will be randomized in a 21 ratio to receive efgartigimod PH20 SC or placebo PH20 SC respectively during the double-blinded treatment period DBTP At the end of the DBTP participants may enter a follow-up observational period while off study drug Some participants may also enter the open-label treatment period with efgartigimod PH20 SC The study duration varies from approximately 60 to 110 weeks
An alternative list of clinical sites open for recruitment could be found in the other UplighTED study record httpswwwclinicaltrialsgovstudyNCT06307626
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 |
|---|---|---|---|
| 2023-509197-35-00 | CTIS | None | None |