Ignite Creation Date:
2024-05-06 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05267600
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2022-02-14
Brief Title:
A Phase 23 Study of Efgartigimod PH20 SC in Adult Participants with Bullous Pemphigoid
Sponsor:
argenx
Organization:
argenx
Study Overview
Official Title:
A Phase 23 Randomized Double-Blinded Placebo-Controlled Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants with Bullous Pemphigoid
Status:
COMPLETED
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:
BALLAD
Brief Summary:
ARGX-113-2009 is an operationally seamless 2-part phase 23 prospective global multicenter randomized double-blinded placebo-controlled study to investigate the efficacy safety tolerability immunogenicity participant-reported outcome measures including those assessing participant QoL PK and PD of efgartigimod PH20 SC administered via subcutaneous SC injection in adult participants with moderate to severe BP This study intends to demonstrate that efgartigimod is an effective and safe treatment for BP providing participants with control of disease activity CDA and eventually remission while reducing their cumulative exposure to OCS
study will consist of 2 parts
Part A of the study is a phase 2 evaluation that intends to provide proof of concept for the therapeutic activity of efgartigimod PH20 SC in participants with BP
Part B of the study is a phase 3 evaluation that intends to confirm the results obtained from part A in a separate larger group of participants with BP
An interim analysis will be performed during part A on data obtained through week 26 for all Part A participants to assess the primary endpoint and several secondary endpoints confirm the appropriate sample size for part B of the study and determine whether the efficacy results observed through week 26 of part A warrant continued study of efgartigimod PH20 SC for the treatment of participants with BP futility analysis
Other than differences in main goals endpoints and statistical analyses parts A and B are identical in schedule structure assessments and conduct
study will consist of 2 parts
Part A of the study is a phase 2 evaluation that intends to provide proof of concept for the therapeutic activity of efgartigimod PH20 SC in participants with BP
Part B of the study is a phase 3 evaluation that intends to confirm the results obtained from part A in a separate larger group of participants with BP
An interim analysis will be performed during part A on data obtained through week 26 for all Part A participants to assess the primary endpoint and several secondary endpoints confirm the appropriate sample size for part B of the study and determine whether the efficacy results observed through week 26 of part A warrant continued study of efgartigimod PH20 SC for the treatment of participants with BP futility analysis
Other than differences in main goals endpoints and statistical analyses parts A and B are identical in schedule structure assessments and conduct
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?:
False
Is an FDA AA801 Violation?:
None