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NCT06158854 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Immunoglobulin Light Chain (AL) Amyloidosis Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion
A Phase 1 study of Immunoglobulin Light Chain (AL) Amyloidosis, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
- 20
- Study locations
NCT06158854: Recruiting Phase 1 study of Immunoglobulin Light Chain (AL) Amyloidosis, sponsored by AbbVie.
NCT06158854 is a Phase 1 study of Immunoglobulin Light Chain (AL) Amyloidosis that is actively recruiting participants, run by AbbVie. The registered enrollment target is 76 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06158854, a Phase 1 study of Immunoglobulin Light Chain (AL) Amyloidosis, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
- 20
- Study locations
Study 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. Etentamig (ABBV-383) is an investigational drug being developed for the treatment of AL amyloidosis. This study in broken into 2 parts (dose escalation and dose expansion) with 4 arms. During dose escalation (arms 1-3) participants will receive 1 of 3 doses of ABBV-383 to determine the part 2 dose. After completion of the dose escalation portion of the study, the dose expansion (part 2) portion of the study will begin. One arm (arm 4) will begin and participants will receive a dose determined during the dose escalation portion (part 1). Around 76 adult participants with relapsed/refractory AL amyloidosis will be enrolled at approximately 25 sites across the world. Participants will receive Etentamig (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.
Primary Outcome
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Conditions Studied
Interventions
- DRUG ABBV-383 (Etentamig)
Study Locations (20)
New York
- Icahn School of Medicine at Mount Sinai /ID# 255408 - New York
- Columbia University Medical Center /ID# 255068 - New York
- Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255073 - New York
North Carolina
- Atrium Health Levine Cancer Institute /ID# 255074 - Charlotte
- Atrium Health Wake Forest Baptist Medical Center /ID# 255851 - Winston-Salem
Florida
- Sylvester Comprehensive Cancer Center - University of Miami /ID# 255856 - Miami
Massachusetts
- Boston Medical Center /ID# 255066 - Boston
Minnesota
- Mayo Clinic - Rochester /ID# 255258 - Rochester
Oregon
- Oregon Medical Research Center /ID# 255119 - Portland
Washington
- University of Washington /ID# 261581 - Seattle
Wisconsin
- Wisconsin Medical Center /ID# 255836 - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2031-09 |
| Phase | Phase 1 |
What NCT06158854 shows while recruiting
NCT06158854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher).
The record links to 1 condition, with Immunoglobulin Light Chain (AL) Amyloidosis appearing as the primary indexed condition, and to 1 intervention - of which ABBV-383 (Etentamig) is the first listed.
NCT06158854 names 20 study sites across 17 states, led by New York, North Carolina, Florida.
Frequently Asked Questions
What is clinical trial NCT06158854 about?
NCT06158854 is a clinical study titled "A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Immunoglobulin Light Chain (AL) Amyloidosis Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion". 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 ac...
What is the current status of trial NCT06158854?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2024-04-01. Estimated completion is 2031-09.
What conditions does trial NCT06158854 study?
This clinical trial studies the following conditions: Immunoglobulin Light Chain (AL) Amyloidosis.
What interventions are being tested in trial NCT06158854?
The interventions under investigation include: ABBV-383 (Etentamig) (DRUG).
Who is sponsoring clinical trial NCT06158854?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06158854 being conducted?
This trial has 20 study locations across Florida, Massachusetts, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06158854's enrollment target sits among peer trials
76 705th of 2000 higher than 1,290 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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