Trial of IMO-8400 in Adult Patients With Dermatomyositis

Exclusion Criteria

• •Has ongoing severe dysphagia (e.g., requires a feeding tube) for the 3 months prior to Screening
• •Has known hypersensitivity to any oligodeoxynucleotide
• •Has a history of drug or alcohol abuse within one year of screening, or evidence of drug abuse by urine drug screening
• •Has body weight \>140 kg
• •Has a diagnosis of Juvenile DM, IBM, drug-induced toxic myopathy, metabolic myopathy, dystrophy, cancer-associated DM, or connective tissue disease-associated DM (e.g., overlap syndrome)
• •Has received one or more of following prohibited treatments within the interval noted prior to Screening (Visit 1):
• •1. Rituximab within 24 weeks (Note: patients who received rituximab are only eligible for inclusion if B-cell counts are confirmed to be within normal limits)
• •2. Intravenous corticosteroids within 12 weeks
• •3. Antimalarials (e.g., hydroxychloroquine) within 36 weeks
• •4. Topical corticosteroids (excluding scalp) within 2 weeks
• •Has evidence of or has required treatment for cancer (except for treated, non-invasive carcinoma of the skin or cured cervical carcinoma-in-situ) within 5 years
• •Has interstitial lung disease requiring the use of supplemental oxygen