drugset / Trial / NCT04044690

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

NCT04044690

Phase 3 Terminated 134 enrolled CSL Behring
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2019-10-21
Primary completion
2024-12-02
Completion
2024-12-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic Subcutaneous

Indications