Actively Recruiting
The MIGHT Trial - An Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy
Led by University of Alabama at Birmingham · Updated on 2026-02-24
12
Participants Needed
5
Research Sites
87 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The MIGHT Trial - An Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 16 years
- Positive for anti-HMGCR antibodies
- Muscle strength (MMT-8) score less than 142
- Serum creatine kinase (CK) level more than 5 times the upper limit of normal
- Disease duration of anti-HMGCR IMNM less than 36 months at screening
- No moderate or severe breathing or swallowing problems from anti-HMGCR IMNM at screening
- No history of dermatomyositis rash
- Must live in a state with a participating research site
You will not qualify if you...
- Taking oral glucocorticoid dose greater than 15 mg daily at screening
- Changed oral glucocorticoid dose within 2 weeks before screening
- Previous IVIG treatment for anti-HMGCR IMNM
- Using more than one oral conventional synthetic DMARD at screening
- Changed dose of DMARDs within 4 weeks before screening
- Received rituximab within 6 months before screening
- Received plasma exchange, cyclophosphamide, or biologic immunosuppressive medication within 3 months before screening
- Using statin medication at screening
- History of severe allergic reaction to IVIG
- History of angina, heart attack, stroke, or transient ischemic attack within 12 months before screening
- Pregnant, breastfeeding, or unwilling to use effective birth control if female of childbearing potential
- Wells criteria score of 2 or more for deep vein thrombosis at screening
- Wells criteria score of 4 or more for pulmonary embolism at screening
- Weight over 120 kg
- History of cancer (except non-melanoma skin cancer) within 5 years before screening
- History of pulmonary embolism or deep vein thrombosis within 3 years before screening
- History of blood thickening or clotting disorders
- Currently using blood-thinning medications (except oral anti-platelet agents)
- Kidney function (GFR) less than 60 mL/min at screening
- Any medical condition that the investigator believes would make participation unsafe or interfere with study evaluation
AI-Screening
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Trial Site Locations
Total: 5 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Johns Hopkins University
Baltimore, Maryland, United States, 21218
Not Yet Recruiting
3
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Not Yet Recruiting
4
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Active, Not Recruiting
5
University of Washington
Seattle, Washington, United States, 98195
Active, Not Recruiting
Research Team
J
James Andrews, MD
CONTACT
H
Hannah E Howell, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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