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RECRUITING
NCT06599697
PHASE2

The MIGHT Trial - An Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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