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

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

Outcome

Missed primary endpoint

Stopped: “Primary endpoint not attained”

registry analysis (superiority test); IgPro20 vs Placebo; p = 0.371008; Odds Ratio (OR) 1.13 (95% CI 0.551 to 2.309) NCT04044690 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Immune Globulin Intravenous (Human)	Protein / enzyme biologic	—	Subcutaneous

Indications