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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

IRB Number: 2023-0068

February 08, 2024

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.

For further information, see Understanding Clinical Trials/Research Studies.

Principal Investigator

David R. Fernandez, MD, PhD


Robert F. Spiera, MD

Kimberly Lakin, MD, MS

Jessica K. Gordon, MD

Lindsay S. Lally, MD




This is a his study soughts to find the safety and efficacy of subcutaneous injections of ABC008, a humanized a fucosylated monoclonal antibody directed against Killer Cell Lectin-Like Receptor Gl (KLRGl). This is a two part study with Part A being the sentinel cohort for safety analysis started in May of 2023 in which participants were blindly randomized and given subcutaneous injections of ABC008 or placebo every eight weeks with more frequent appointments in between. 

Inclusion/Exclusion Criteria

Inclusion Criteria:

  • Adult males and females age >40 years at the time of the first dose of study medication.
  • Weight >40 and <115 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 type myositis or myopathy other than IBM and which include, but are not limited to the following:
    • 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)
    • muscular dystrophy
  • Any condition that severely limits the subject’s range of motion (e.g., severe degenerative arthritis) allowing for an inability 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 included but not limited to the following:
    • 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.
  • Subjects that had/have recent serious infection that required the use of oral antibiotics/antifungals/antivirals therapy, any form of COVID-19 infection within two days of screening, and any past history of HBV, HCV, HIV, or active form of TB.
  • Any women of child bearing potential who are pregnant, lactating, or discontinued lactation within 12 weeks of study start date.

Contact Information

Ryan Heise