MIGHT — IVIG for anti‑HMGCR immune‑mediated necrotizing myopathy
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)
Run by University of Alabama at Birmingham · NCT06599697 · Data updated 2026-11-12
This will test whether intravenous immunoglobulin (IVIG) helps people aged 16 and older with active anti‑HMGCR immune‑mediated necrotizing myopathy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Drugs / interventions | Rituximab, methotrexate, cyclophosphamide |
| Locations | 5 sites (Birmingham, Alabama and 4 other locations) |
| Status | Recruiting |
| Started | October 27, 2025 |
| Main results expected | December 30, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | August 5, 2026 |
| Trial ID | NCT06599697 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People aged 16 and older with active anti‑HMGCR IMNM (anti‑HMGCR antibody positive, CK >5× ULN, MMT‑8 <142), disease duration under 36 months, not on high‑dose glucocorticoids or prior IVIG, and who reside in a participating state are ideal candidates.
✕Probably not a fit
Patients with long-standing disease (>36 months), prior IVIG for IMNM, current statin use, significant respiratory or swallowing dysfunction, or on high-dose glucocorticoids are unlikely to be eligible and may not benefit from this specific protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double‑blind, placebo‑controlled phase 2 trial will compare IVIG 2 g/kg versus saline placebo given at weeks 0, 4, and 8 in 12 participants with active anti‑HMGCR IMNM. Primary efficacy and co‑primary safety/tolerability endpoints are assessed at week 12, and all participants may join an open‑label extension receiving IVIG at weeks 12, 16, and 20 with a final visit at week 24. Key inclusion criteria include anti‑HMGCR antibody positivity, serum CK >5× upper limit of normal, MMT‑8 <142, disease duration under 36 months, and residence in a participating state; major exclusions include prior IVIG for IMNM, current statin use, recent biologic/plasma exchange, or high‑dose glucocorticoids. The small planned sample size (12, anticipating ~10 completers) makes this an exploratory effort to generate preliminary safety and efficacy signals.
Why it matters
Potential benefit: If successful, IVIG could improve muscle strength and reduce muscle enzyme levels, offering a new treatment option for people with anti‑HMGCR IMNM.
How similar studies have gone: Case series and observational reports suggest IVIG can help immune‑mediated necrotizing myopathies including anti‑HMGCR cases, but randomized controlled evidence in this population is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 * Must reside in a state with a participating research site 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 ischemic attack, or stroke \< 12 months prior to screening * Females of child-bearing potential who are pregnant, breastfeeding, or are unwilling to practice a highly effective method of contraception during the study * Wells Criteria for DVT score of 2 or more at screening * Wells Criteria for PE score of 4 or more at screening * Weight \>120kg * History of cancer (excluding non-melanomatous skin cancer) \< 5 years prior to screening * History of pulmonary embolism or deep venous thromboembolism \< 3 years prior to screening * History of hyperviscosity or hypercoagulable state * Currently receiving anti-coagulation therapy (vitamin K antagonists, non-vitamin K oral anticoagulants \[e.g. dabigatran, rivaroxaban, apixaban\], parenteral anticoagulants \[e.g. fondaparinux\]. Note that oral anti-platelet agents are allowed (e.g. aspirin, clopidogrel, ticlopidine). * Glomerular filtration rate (GFR) \<60mL/min at the time of screening * Any medical condition which, in the investigator's judgment, makes participation in the clinical trial unadvisable or which would interfere with evaluation of the study treatment.
Where it's running
-
University of Alabama at Birmingham
Birmingham, Alabama, United States Recruiting -
University of Pittsburgh
Pittsburgh, Pennsylvania, United States Recruiting -
University of Texas Health Science Center at Houston
Houston, Texas, United States Recruiting -
Johns Hopkins University
Baltimore, Maryland, United States Not yet recruiting -
University of Washington
Seattle, Washington, United States Active not recruiting
Study contacts
- Principal investigator: James Andrews, MD — University of Alabama at Birmingham
- Study coordinator: James Andrews, MD
- Email: jaandrews@uabmc.edu
- Phone: (205) 934-1564
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.