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The MIGHT Trial - An Exploratory Clinical Trial of IVIG in anti-HMGCR ImmuneMediated Necrotizing Myopathy

US · IL NIH grant open #nih-5R21AR083566-02

Summary

Conduct a pilot, exploratory, phase 2, double-blinded, placebo-controlled clinical trial to assess the safety, tolerability, and initial efficacy of IVIG for anti-HMGCR immune-mediated necrotizing myopathy (IMNM) and to study its immunologic effects.

What they want

The project involves two main aims: 1) a randomized, placebo-controlled trial (RCT) to demonstrate the safety, tolerability, and initial efficacy of IVIG for anti-HMGCR IMNM, providing critical pilot data towards a future phase 3 trial; and 2) an immunology study to determine whether immunologic features of HMGCR-specific CD4+ T cells (prevalence, effector function, and epitope specificity) are biomarkers of disease activity and are affected by IVIG in anti-HMGCR IMNM. This proposal is responsive to PAR-21-045, which calls for exploratory clinical trials in autoimmune and musculoskeletal conditions.
Deliverables
  • Pilot data on the safety, tolerability, and initial efficacy of IVIG for anti-HMGCR IMNM
  • Data on the relationships of HMGCR-specific CD4+ T cells with disease activity
  • Data on the effect of immunomodulatory therapy (IVIG) on HMGCR-specific CD4+ T cells
Technical requirements
  • Phase 2 clinical trial
  • Double-blinded trial design
  • Placebo-controlled trial design

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

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