drugset / Trial / NCT04450654

Monotherapy IVIG Gamunex-C for HMG-CoA Reductase Auto-Antibody Positive Necrotizing Myopathy Treatment (The MIGHT Trial)

NCT04450654

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a phase 2, pilot, randomized, placebo-controlled trial of Gamunex-C IVIG as mono-therapy for HMGCoA reductase auto-antibody positive (HMGCR) necrotizing myopathy. The trial will test the feasibility and initial efficacy of Gamunex-C IVIG mono-therapy in HMGCR necrotizing myopathy.

Timeline

Start
2022-05
Primary completion
2022-07-25
Completion
2022-07-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 2 g/kg Intravenous