Condition: Anti-3-hydroxy-3-methylglutaryl-CoA Reductase (HMGCR) Immune-Mediated Necrotizing Myopathy · Sponsor: University of Alabama at Birmingham
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.
This description comes directly from the study's public registry record.
James Andrews, MD · (205) 934-1564 · jaandrews@uabmc.edu
Hannah E Howell, MS · 205-996-6552 · heburns@uabmc.edu
Always discuss trial participation with your own doctor first.
| University of Alabama at Birmingham | Birmingham, Alabama, United States | Recruiting |
| Johns Hopkins University | Baltimore, Maryland, United States | Not Yet Recruiting |
| University of Pittsburgh | Pittsburgh, Pennsylvania, United States | Not Yet Recruiting |
| University of Texas Health Science Center at Houston | Houston, Texas, United States | Active Not Recruiting |
| University of Washington | Seattle, Washington, United States | Active Not Recruiting |
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Source record: clinicaltrials.gov/study/NCT06599697