A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis
NCT ID: NCT05721573
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
231 participants
INTERVENTIONAL
2023-02-28
2026-01-31
Brief Summary
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Detailed Description
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The study will include a sentinel cohort (Part A) of 30 subjects who will receive first three doses of the study drug. Safety data from subjects in the sentinel cohorts will be evaluated by a Data and Safety Monitoring Board (DSMB) before further dosing of the sentinel cohort, as well as initiation of enrollment in the double-blind safety and efficacy cohort (Part B). After completion of Part A or Part B, subjects have the option of enrolling in an open-label long-term extension study or progressing to the pharmacodynamics (PD) recovery cohort (Part C), to evaluate the recovery of the depletion of killer cell lectin-like receptor G1 (KLRG1)+ cells after the end of treatment with ABC008.
Efficacy, safety, HRQoL, and HRU assessments will be conducted. Blood samples will be obtained to evaluate the serum PK, PD, and immunogenicity of ABC008 throughout the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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0.5 mg/kg ABC008
Part A - ABC008 N=12
Part B - ABC008 N= 67
ABC008
Given by subcutaneous injection
2.0 mg/kg ABC008
Part A - ABC008 N=12
Part B - ABC008 N= 67
ABC008
Given by subcutaneous injection
Placebo
Part A - Placebo N= 6
Part B - Placebo N= 67
ABC008
Given by subcutaneous injection
Interventions
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ABC008
Given by subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* 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 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;
40 Years
ALL
No
Sponsors
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Syneos Health
OTHER
Abcuro, Inc.
INDUSTRY
Responsible Party
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Locations
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Neuromuscular Research Center
Phoenix, Arizona, United States
University of California Irvine Medical Center (UCIMC) - Amyotrophic Lateral Sclerosis (ALS) and Neuromuscular Center
Irvine, California, United States
Keck Hosptial of USC
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Stanford Neuroscience Medical Center
Palo Alto, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado Hospital Anschutz Outpatient Pavillion
Aurora, Colorado, United States
Yale School of Medicine
New Haven, Connecticut, United States
Mayo Clinic
Jacksonville, Florida, United States
Northwestern Memorial Hospital, Department of Neurology (Clinic)
Chicago, Illinois, United States
University of Kansas Medical
Kansas City, Kansas, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Neuromuscular Diagnostic Center - Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Hospital for Special Surgery
New York, New York, United States
Columbia University Medical Center / The Neurological Institute of New York
New York, New York, United States
Duke Neurological Disorders Clinic -1L
Durham, North Carolina, United States
Wake Forrest School of Medicine
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC Arthritis and Autoimmunity Center, Falk Clinic
Pittsburgh, Pennsylvania, United States
Austin Neuromuscular Center
Austin, Texas, United States
Texas Neurology
Dallas, Texas, United States
Nerve and Muscle Center of Texas
Houston, Texas, United States
Virginia Commonwealth University
Henrico, Virginia, United States
University of Washington Medical Center - Montlake
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Perron Institute for Neurological and Translational Science
Nedlands, Western Australia, Australia
AZ Sint-Lucas & Volkskliniek
Ghent, , Belgium
Heritage Medical Research Clinic - University of Calgary
Calgary, Alberta, Canada
Genge Partners Inc.
Montreal, Quebec, Canada
Hospital Pitie-Salpetriere - AP-HP
Paris, , France
Krankenhaus und Poliklinik Rüdersdorf GmbH
Berlin, , Germany
University Hosptial Duesseldorf
Düsseldorf, , Germany
University College London Hospitals NHS Foundation Trust, National Hospital for Neurology and Neurosurgery (NHNN)
London, , United Kingdom
Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
Salford, , United Kingdom
Countries
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Related Links
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Study Website
Other Identifiers
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ABC008-IBM-201
Identifier Type: -
Identifier Source: org_study_id