A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
Reason given: Primary endpoint not attained
Key facts
- Where
- Boynton Beach, Columbus, Fairway, Fort Lauderdale, Glendale, Houston, Jackson, Los Angeles, Louisville, Orlando, Philadelphia, Phoenix, Pittsburgh, Portland, and Tampa, United StatesSee the 15 sites
- Phase
- Phase 3
Where in United States
- 8401473 - RecioMed Clinical Research Network, Inc.Boynton Beach, United StatesNo longer taking part
- 8401487 - Ohio State UniversityColumbus, United StatesNo longer taking part
- 8401152 - The University of Kansas Medical CenterFairway, United StatesNo longer taking part
- 8401160 - Center For RheumatologyFort Lauderdale, United StatesNo longer taking part
- 8401117 - Arizona Arthritis & Rheumatology ResearchGlendale, United StatesNo longer taking part
- 8401115 - The University of Texas Medical School at HoustonHouston, United StatesNo longer taking part
- 8401474 - West Tennessee Research Institute, LLCJackson, United StatesNo longer taking part
- 8401129 - UCLA - Rheumatology Los AngelesLos Angeles, United StatesNo longer taking part
- 8401476 - DS ResearchLouisville, United StatesNo longer taking part
- 8401132 - Omega Research MaitlandOrlando, United StatesNo longer taking part
- 8401210 - University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- 8401199 - Neuromuscular Research CenterPhoenix, United StatesNo longer taking part
- 8401151 - Biomedical Science TowerPittsburgh, United StatesNo longer taking part
- 8401486 - Oregon Health and Science UniversityPortland, United StatesNo longer taking part
- 8401107 - Morsani Center for Advanced Health Care (CAHC)Tampa, United StatesNo longer taking part
Trial details
- Who runs it
- CSL Behring
- Trial code
- NCT04044690EU 2023-508293-28-00
- Record updated
- 9 December 2025
- Original description
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.Read full original descriptionShow less
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study
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.
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: Evidence of active malignant disease or malignancies diagnosed within the previous 5 years; Cancer-associated myositis; Physician Global Damage score ≥ 3, or clinically relevant improvement between Screening Visit and Baseline.