Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Idera Pharmaceuticals, Inc.
This study will evaluate the safety and efficacy of IMO-8400 in adults with active dermatomyositis (DM).
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Has definite or probable DM based on the criteria of Bohan and Peter
Has a Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)-Activity score ≥15
Patients with muscle weakness are eligible; however having muscle weakness is not mandatory.
Study participants must have a diagnostic evaluation for cancer if the diagnosis of DM was within 2 years prior to the Screening Visit
You may not be if
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
