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New drug targets rare protein disease in early trial

NCT ID NCT06158854

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests an experimental drug called etentamig (ABBV-383) in adults with AL amyloidosis, a rare disease where abnormal proteins build up in organs. About 76 participants will receive the drug by infusion to see if it is safe and can control the disease. The trial has two parts to find the best dose and measure response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Etentamig (ABBV-383)
What this could lead to
If it works, this could provide a new treatment option to control AL amyloidosis by reducing harmful protein buildup.
What could go wrong
This is an early-phase trial with small numbers, so results may not apply broadly. Side effects are unknown and could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Aug 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 considered risk stage 3b with stable cardiac function and markers for 3 months prior to dosing, and have measurable disease of AL amyloidosis as defined by difference between involved and uninvolved free light chains (dFLC) \>= 50 mg/L or meeting high-risk dFLC progression criteria after immediate prior line of therapy. * Has previously been exposed to a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody. Exclusion Criteria: * Known history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months. * Known allergic reaction, significant sensitivity, or intolerance to constituents of the study treatment (and excipients) and/or other products in the same class. * Participant has the following conditions: * Other non-AL amyloid disease; * Previous or current diagnosis of symptomatic multiple myeloma (MM), including the presence of lytic bone disease, plasmacytomas, \>= 60% plasma cells in the bone marrow, or hypercalcemia (defined as corrected calcium \> 11 mg/dL); * Active plasma cell leukemia (i.e., either 20% of peripheral white blood cells or \> 2.0 × 109/L circulating plasma cells by standard differential); * Waldenström's macroglobulinemia; * Acute diffuse infiltrative pneumopathy; * Major surgery within 28 days prior first dose or planned during study participation; * History of organ transplant requiring continued use of immunosuppressants; * Acute infections within 14 days prior first dose requiring parenteral therapy (antibiotic, antifungal, or antiviral); * Participant has received an autologous stem cell transplant (SCT) within 12 weeks or an allogeneic SCT within 1 year of the first dose of study treatments.

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Conditions

The condition(s) this trial relates to.

AL amyloidosis amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immunoglobulin light chain (AL) amyloidosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alexandra General Hospital /ID# 255542

    RECRUITING

    Athens, Attica, 11528, Greece

  • Atrium Health Levine Cancer Institute /ID# 255074

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Atrium Health Wake Forest Baptist Medical Center /ID# 255851

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Boston Medical Center /ID# 255066

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Box Hill Hospital /ID# 255199

    RECRUITING

    Box Hill, Victoria, 3128, Australia

  • CHU Limoges - Dupuytren 1 /ID# 255370

    RECRUITING

    Limoges, Franche-Comte, 87042, France

  • CHU Toulouse - Hopital Rangueil /ID# 255377

    RECRUITING

    Toulouse, Haute-Garonne, 31400, France

  • Columbia University Medical Center /ID# 255068

    RECRUITING

    New York, New York, 10032-3729, United States

  • Fondazione IRCCS Policlinico San Matteo /ID# 255655

    RECRUITING

    Pavia, 27100, Italy

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255654

    RECRUITING

    Bologna, 40138, Italy

  • Icahn School of Medicine at Mount Sinai /ID# 255408

    RECRUITING

    New York, New York, 10029, United States

  • Japanese Red Cross Medical Center /ID# 256083

    RECRUITING

    Shibuya-ku, Tokyo, 150-8935, Japan

  • Kumamoto University Hospital /ID# 262579

    RECRUITING

    Kumamoto, Kumamoto, 8608556, Japan

  • Mayo Clinic - Rochester /ID# 255258

    RECRUITING

    Rochester, Minnesota, 55905-0001, United States

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255073

    RECRUITING

    New York, New York, 10065-6007, United States

  • Nagoya City University Hospital /ID# 256086

    RECRUITING

    Nagoya, Aichi-ken, 467-8602, Japan

  • Oregon Medical Research Center /ID# 255119

    RECRUITING

    Portland, Oregon, 97239, United States

  • Princess Alexandra Hospital /ID# 255202

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Sylvester Comprehensive Cancer Center - University of Miami /ID# 255856

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Washington /ID# 261581

    RECRUITING

    Seattle, Washington, 98109, United States

  • Vanderbilt University Medical Center. /ID# 273510

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Westmead Hospital /ID# 255200

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Wisconsin Medical Center /ID# 255836

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States