Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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;
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 1/30/2024. Questions regarding updates should be directed to the study team contact.