Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06158854
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-11-28
Brief Title:
A Study to Assess Change in Disease Activity and Adverse Events AEs in Adult Participants With Immunoglobulin Light Chain AL Amyloidosis Receiving ABBV-383 as an Intravenous IV Infusion
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
An Open-Label Phase 1b Study Evaluating the Safety and Efficacy of ABBV-383 in AL Amyloidosis
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
Immunoglobulin light chain AL amyloidosis is the most common form of systemic amyloidosis AL amyloidosis has many root causes and is characterized by the overproduction of AL that are secreted by clonal bone marrow plasma cells This is a study to determine adverse events and change in disease activity in adult participants with AL amyloidosis treated with ABBV-383
ABBV-383 is an investigational drug being developed for the treatment of AL amyloidosis This study in broken into 2 parts dose escalation and safety expansion with 5 arms During dose escalation arms 1-3 participants will receive 1 of 3 doses of ABBV-383 to determine the part 2 doses After completion of the dose escalation portion of the study the safety expansion part 2 portion of the study will begin Two arms arm 4-5 will begin and participants will receive 1 of 2 doses as determined during the dose escalation portion part 1 Around 76 adult participants with relapsedrefractory AL amyloidosis will be enrolled at approximately 20 sites across the world
Participants will receive ABBV-383 as an infusion into the vein for up to approximately 2 year study duration
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and questionnaires
ABBV-383 is an investigational drug being developed for the treatment of AL amyloidosis This study in broken into 2 parts dose escalation and safety expansion with 5 arms During dose escalation arms 1-3 participants will receive 1 of 3 doses of ABBV-383 to determine the part 2 doses After completion of the dose escalation portion of the study the safety expansion part 2 portion of the study will begin Two arms arm 4-5 will begin and participants will receive 1 of 2 doses as determined during the dose escalation portion part 1 Around 76 adult participants with relapsedrefractory AL amyloidosis will be enrolled at approximately 20 sites across the world
Participants will receive ABBV-383 as an infusion into the vein for up to approximately 2 year study duration
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and questionnaires
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-503429-20-00 | OTHER | EU CT | None |