CompletedPhase 2/3
A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis
Key facts
- Who runs it
- Abcuro, Inc.
- Where
- Aurora, Austin, Baltimore, Boston, Chicago, Cleveland, Columbus, Dallas, Durham, Henrico, Hershey, Houston, Irvine, Jacksonville, Kansas City, Los Angeles, Milwaukee, New Haven, New York, Omaha, Palo Alto, Philadelphia, Phoenix, Pittsburgh, Portland, Rochester, San Francisco, Seattle, St Louis, and Winston-Salem, United StatesSee the 34 sitesAlso in 6 other countries, 11 sites
- Trial code
- Status
- Completed
- Phase
- Phase 2/3
- People taking part
- 272 people enrolled
- Started
- 28 Feb 2023
- Ended
- 27 Nov 2025
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- ABC008
- Record updated
- 1 October 2026
Who can take part
- Age
- 40 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in United States
Also in 6 other countries, 11 sites
- University of Colorado Hospital Anschutz Outpatient PavillionAurora, United StatesNo longer taking part
- Austin Neuromuscular CenterAustin, United StatesNo longer taking part
- Johns Hopkins Bayview Medical CenterBaltimore, United StatesNo longer taking part
- Johns Hopkins University School Of MedicineBaltimore, United StatesNo longer taking part
- Brigham and Womens HospitalBoston, United StatesNo longer taking part
- Neuromuscular Diagnostic Center - Massachusetts General HospitalBoston, United StatesNo longer taking part
- Northwestern Memorial Hospital, Department of Neurology (Clinic)Chicago, United StatesNo longer taking part
- University Hospitals Cleveland Medical Center*Cleveland, United StatesNo longer taking part
- The Ohio State University -Wexner Medical CenterColumbus, United StatesNo longer taking part
- Texas NeurologyDallas, United StatesNo longer taking part
- Duke Neurological Disorders Clinic -1LDurham, United StatesNo longer taking part
- Virginia Commonwealth UniversityHenrico, United StatesNo longer taking part
- Penn State Health Milton S. Hershey Medical CenterHershey, United StatesNo longer taking part
- Nerve and Muscle Center of TexasHouston, United StatesNo longer taking part
- University of California Irvine Medical Center (UCIMC) - Amyotrophic Lateral Sclerosis (ALS) and Neuromuscular CenterIrvine, United StatesNo longer taking part
- Mayo ClinicJacksonville, United StatesNo longer taking part
- University of Kansas MedicalKansas City, United StatesNo longer taking part
- Keck Hosptial of USCLos Angeles, United StatesNo longer taking part
- UCLA Medical CenterLos Angeles, United StatesNo longer taking part
- Medical College of WisconsinMilwaukee, United StatesNo longer taking part
- Yale School of MedicineNew Haven, United StatesNo longer taking part
- Columbia University Medical Center The Neurological Institute of New YorkNew York, United StatesNo longer taking part
- Hospital for Special SurgeryNew York, United StatesNo longer taking part
- University of Nebraska Medical CenterOmaha, United StatesNo longer taking part
- Stanford Neuroscience Medical CenterPalo Alto, United StatesNo longer taking part
- University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- Neuromuscular Research CenterPhoenix, United StatesNo longer taking part
- UPMC Arthritis and Autoimmunity Center, Falk ClinicPittsburgh, United StatesNo longer taking part
- Oregon Health Science UniversityPortland, United StatesNo longer taking part
- Mayo ClinicRochester, United StatesNo longer taking part
- University of California San FranciscoSan Francisco, United StatesNo longer taking part
- University of Washington Medical Center - MontlakeSeattle, United StatesNo longer taking part
- Washington University School of MedicineSt Louis, United StatesNo longer taking part
- Wake Forrest School of MedicineWinston-Salem, United StatesNo longer taking part
About the trial
What the trial wants to find out
A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis
The 3 groups in the trial
- 0.5 mg/kg ABC008Existing treatment, for comparison
Part A - ABC008 N=12 Part B - ABC008 N= 67
Treatment: ABC008
- 2.0 mg/kg ABC008Existing treatment, for comparison
Part A - ABC008 N=12 Part B - ABC008 N= 67
Treatment: ABC008
- PlaceboPlacebo, for comparison
Part A - Placebo N= 6 Part B - Placebo N= 67
Treatment: ABC008
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABC008 in the Treatment of Subjects With Inclusion Body Myositis
- Record updated
- 1 October 2026