NCT06599697 · University of Alabama at Birmingham
The MIGHT Trial - An Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy
What this study is about
This is a randomly assigned, compared against an inactive treatment, double blinded phase 2 exploratory clinical trial of given through a vein (IV) administered pooled human immunoglobulin (IVIG) in anti-3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR) immune mediated necrotizing myopathy (IMNM).
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age \> 16 years
- Anti-HMGCR antibody positive
- MMT-8 score \< 142 (range 0-160)
- Serum CK \> 5x upper limit of normal
- Anti-HMGCR IMNM disease duration \< 36 months at screening
- No moderate or severe respiratory or swallowing dysfunction due to anti-HMGCR IMNM at screening
- No history of dermatomyositis rash
Exclusion criteria
- Oral glucocorticoid (GC) daily dose \> 15mg at screening
- Change in oral GC dose \< 2 weeks prior to screening
- Prior IVIG treatment for anti-HMGCR IMNM -\>1 oral conventional synthetic DMARD (e.g. methotrexate, mycophenolate mofetil, azathioprine) use at screening
- Change in concomitant DMARD dose \< 4 weeks prior to screening
- Rituximab \< 6 months prior to screening
- Plasma exchange, cyclophosphamide, or biologic immunosuppressive medication \< 3 months prior to screening
- Use of statin medication at screening
- History of anaphylactic reaction to IVIG
- History of angina pectoris, myocardial infarction, transient is
Where
- Birmingham, Alabama
- Baltimore, Maryland
- Pittsburgh, Pennsylvania
- Houston, Texas
- Seattle, Washington
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 24, 2026 · Source of record for eligibility and locations