A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)
- Conditions
- DermatomyositisDermatomyositis is a rare inflammatory disease marked by muscle weakness and a distinctive skin rash.
- Registration Number
- JPRN-jRCT2080224869
- Lead Sponsor
- CSL Behring K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- 126
Male or female subjects >= 18 years of age with diagnosis of at least probable idiopathic inflammatory myopathies per European League Against
Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria which includes confirmation of DM rash/manifestation, disease activity defined by presence of DM rash/manifestation or an objective disease activity measure, and disease severity defined by Physician Global Visual Analog Scale (VAS) with a minimum value of 2.0 cm on a 10 cm scale and Manual Muscle Test (MMT)-8 <= 142 or Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score >= 14.
Cancer-associated myositis, evidence of active malignant disease or malignancies diagnosed within the previous 5 years, Physician Global Damage >= 3, or clinically relevant improvement between Screening Visit and Baseline
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method