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TERMINATEDPHASE3

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study

NCT04044690•CSL Behring

View on ClinicalTrials.gov

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 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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

Locations (76)

8401117 - Arizona Arthritis & Rheumatology Research

Glendale, Arizona, United States

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

Key Dates

Start Date

October 21, 2019

Primary Completion Date

December 2, 2024

Completion Date

December 2, 2024

Last Updated

December 9, 2025

Enrollment

134

ACTUAL participants

Conditions

Dermatomyositis

Interventions

human immunoglobulin G

DRUG

Placebo

DRUG

Rheumatology Patient Registry and Biorepository

NCT04402086

Rheumatic DiseasesAdult Onset Still Disease+18 more

View study

RECRUITINGPHASE2/PHASE3

Safety and Efficacy of ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM), Also Known as Idiopathic Inflammatory Myopathy (IIM)

NCT07160205

Idiopathic Inflammatory Myositis (IIM)DERMATOMYOSITIS OR POLYMYOSITIS

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)

Inclusion Criteria

Exclusion Criteria

Rheumatology Patient Registry and Biorepository

Safety and Efficacy of ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM), Also Known as Idiopathic Inflammatory Myopathy (IIM)

MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS)

Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders

Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)

Clinical Responsiveness of Dermatomyositis Using Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)