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ABBV-383

Phase 1

Immunoglobulin Light Chain (AL) Amyloidosis | Small molecule | Rare Disease |AbbVie Inc.|Last Updated: May 13, 2026

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Trial Design
CONTROLLED
Total Trials1
Total Enrollment76
FDA Designations
No designations recorded
Clinical trial landscape

ABBV-383 · 1 trial · 1 indication

Phase 1 1
NCT06158854A 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) InfusionImmunoglobulin Light Chain (AL) Amyloidosis
RECRUITING76 Analytics
PHASE1RECRUITING
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) AmyloidosisUnlock trial analytics
Study Endpoints
Primary Endpoints
Dose Escalation Only: Number of Participants with Dose-Limiting Toxicities (DLT)
Up to 28 Days

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.

Dose Expansion Only: Percentage of Participants who Achieve Hematologic Complete Response (CR)
Up to 4 years

Hematologic CR is defined as the percentage of participants who achieve normalization of free light chain levels, negative serum immunofixation, negative urine immunofixation as determined per the modified International Amyloidosis Consensus Criteria (IACC).

Dose Expansion Only: Number of Participants with DLTs
Up to 4 years

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.

Number of Participants with Adverse Events (AEs)
Up to 4 years

An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Secondary Endpoints
Hematologic Overall Response Rate (ORR)
Up to 4 Years
Time to Hematologic CR
Up to 4 Years
Duration of Hematologic CR
Up to 4 Years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Escalation: ABBV-383 (etentamig) Dose AEXPERIMENTALParticipants will receive ABBV-383 (etentamig) dose A during the approximately 2 year study duration.
Dose Escalation: ABBV-383 (etentamig) Dose BEXPERIMENTALParticipants will receive ABBV-383 (etentamig) dose B during the approximately 2 year study duration.
Dose Escalation: ABBV-383 (etentamig) Dose CEXPERIMENTALParticipants will receive ABBV-383 (etentamig) dose C during the approximately 2 year study duration.
Dose Expansion: ABBV-383 (etentamig)EXPERIMENTALParticipants will receive ABBV-383 (etentamig) expansion dose B during the approximately 2 year study duration.
Interventions
NameTypeDescription
ABBV-383 (Etentamig)DRUGIntravenous Infusion
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Diagnosis of primary systemic immunoglobulin light chain (AL) amyloidosis. * Eastern Cooperative Oncology Group (ECOG) performance status of \<= 2. * Have at least 1 organ historically impacted by AL amyloidosis. * Considered AL amyloidosis cardiac risk stage 1, 2, or 3a, or c...

Countries:United StatesAustraliaFranceGreeceItalyJapan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06158854primaryCompletionDate: changed
LOWMay 24, 2026NCT06158854studyFirstPostDate: changed