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
Public ClinicalTrials.gov record NCT06158854. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label Phase 1/2 Study Evaluating the Safety and Efficacy of Etentamig (ABBV-383) in AL Amyloidosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06158854
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 76 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2024
- Primary completion
- Jan 31, 2028
- Completion
- Jul 31, 2031
- Last update posted
- May 12, 2026
2024 – 2031
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sylvester Comprehensive Cancer Center - University of Miami /ID# 255856 | Miami | Florida | 33136 | Recruiting |
| Boston Medical Center /ID# 255066 | Boston | Massachusetts | 02118 | Recruiting |
| Mayo Clinic - Rochester /ID# 255258 | Rochester | Minnesota | 55905-0001 | Recruiting |
| Icahn School of Medicine at Mount Sinai /ID# 255408 | New York | New York | 10029 | Recruiting |
| Columbia University Medical Center /ID# 255068 | New York | New York | 10032-3729 | Recruiting |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255073 | New York | New York | 10065-6007 | Recruiting |
| Atrium Health Levine Cancer Institute /ID# 255074 | Charlotte | North Carolina | 28204 | Recruiting |
| Atrium Health Wake Forest Baptist Medical Center /ID# 255851 | Winston-Salem | North Carolina | 27157 | Recruiting |
| Oregon Medical Research Center /ID# 255119 | Portland | Oregon | 97239 | Recruiting |
| Vanderbilt University Medical Center. /ID# 273510 | Nashville | Tennessee | 37232 | Recruiting |
| University of Washington /ID# 261581 | Seattle | Washington | 98109 | Recruiting |
| Wisconsin Medical Center /ID# 255836 | Milwaukee | Wisconsin | 53226 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06158854, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 12, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06158854 live on ClinicalTrials.gov.