Trial of IMO-8400 in Adult Patients With Dermatomyositis

Completed · Phase 2 · Has a placebo group

Conditions studied: Dermatomyositis

In brief

The purpose of this study is to determine how safe and effective IMO-8400 is in adults with dermatomyositis.

Key facts

Study ID

NCT02612857

Run by

Idera Pharmaceuticals, Inc.

People needed

30

Starts

2015-11-01

Expected to finish

2018-06-01

Last updated by the study team

2019-10-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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):
• 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)
• Intravenous corticosteroids within 12 weeks
• Antimalarials (e.g., hydroxychloroquine) within 36 weeks
• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Phoenix Neurological Associates — Phoenix, Arizona, United States
• University of California, Irvine — Irvine, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• George Washington University — Washington D.C., District of Columbia, United States
• University of Miami — Miami, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• University of Kansas — Kansas City, Kansas, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Northwell Health — Great Neck, New York, United States
• Ohio State University — Columbus, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Vermont College of Medicine — Burlington, Vermont, United States
• University of Debrecen — Debrecen, Hungary
• MRC/ARUK Institute of Ageing and Chronic Disease, University of Liverpool — Liverpool, United Kingdom
• University College London Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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