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Monoclonal Antibodies

ABBV-383 for Amyloidosis

Phase 1 & 2
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
Has previously been exposed to a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the effects of a new drug, ABBV-383, on adults with AL amyloidosis. AL amyloidosis is a condition where the body produces too much of a

Who is the study for?
This trial is for adults with AL amyloidosis, a condition where abnormal proteins build up in organs. Participants must have had prior treatments including proteasome inhibitors and anti-CD38 antibodies, be moderately healthy (ECOG <=2), and have measurable disease impact on at least one organ.
What is being tested?
The study tests ABBV-383, an experimental drug for AL amyloidosis. It has two parts: first to find the right dose and second to assess safety at selected doses. Patients receive the drug through IV over approximately two years across various global sites.
What are the potential side effects?
Specific side effects of ABBV-383 are not listed but monitoring includes medical assessments, blood tests, checking for side effects, and questionnaires which suggest potential common infusion-related reactions or impacts on organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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I have been treated with drugs targeting proteins and CD38 before.
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I have been diagnosed with AL amyloidosis.
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My AL amyloidosis has affected at least one of my organs.
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My AL amyloidosis is stage 1, 2, or 3a with measurable disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Dose-Limiting Toxicities (DLT)
Secondary study objectives
Duration of Hematologic CR
Organ Response Rate (OrRR)
Overall Hematologic Response (OHR)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Safety Expansion: ABBV-383 Expansion BExperimental Treatment1 Intervention
Participants will receive ABBV-383 expansion dose B during the approximately 2 year study duration.
Group II: Safety Expansion: ABBV-383 Expansion AExperimental Treatment1 Intervention
Participants will receive ABBV-383 expansion dose A during the approximately 2 year study duration.
Group III: Dose Escalation: ABBV-383 Dose CExperimental Treatment1 Intervention
Participants will receive ABBV-383 dose C during the approximately 2 year study duration.
Group IV: Dose Escalation: ABBV-383 Dose BExperimental Treatment1 Intervention
Participants will receive ABBV-383 dose B during the approximately 2 year study duration.
Group V: Dose Escalation: ABBV-383 Dose AExperimental Treatment1 Intervention
Participants will receive ABBV-383 dose A during the approximately 2 year study duration.

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,029 Previous Clinical Trials
521,454 Total Patients Enrolled
1 Trials studying AL Amyloidosis
46 Patients Enrolled for AL Amyloidosis
ABBVIE INC.Study DirectorAbbVie
450 Previous Clinical Trials
161,940 Total Patients Enrolled
~46 spots leftby Dec 2025
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