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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
Sponsor: AbbVie
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.
Official title: An Open-Label Phase 1/2 Study Evaluating the Safety and Efficacy of Etentamig (ABBV-383) in AL Amyloidosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2024-04-01
Completion Date
2031-09
Last Updated
2025-12-17
Healthy Volunteers
No
Interventions
ABBV-383 (Etentamig)
Intravenous Infusion
Locations (21)
Sylvester Comprehensive Cancer Center - University of Miami /ID# 255856
Miami, Florida, United States
Boston Medical Center /ID# 255066
Boston, Massachusetts, United States
Mayo Clinic - Rochester /ID# 255258
Rochester, Minnesota, United States
Icahn School of Medicine at Mount Sinai /ID# 255408
New York, New York, United States
Columbia University Medical Center /ID# 255068
New York, New York, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255073
New York, New York, United States
Atrium Health Levine Cancer Institute /ID# 255074
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 255851
Winston-Salem, North Carolina, United States
Oregon Medical Research Center /ID# 255119
Portland, Oregon, United States
University of Washington /ID# 261581
Seattle, Washington, United States
Wisconsin Medical Center /ID# 255836
Milwaukee, Wisconsin, United States
Westmead Hospital /ID# 255200
Westmead, New South Wales, Australia
Princess Alexandra Hospital /ID# 255202
Woolloongabba, Queensland, Australia
Box Hill Hospital /ID# 255199
Box Hill, Victoria, Australia
CHU Limoges - Dupuytren 1 /ID# 255370
Limoges, Franche-Comte, France
CHU Toulouse - Hopital Rangueil /ID# 255377
Toulouse, Haute-Garonne, France
Alexandra General Hospital /ID# 255542
Athens, Attica, Greece
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255654
Bologna, Italy
Nagoya City University Hospital /ID# 256086
Nagoya, Aichi-ken, Japan
Kumamoto University Hospital /ID# 262579
Kumamoto, Kumamoto, Japan
Japanese Red Cross Medical Center /ID# 256083
Shibuya-ku, Tokyo, Japan