Trial of IMO-8400 in Adult Patients With Dermatomyositis



Status:Completed
Conditions:Skin and Soft Tissue Infections
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:1/30/2019
Start Date:November 2015
End Date:June 2018

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients With Dermatomyositis

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

This study will evaluate the safety and efficacy of IMO-8400 in adults with active
dermatomyositis (DM).

Inclusion Criteria:

- 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

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
We found this trial at
18
sites
1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
Principal Investigator: Wagar Waheed, MD
Phone: 802-656-4582
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Lisa Christopher-Stine, MD
Phone: 410-550-1741
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Anthony Amato, MD
Phone: 617-525-6763
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Dana P. Ascherman, MD
Phone: 305-243-8567
University of Miami A private research university with more than 15,000 students from around the...
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5090 N 40th St # 250
Phoenix, Arizona 85018
Principal Investigator: Todd Levine, MD
Phone: 602-288-4673
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Chester Oddis, MD
Phone: 412-383-8674
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-998-1271
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Birmingham, Alabama 35294
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Katherine Ruzhansky, MD
Phone: 843-792-3790
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Anne Laumann, MD
Phone: 312-503-5906
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 614-688-7837
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Debrecen, 4032
Principal Investigator: Katalin Danko, MD
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Great Neck, New York 11021
Principal Investigator: Galina Marder, MD
Phone: 516-708-2557
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Irvine, California 92697
949-824-5011
Principal Investigator: Tahseen Mozzafar, MD
Phone: 714-456-8520
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Kansas City, Kansas
Principal Investigator: Mazen Dimachkie, MD
Phone: 913-945-9945
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Saint Louis, Missouri 63110
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Stanford, California 94305
Principal Investigator: Mazen Dimachkie, MD
Phone: 650-725-4612
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Washington, District of Columbia 20052
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