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Dermatomyositis

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
NCT04044690 | Phase 3 | Interventional

This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of IgPro20 (subcutaneous Ig) treatment in adult subjects with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of IgPro20 subcutaneous (SC) doses in comparison to placebo in adult subjects with DM, as measured by responder status based on Total Improvement Score (TIS) assessments.

Trial Information
13 Sites
126 Participants
Recruiting
18 Years

If interested, contact clinicaltrials@cslbehring.com for more information

Arizona Arthritis & Rheumatology Research
Glendale, Arizona, 85306, United States
Neuromuscular Research Center
Phoenix, Arizona, 85028, United States
UCLA Rheumatology Los Angeles
Los Angeles, California, 90095, United States
Center For Rheumatology
Fort Lauderdale, Florida, 33334, United States
Omega Research Maitland
Orlando, Florida, 32810, United States
Morsani Center for Advanced Health Care (CAHC)
Tampa, Florida, 33616, United States
The University of Kansas Medical Center
Fairway, Kansas, 66205, United States
Northwell Health Physicians
Great Neck, New York, 11021, United States
Paramount Medical Research & Consulting
Middleburg Heights, Ohio, 44130, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Biomedical Science Tower
Pittsburgh, Pennsylvania, 15261, United States
West Tennessee Research Institute, LLC
Jackson, Tennessee, 38305, United States
The University of Texas Medical School at Houston
Houston, Texas, 77030, United States

Study Eligibility Criteria

  • Male or female subjects ≥ 18 years of age
  • Diagnosis of at least probable idiopathic inflammatory myopathies (IIM) per European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria which includes confirmation of dermatomyositis (DM) rash/manifestation, disease activity defined by presence of DM rash / manifestation or an objective disease activity measure
  • Disease severity defined by Physician global activity visual analog scale (VAS) with a minimum value of 2.0 cm on a 10 cm scale and MMT-8 ≤ 142 or CDASI total activity score ≥ 14.
  • Corticosteroid daily dose less than that or equal to 20 mg prednisolone equivalent
  • Cancer-associated myositis
  • Evidence of active malignant disease or malignancies diagnosed within the previous 5 years
  • Physician Global Damage score ≥ 3, or clinically relevant improvement between Screening Visit and Baseline

Additional Studies

Additional studies can be found at ClinicalTrials.gov