Abstract: SA-OR083
Efficacy and Safety of Telitacicept in Patients with IgAN: Results from Stage A of a Phase 3 Clinical Study
Session Information
- High-Impact Clinical Trials - 2
November 08, 2025 | Location: Hall A, Convention Center
Abstract Time: 10:45 AM - 11:00 AM
Category: CKD (Non-Dialysis)
- 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Lv, Jicheng, Peking University First Hospital, Beijing, China
- Liu, Li-Jun, Peking University First Hospital, Beijing, China
- Wang, Wenxiang, RemeGen Co., Ltd, Yantai, Shandong, China
- Zhang, Jing, RemeGen Co., Ltd, Yantai, Shandong, China
- Mao, Weihong, RemeGen Co., Ltd, Yantai, Shandong, China
- Zuraw, Qing, Vor Biopharma Inc., Boston, Massachusetts, United States
- Perkovic, Vlado, University of New South Wales, Sydney, New South Wales, Australia
- Fang, Jianmin, RemeGen Co., Ltd, Yantai, China
- Zhang, Hong, Peking University First Hospital, Beijing, China
Background
The pathogenesis of immunoglobulin A nephropathy (IgAN) involves the production of pathogenic galactose-deficient IgA1 (Gd-IgA1), mediated by B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL). Telitacicept, a novel fusion protein that dually targets and neutralizes both BLyS and APRIL, showed efficacy and tolerability in a phase 2 study in patients with IgAN.
Methods
This phase 3, multicenter, randomized, double-blind, placebo-controlled, two-part (Stage A and B) study, enrolled adult patients with biopsy-proven IgAN at high risk of progression (24-hour urinary protein-to-creatinine ratio [UPCR] ≥0.8 g/g or total proteinuria ≥1.0 g/day) despite receiving stable, optimized renin–angiotensin system inhibitor therapy. In Stage A, patients were randomized (1:1) to receive subcutaneous telitacicept 240 mg or placebo weekly for 39 weeks. The primary efficacy endpoint was change from baseline in 24-hour UPCR at Week 39. Secondary endpoints included further assessments of proteinuria, changes in estimated glomerular filtration rate (eGFR), safety, and immunological parameters. Stage B, treatment from Week 40–104, is ongoing.
Results
A total of 318 patients were randomized (159 in each group). At Week 39 versus baseline, the geometric mean ratio (GMR) of UPCR was 0.41 and 0.91 in the telitacicept and placebo group, respectively (p<0.0001); the ratio of the GMR of UPCR was 55% lower (p<0.0001) with telitacicept versus placebo. The reduction in proteinuria was supported by consistent results in secondary endpoint analyses. The GMR ± standard error of eGFR was 0.99 ± 0.01 and 0.92 ± 0.01 in the telitacicept and placebo groups, respectively. The CD19+ B-cell count and IgG, IgA, and IgM levels decreased with telitacicept and were unchanged with placebo. The most common adverse events (AEs) with telitacicept were upper respiratory tract infections (16.4%) and injection site reactions (16.4%). The incidence of serious AEs was lower with telitacicept versus placebo (2.5% vs 8.2%).
Conclusion
In patients with IgAN at high risk of progression, treatment with telitacicept for 39 weeks resulted in a rapid, substantial, and statistically significant reduction in proteinuria compared with placebo, with a favorable safety profile.
Funding
- Commercial Support – RemeGen Co., Ltd.