drugset / Trial / NCT04450654
Monotherapy IVIG Gamunex-C for HMG-CoA Reductase Auto-Antibody Positive Necrotizing Myopathy Treatment (The MIGHT Trial)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 2 g/kg | Intravenous |