Telitacicept
Telitacicept (RC-18) is a novel, recombinant fusion protein, consisting of transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) and the Fc portion of human immunoglobulin G (IgG) (TACI-Fc). It was designed to inhibit the activity of two target cytokines, the B-cell lymphocyte stimulator (BLyS, also known as the B-cell activation factor [BAFF]) and a proliferation-inducing ligand (APRIL), both of which are involved in the pathogenesis of SLE.
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How is Telitacicept being studied in Lupus nephritis?
The safety and efficacy of Telitacicept in adult patients with active lupus nephritis while taking standard of care treatment is being tested in the phase 2, multicentre, randomized, double-blind, placebo-controlled study. The participants will be randomized to receive Telitacicept 240 mg, Telitacicept 160 mg sc or placebo through week 48. The primary endpoint is the percentage of participants with complete renal response and the secondary end point is the percentage of participants with partial renal response.
Eligibility Criteria
Age 18-75 years
Active, biopsy-proven proliferative lupus nephritis Class III or IV with/without the presence of Class V, or pure Class V according to the 2003 ISN/RPS classification.
Positive antinuclear antibody (ANA) and/or a positive anti-dsDNA serum antibody
Active renal disease at screening requiring induction therapy with high dose corticosteroids with mycophenolate mofetil and induction therapy should be initiated within 60 days prior to or on Day 1 (baseline).