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NCT06599697 · ClinicalTrials.gov registry record · Phase 2
The MIGHT Trial - An Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy
A Phase 2 study of Anti-3-hydroxy-3-methylglutaryl-CoA Reductase (HMGCR) Immune-Mediated Necrotizing Myopathy, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 5
- Study locations
NCT06599697 is a Phase 2 study of Anti-3-hydroxy-3-methylglutaryl-CoA Reductase (HMGCR) Immune-Mediated Necrotizing Myopathy that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 12 participants. The trial reports 5 study locations across 5 states.
The verdict
NCT06599697, a Phase 2 study of Anti-3-hydroxy-3-methylglutaryl-CoA Reductase (HMGCR) Immune-Mediated Necrotizing Myopathy, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 5
- Study locations
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Intravenously administered pooled human immunoglobulin (IVIG)
Study Locations (5)
Alabama
- University of Alabama at Birmingham - Birmingham
Maryland
- Johns Hopkins University - Baltimore
Pennsylvania
- University of Pittsburgh - Pittsburgh
Texas
- University of Texas Health Science Center at Houston - Houston
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-10-27 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06599697
The ClinicalTrials.gov registry entry for NCT06599697 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Anti-3-hydroxy-3-methylglutaryl-CoA Reductase (HMGCR) Immune-Mediated Necrotizing Myopathy appearing as the primary indexed condition, and to 1 intervention - of which Intravenously administered pooled human immunoglobulin (IVIG) is the first listed.
NCT06599697 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Alabama, Maryland, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06599697 about?
NCT06599697 is a clinical study titled "The MIGHT Trial - An Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy". 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...
What is the current status of trial NCT06599697?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2025-10-27. Estimated completion is 2027-06-30.
What conditions does trial NCT06599697 study?
This clinical trial studies the following conditions: Anti-3-hydroxy-3-methylglutaryl-CoA Reductase (HMGCR) Immune-Mediated Necrotizing Myopathy.
What interventions are being tested in trial NCT06599697?
The interventions under investigation include: Intravenously administered pooled human immunoglobulin (IVIG) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06599697?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06599697 being conducted?
This trial has 5 study locations across Alabama, Maryland, Pennsylvania, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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