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

NCT04044690 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2025-12-09

Study results available
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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.

Conditions

  • Dermatomyositis

Interventions

DRUG

human immunoglobulin G

human immunoglobulin G administered subcutaneously

DRUG

Placebo

contains 2% human albumin, similar excipients as IgPro20 (Hizentra), same volume, same duration, administered subcutaneously

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Study Director · CSL Behring

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-21
Primary Completion
2024-12-02
Completion
2024-12-02
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Mexico
  • Poland
  • Russia
  • Spain
  • Switzerland
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04044690 on ClinicalTrials.gov