Status:
TERMINATED
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
Lead Sponsor:
CSL Behring
Conditions:
Dermatomyositis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 stu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2024
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT04044690
Start Date
October 21 2019
End Date
December 2 2024
Last Update
December 9 2025
Active Locations (76)
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1
8401117 - Arizona Arthritis & Rheumatology Research
Glendale, Arizona, United States, 85306
2
8401199 - Neuromuscular Research Center
Phoenix, Arizona, United States, 85028
3
8401129 - UCLA - Rheumatology Los Angeles
Los Angeles, California, United States, 90095
4
8401473 - RecioMed Clinical Research Network, Inc.
Boynton Beach, Florida, United States, 33472