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IONIS-FB-LRx

IONIS-FB-LRx is a ligand-conjugated (LICA) investigational antisense medicine designed to reduce the production of complement factor B (FB). Genetic association studies have shown that overaction of this cascade has been associated with the development of several complement-mediated diseases, including IgA nephropathy (IgAN). FB, a key regulatory protein, is produced predominantly in the liver and circulates at high levels throughout the vascular system, including in the kidney.

Wavy Abstract Background

Enroll in this clinical study

Ionis Pharmaceuticals

(844) 727-6672

ionisNCT04014335study@clinicaltrialmedia.com

How is it being studied in IgA nephropathy?

In a proof-of-concept Phase 2, open label, single arm study of IONIS-FB-LRx,  25 participants  will receive IONIS-FB-LRx, by subcutaneous injection (SC) at Week 1 and every 4 weeks through Week 25.  The primary endpoint in the study is the change in 24-hour urine protein excretion from baseline to week 29. The study is also evaluating reduction in plasma complement Factor B, measures of kidney function and safety and tolerability of monthly dosing of IONIS-FB-LRx. 

Eligibility Criteria

  1. Age 18-75 years

  2. Hematuria

  3. Proteinuria

  4. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal OR use a highly effective method of birth control

  5. Biopsy-proven primary immunoglobulin A (IgA) nephropathy with eGFR > 40ml/min

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