Status:
RECRUITING
The MIGHT Trial - An Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Octapharma USA, Inc.
Conditions:
Anti-3-hydroxy-3-methylglutaryl-CoA Reductase (HMGCR) Immune-Mediated Necrotizing Myopathy
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief 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 redu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06599697
Start Date
October 27 2025
End Date
June 30 2027
Last Update
October 29 2025
Active Locations (5)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Johns Hopkins University
Baltimore, Maryland, United States, 21218
3
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
4
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030