A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Dermatomyositis
In brief
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.
Key facts
- Study ID
- NCT04044690
- Run by
- CSL Behring
- People needed
- 134
- Starts
- 2019-10-21
- Expected to finish
- 2024-12-02
- Last updated by the study team
- 2025-12-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 8401199 - Neuromuscular Research Center — Phoenix, Arizona, United States
- 8401129 - UCLA - Rheumatology Los Angeles — Los Angeles, California, United States
- 8401473 - RecioMed Clinical Research Network, Inc. — Boynton Beach, Florida, United States
- 8401160 - Center For Rheumatology — Fort Lauderdale, Florida, United States
- 8401132 - Omega Research Maitland — Orlando, Florida, United States
- 8401107 - Morsani Center for Advanced Health Care (CAHC) — Tampa, Florida, United States
- 8401152 - The University of Kansas Medical Center — Fairway, Kansas, United States
- 8401476 - DS Research — Louisville, Kentucky, United States
- 8401487 - Ohio State University — Columbus, Ohio, United States
- 8401486 - Oregon Health and Science University — Portland, Oregon, United States
- 8401210 - University of Pennsylvania — Philadelphia, Pennsylvania, United States
- 8401151 - Biomedical Science Tower — Pittsburgh, Pennsylvania, United States
- 8401474 - West Tennessee Research Institute, LLC — Jackson, Tennessee, United States
- 8401115 - The University of Texas Medical School at Houston — Houston, Texas, United States
- 0320083 - Hospital Italiano de Buenos Aires — Ciudad Autónoma Buenos Aires, Buenos Aires, Argentina
- 0320084 - DIM Clinica Privada — Buenos Aires, Argentina
- 0320081 - Fundacion Respirar — Buenos Aires, Argentina
- 0320077 - Centro Medico Privado de Reumatolgia — San Miguel de Tucumán, Argentina
- 0560050 - Ghent Universit Hospital (UZ Gent) — Ghent, Belgium
- 0560048 - Universitair Ziekenhuis (UZ) Leuven — Leuven, Belgium
- 0560056 - Universitair Ziekenhuis Leuven — Leuven, Belgium
- 0560049 - CHU de Liège - Sart Tilman — Liège, Belgium
- 2500146 - CHU De Dijon Hopital Du Bocage — Dijon, France
- 2500188 - Centre Hospitalier Regional Universitaire de Lille — Lille, France
- 8401117 - Arizona Arthritis & Rheumatology Research — Glendale, Arizona, United States
Full record on ClinicalTrials.gov
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