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The MIGHT Trial - An Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy
Sponsor: University of Alabama at Birmingham
Summary
This is a randomized, placebo-controlled, double blinded phase 2 exploratory clinical trial of intravenously administered pooled human immunoglobulin (IVIG) in anti-3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR) immune mediated necrotizing myopathy (IMNM). Planned enrollment is 12 individuals with active anti-HMGCR IMNM meeting inclusion and exclusion criteria. Assuming 20% drop-out, the investigators anticipate 10 participants will complete all study assessments. Enrolled participants will be randomized 1:1 to either IVIG 2g/kg or placebo (0.9% sodium chloride at equivalent volume) at weeks 0, 4, and 8. The primary efficacy and co-primary safety and tolerability endpoints will be assessed at week 12. After the randomized phase of the trial, all participants will be offered to continue on to an open-label extension phase in which participants will receive IVIG at weeks 12, 16, and 20. Participants will then return at week 24 for a final non-infusion visit to reassess safety, tolerability, and efficacy outcome.
Official title: The MIGHT Trial - An Exploratory Clinical Trial of Intravenous Immunoglobulin (IVIG) in Anti-3-Hydroxy-3-Methylglutaryl-CoA Reductase (HMGCR) Immune Mediated Necrotizing Myopathy (IMNM)
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2025-10-27
Completion Date
2027-06-30
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Interventions
Intravenously administered pooled human immunoglobulin (IVIG)
IVIG 2g/kg every 4 weeks for 12 weeks (3 doses)
Locations (5)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Washington
Seattle, Washington, United States