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New treatment option for Anti-3-hydroxy-3-methylglutaryl-CoA Reductase (HMGCR) Immune-Mediated...
Official title The MIGHT Trial - An Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy
ClinicalTrials.gov ID: NCT06599697
What this study is testing
What is Intravenously administered pooled human immunoglobulin (IVIG)?
Intravenously administered pooled human immunoglobulin (IVIG) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anti-3-hydroxy-3-methylglutaryl-coa reductase (hmgcr) immune-mediated necrotizing myopathy.
Also referred to as Octagram -Immune Globulin Intravenous (Human).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Baltimore, Maryland, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Baltimore, Maryland, United States; Pittsburgh, Pennsylvania, United States; Houston, Texas, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.