- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis (clinicaltrials.gov) - Feb 12, 2025 P2, N=38, Recruiting, However, larger-scale and longer-term studies are necessary to confirm these results and fully establish the role of telitacicept in the treatment of gMG. Not yet recruiting --> Recruiting | Trial completion date: Dec 2026 --> Dec 2027 | Initiation date: Jun 2024 --> Jan 2025 | Trial primary completion date: Aug 2025 --> Jan 2027
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Journal: Telitacicept for refractory cystitis associated with severe systemic lupus erythematosus: A case report. (Pubmed Central) - Jan 29, 2025 Telitacicept exhibited a highly effective and favorable safety in patients with SLE, with improved renal and hematological manifestations and facilitated a reduction in glucocorticoid medication usage. This case highlights the therapeutic potential of telitacicept for SLE patients who are unresponsive to conventional therapies, particularly those with severe manifestations such as lupus cystitis.
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Clinical, Retrospective data, Journal: Efficacy and safety of telitacicept in IgA nephropathy: A retrospective, multicenter study. (Pubmed Central) - Jan 13, 2025 Conclusions This study indicates that Telitacicept alone or on top of steroids therapy can significantly and safely reduce proteinuria in patients with IgAN. The long-term kidney protection still need to be confirmed in large Phase III trial.
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Retrospective data, Journal, Real-world evidence: Efficacy and safety of telitacicept in IgA nephropathy: a real-world study. (Pubmed Central) - Jan 12, 2025 No serious adverse events were observed in the telitacicept treatment group. Telitacicept may be an effective treatment for IgAN patients by reducing proteinuria and preserving eGFR, and showed a favorable safety profile.
- |||||||||| Benlysta (belimumab) / GSK, Tai'ai (telitacicept) / Rongchang Pharma, Rituxan (rituximab) / Roche
Journal: The efficacy of rituximab plus belimumab or telitacicept in refractory lupus nephritis. (Pubmed Central) - Jan 6, 2025 Telitacicept may be an effective treatment for IgAN patients by reducing proteinuria and preserving eGFR, and showed a favorable safety profile. Rituximab followed by belimumab or telitacicept may be effective in inducing remission in refractory lupus nephritis, with tolerable adverse effects.
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Enrollment open: Efficacy and Safety of Telitacicept in IgAN (clinicaltrials.gov) - Jan 3, 2025 P=N/A, N=118, Recruiting, Rituximab followed by belimumab or telitacicept may be effective in inducing remission in refractory lupus nephritis, with tolerable adverse effects. Not yet recruiting --> Recruiting
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma, Rituxan (rituximab) / Roche
Journal: Ovarian function in patients of childbearing age with systemic lupus erythematosus (Pubmed Central) - Dec 18, 2024 Ovarian function is decreased in SLE patients of childbearing age, and age and disease duration are the risk factors. The utilization of biological agents demonstrates favorable safety profiles regarding ovarian function in childbearing-age patients with SLE.
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Review, Journal: The Latest Progress in the Application of Telitacicept in Autoimmune Diseases. (Pubmed Central) - Dec 12, 2024 So far, the efficacy and safety of telitacicept in autoimmune diseases have been fully demonstrated in clinical practice. There are still many unresolved issues regarding the timing of initiation and discontinuation, still needs to be evaluated in future studies.
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma, Uplizna (inebilizumab-cdon) / Mitsubishi Tanabe, Amgen
Review, Journal: Neuromyelitis optica spectrum disorder with ultra-longitudinally extensive transverse myelitis: A case report and literature review. (Pubmed Central) - Nov 19, 2024 Simultaneously, sequential disease-modifying therapy was initiated, starting with long-term oral administration of mycophenolate mofetil, followed by cyclophosphamide, telitacicept, and Inebilizumab...Early and comprehensive evaluation of autoimmune diseases is crucial in patients with NMOSD presenting with u-LETM as the initial symptom. Prompt treatment initiation, followed by disease-modifying therapy, is essential for improving patient prognosis.
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Enrollment closed, Trial completion date, Trial primary completion date: A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1) (clinicaltrials.gov) - Nov 18, 2024 P3, N=350, Active, not recruiting, Prompt treatment initiation, followed by disease-modifying therapy, is essential for improving patient prognosis. Recruiting --> Active, not recruiting | Trial completion date: Sep 2025 --> Mar 2027 | Trial primary completion date: Jun 2025 --> Jan 2027
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Trial completion date, Trial primary completion date, Real-world evidence, Compliance, Real-world: Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - Oct 1, 2024 P=N/A, N=139, Recruiting, After a 24-week follow-up, the incidence of adverse events was lower for telitacicept than for conventional IS therapy. Trial completion date: Aug 2024 --> Dec 2024 | Trial primary completion date: Jul 2024 --> Oct 2024
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Trial completion date, Trial primary completion date: A Study of Telitacicept in Lupus Nephritis (clinicaltrials.gov) - Sep 22, 2024 P2, N=120, Recruiting, Participant recruitment and exclusion flowchart. Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Trial completion date, Trial primary completion date: A Study of Telitacicept in Subjects With Childhood-onset Systemic Lupus Erythematosus (clinicaltrials.gov) - Sep 22, 2024 P1, N=12, Recruiting, Trial completion date: Jan 2025 --> Jan 2026 | Trial primary completion date: Dec 2024 --> Dec 2025 Trial completion date: Dec 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Sep 2025
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Review, Journal: Telitacicept: A novel horizon in targeting autoimmunity and rheumatic diseases. (Pubmed Central) - Sep 9, 2024 This review consolidates information on the mechanistic actions, dosing regimens, pharmacokinetics, efficacy, and safety profile of telitacicept-a dual-targeted biological agent. It integrates findings from prior experiments and pharmacokinetic analyses in the treatment of RA and SLE, striving to offer a comprehensive overview of telitacicept's research advancements.
- |||||||||| Tai'ai (telitacicept) / Rongchang Pharma
Enrollment open, Trial completion date, Trial primary completion date: A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (RemeMG) (clinicaltrials.gov) - Aug 19, 2024 P3, N=180, Recruiting, No abstract available Not yet recruiting --> Recruiting | Trial completion date: Jul 2027 --> Oct 2027 | Trial primary completion date: Apr 2026 --> Jul 2026
|