Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655155
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults with Systemic Sclerosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Blinded Placebo-Controlled Phase 2 Parallel-Group Study to Evaluate the Efficacy Safety Tolerability Pharmacodynamics Pharmacokinetics and Immunogenicity of Efgartigimod PH20 SC in Adult Participants with Systemic Sclerosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
eSScape
Brief Summary:
The main purpose of this study is to evaluate the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis The study consists of a screening period a treatment period of up to 48 weeks and a safety follow-up period After the screening period eligible participants will be randomized in a 21 ratio to receive either efgartigimod PH20 SC or placebo The total study duration can be up to approximately 15 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None