This study is in progress, not accepting new patients

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

a study on Dermatomyositis Diabetes

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Dermatomyositis, Immunoglobulins, Intravenous Immunoglobulins, Antibodies, Immunoglobulin G, human immunoglobulin G, IgPro20

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • 8401129 - UCLA - Rheumatology Los Angeles
    Los Angeles California 90095 United States
  • 8401117 - Arizona Arthritis & Rheumatology Research
    Glendale Arizona 85306 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CSL Behring
ID
NCT04044690
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 126 study participants
Last Updated