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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.
IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.
normal saline subcutaneous injections once a week for 24 weeks.
University of Alabama
Birmingham, Alabama, United States
Phoenix Neurological Associates
To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM
Number of participants with different types of Treatment Emergent Adverse Events
Time frame: 28 weeks (24 weeks treatment + 4 weeks follow up)
Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score
Change from baseline in mCDASI (Cutaneous Disease and Activity Severity Index) v2-Activity score as measured at Visits 2, 6, 10, 14, 18, 22 and 26 (EOT/ Week 25). Index is Clinician administered one page instrument designed to evaluate the cutaneous manifestations of DM. CDASI yields a total score that captures overall disease state, an activity score (range:0-100) that reflects the current inflammatory state of disease and a damage score (range: 0-32). The CDASI includes separate measurements for disease activity and damage and yields a total score that captures overall disease state, an activity score that reflects the current inflammatory state of disease, and a damage score. Decreases in CDASI scores are indicative of improvement. In this study, Activity Scores were measured. The scores below are averaged.
Time frame: 28 weeks (24 weeks treatment + 4 weeks follow up)
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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
...and 10 more locations