A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)
- Conditions
- DermatomyositisMedDRA version: 20.0 Level: LLT Classification code 10001403 Term: Adult dermatomyositis System Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-003171-35-ES
- Lead Sponsor
- CSL Behring LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 126
male or female subjects = 18 years of age with diagnosis of at least probable (idiopathic inflammatory myopathies) IIM per 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, 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 MMT-8 = 142 or CDASI total activity score = 14.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 94
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method