A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
Megadott ok: Primary endpoint not attained
A legfontosabb adatok
- Hol
- Boynton Beach, Columbus, Fairway, Fort Lauderdale, Glendale, Houston, Jackson, Los Angeles, Louisville, Orlando, Philadelphia, Phoenix, Pittsburgh, Portland és Tampa (Egyesült Államok)Mind a 15 helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Egyesült Államok
- 8401473 - RecioMed Clinical Research Network, Inc.Boynton Beach, Egyesült ÁllamokNo longer taking part
- 8401487 - Ohio State UniversityColumbus, Egyesült ÁllamokNo longer taking part
- 8401152 - The University of Kansas Medical CenterFairway, Egyesült ÁllamokNo longer taking part
- 8401160 - Center For RheumatologyFort Lauderdale, Egyesült ÁllamokNo longer taking part
- 8401117 - Arizona Arthritis & Rheumatology ResearchGlendale, Egyesült ÁllamokNo longer taking part
- 8401115 - The University of Texas Medical School at HoustonHouston, Egyesült ÁllamokNo longer taking part
- 8401474 - West Tennessee Research Institute, LLCJackson, Egyesült ÁllamokNo longer taking part
- 8401129 - UCLA - Rheumatology Los AngelesLos Angeles, Egyesült ÁllamokNo longer taking part
- 8401476 - DS ResearchLouisville, Egyesült ÁllamokNo longer taking part
- 8401132 - Omega Research MaitlandOrlando, Egyesült ÁllamokNo longer taking part
- 8401210 - University of PennsylvaniaPhiladelphia, Egyesült ÁllamokNo longer taking part
- 8401199 - Neuromuscular Research CenterPhoenix, Egyesült ÁllamokNo longer taking part
- 8401151 - Biomedical Science TowerPittsburgh, Egyesült ÁllamokNo longer taking part
- 8401486 - Oregon Health and Science UniversityPortland, Egyesült ÁllamokNo longer taking part
- 8401107 - Morsani Center for Advanced Health Care (CAHC)Tampa, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- CSL Behring
- Azonosító
- NCT04044690EU 2023-508293-28-00
- A regiszteradat frissítve
- 2025. december 9.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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.