A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Inclusion Body Myositis

In brief

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

Key facts

Study ID

NCT05721573

Run by

Abcuro, Inc.

People needed

272

Starts

2023-02-28

Expected to finish

2025-11-27

Last updated by the study team

2026-01-29

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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 it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.