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New drug ABC008 shows promise in slowing rare muscle disease

NCT ID NCT05721573

Disease control Sponsor: Abcuro, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug, ABC008, in 272 adults with inclusion body myositis, a rare muscle-weakening disease. The goal was to see if the drug is safe and can help slow the disease's progression. Participants received either ABC008 or a placebo, and their muscle function was tracked over 76 weeks.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

272 people

The number who actually took part.

Started

Feb 2023

Finished

Nov 2025

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

40 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: * Adult males and females age \>40 years at the time of the first dose of study medication; * Weight \>40 and \<150 kg; * Diagnosis of either clinico-pathologically defined IBM, clinically defined IBM, or probable IBM according to the European Neuromuscular Centre (ENMC) IBM 2011 research diagnostic criteria (Rose et al., 2013). Documented histopathology results must be available prior to Baseline (Day 1) to confirm eligibility; * Able to arise from a chair (with armrests), with use of their arms but without support from another person or device (e.g., cane, walking stick), at Screening and Baseline (Day 1); * Able to walk 3 meters, turn around, walk back to the chair, and sit down, with or without assistive device. Once arisen from the chair, subject may use any walking device but cannot be supported by another person, furniture, or a wall; Exclusion Criteria: * Any other form of myositis or myopathy other than IBM, e.g., metabolic or drug-induced myopathy, drug-induced myositis, anti-synthetase syndrome, polymyositis or dermatomyositis, cancer-associated myositis (myositis diagnosed within 3 years, either before or after), myositis in overlap with another autoimmune disease (e.g., systemic lupus, systemic sclerosis, rheumatoid arthritis), or muscular dystrophy; * Any condition, e.g., severe degenerative arthritis with limited range of motion, which precludes the ability to quantitate muscle strength or perform functional assessments (e.g., mTUG), in the Investigator's opinion;. * Presence of another autoimmune or autoinflammatory disease other than indication under study, e.g., rheumatoid arthritis, psoriatic arthritis, axial spondyloarthropathy, inflammatory bowel disease, systemic lupus erythematosus. Subjects with Sjogren's syndrome, T-cell large granular lymphocyte leukemia (T-LGLL), or well-controlled thyroid disease are permitted;

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Conditions

The condition(s) this trial relates to.

inclusion body myositis muscle tissue disorder myositis disease nervous system disorder neuromuscular disease

As listed by the trial registrant

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

Inclusion body myositis

Contacts and locations

Locations

  • AZ Sint-Lucas & Volkskliniek

    Ghent, 9000, Belgium

  • Austin Neuromuscular Center

    Austin, Texas, 78759, United States

  • Brigham and Womens Hospital

    Boston, Massachusetts, 021158, United States

  • Columbia University Medical Center / The Neurological Institute of New York

    New York, New York, 10032, United States

  • Duke Neurological Disorders Clinic -1L

    Durham, North Carolina, 27710, United States

  • Genge Partners Inc.

    Montreal, Quebec, H4A 3T2, Canada

  • Heritage Medical Research Clinic - University of Calgary

    Calgary, Alberta, 3M 1M4, Canada

  • Hospital Pitie-Salpetriere - AP-HP

    Paris, 75013, France

  • Hospital for Special Surgery

    New York, New York, 10021, United States

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224, United States

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287, United States

  • Keck Hosptial of USC

    Los Angeles, California, 90033, United States

  • Krankenhaus und Poliklinik Rüdersdorf GmbH

    Berlin, 15562, Germany

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Nerve and Muscle Center of Texas

    Houston, Texas, 77030, United States

  • Neuromuscular Diagnostic Center - Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Neuromuscular Research Center

    Phoenix, Arizona, 85028, United States

  • Northwestern Memorial Hospital, Department of Neurology (Clinic)

    Chicago, Illinois, 60611, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Perron Institute for Neurological and Translational Science

    Nedlands, Western Australia, 6009, Australia

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4006, Australia

  • Royal North Shore Hospital

    Saint Leonards, New South Wales, 2065, Australia

  • Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust

    Salford, M6 8HD, United Kingdom

  • Stanford Neuroscience Medical Center

    Palo Alto, California, 94304, United States

  • Texas Neurology

    Dallas, Texas, 75206, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • UCLA Medical Center

    Los Angeles, California, 90095, United States

  • UPMC Arthritis and Autoimmunity Center, Falk Clinic

    Pittsburgh, Pennsylvania, 15213, United States

  • University College London Hospitals NHS Foundation Trust, National Hospital for Neurology and Neurosurgery (NHNN)

    London, WC1N 3BG, United Kingdom

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University Hosptial Duesseldorf

    Düsseldorf, 40225, Germany

  • University of California Irvine Medical Center (UCIMC) - Amyotrophic Lateral Sclerosis (ALS) and Neuromuscular Center

    Irvine, California, 92868, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Colorado Hospital Anschutz Outpatient Pavillion

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical

    Kansas City, Kansas, 66160, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 98198, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195, United States

  • Virginia Commonwealth University

    Henrico, Virginia, 23233, United States

  • Wake Forrest School of Medicine

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Yale School of Medicine

    New Haven, Connecticut, 06519, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.