Telitacicept for Lupus

Recruiting at 3 trial locations

Overseen By RemeGen

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: RemeGen Co., Ltd.

Must be taking: Corticosteroids, Antimalarials, Immunosuppressives

Disqualifiers: Lupus nephritis, Neuropsychiatric SLE, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

350 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that participants should be on at least one standard SLE medication like oral corticosteroids, antimalarials, or immunosuppressive agents.

What data supports the effectiveness of the drug Telitacicept for treating lupus?

Telitacicept has shown clinical benefits in treating systemic lupus erythematosus (SLE) in Chinese patients, and it has been conditionally approved in China for this use. It works by targeting specific proteins involved in the disease, and studies suggest it is well tolerated and effective in reducing symptoms. ^{1 2 3 4 5}

Is telitacicept safe for humans?

Telitacicept has been studied for safety in people with systemic lupus erythematosus (SLE), and it appears to be well tolerated in these patients. It has received approval in China for treating active SLE, indicating that it has passed safety evaluations for this condition. ^{1 2 3 4 6}

What makes the drug Telitacicept unique for treating lupus?

Telitacicept is unique because it targets and neutralizes two specific molecules, B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which are involved in the survival of B cells that contribute to lupus. This mechanism helps reduce the activity of the immune system in a way that is different from other treatments. ^{1 2 4 5 6}

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.

Eligibility Criteria

This trial is for people aged 12-70 with moderately to severely active Systemic Lupus Erythematosus (SLE). Participants must have been diagnosed at least 6 months prior and meet specific SLE criteria, including a minimum disease activity score. They should be on standard treatments like steroids or antimalarials.

Inclusion Criteria

I have been diagnosed with lupus according to the 2019 EULAR/ACR criteria.

My lupus is active, with a SELENA SLEDAI score of 6 or more.

My lupus is active, affecting my organs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telitacicept or placebo in addition to standard of care therapy

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Telitacicept

Trial Overview The study tests Telitacicept's effectiveness and safety against a placebo in treating SLE. Participants will randomly receive either the actual drug or a placebo without knowing which one they are getting, to compare outcomes fairly.

Participant Groups

Group I: Telitacicept Experimental Treatment 1 Intervention

Telitacicept + Standard of Care (SOC)

Group II: Placebo Placebo Group 1 Intervention

Placebo + Standard of Care (SOC)

Telitacicept is already approved in China for the following indications:

Approved in China as Tai'ai for:

• Systemic lupus erythematosus (SLE)

Who Is Running the Clinical Trial?

RemeGen Co., Ltd.

Lead Sponsor

Trials

84

Recruited

11,100+

Dr. Jianmin Fang

RemeGen Co., Ltd.

Chief Executive Officer since 2008

PhD in Molecular Biology

Dr. Ruyi He

RemeGen Co., Ltd.

Chief Medical Officer since 2023

MD

Findings from Research

In a study of Chinese patients with systemic lupus erythematosus (SLE) receiving telitacicept for 4 to 45 weeks, 80% achieved a significant improvement in disease activity as measured by the SLE responder index-4 (SRI-4).

Telitacicept treatment led to a significant reduction in prednisolone dosage and an increase in the number of patients not requiring immunosuppressive drugs, indicating its potential to effectively manage SLE while minimizing the use of traditional medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of telitacicept for the treatment of systemic lupus erythematosus: a real life observational study. Chen, R., Fu, R., Lin, Z., et al.[2023]

In a study of 72 patients with active systemic lupus erythematosus (SLE) treated with telitacicept for over 24 weeks, 80.95% achieved significant improvement in disease activity by 52 weeks, indicating its efficacy in managing SLE.

Telitacicept was found to be safe, with no severe adverse events reported, and it notably improved renal function in patients with lupus nephritis, as evidenced by a significant reduction in urinary protein levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of telitacicept in patients with systemic lupus erythematosus: a multicentre, retrospective, real-world study. Jin, HZ., Li, YJ., Wang, X., et al.[2023]

Telitacicept, a novel treatment for systemic lupus erythematosus (SLE), has shown clinical benefits in Chinese patients with moderate to severe SLE when used alongside standard therapy, and it was well tolerated at doses of 80, 160, and 240 mg.

The drug targets key cytokines involved in B cell activity, receiving conditional marketing approval in China and fast track designation from the FDA in the U.S., highlighting its potential as an effective treatment for this autoimmune disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telitacicept, a novel humanized, recombinant TACI-Fc fusion protein, for the treatment of systemic lupus erythematosus. Fan, Y., Gao, D., Zhang, Z.[2022]

In a study of 15 children with refractory childhood-onset systemic lupus erythematosus (cSLE), telitacicept significantly improved disease response, with 66.7% of participants achieving the SLE responder index-4 (SRI-4) after 5-26 weeks of treatment.

Telitacicept also allowed for a substantial reduction in glucocorticoid dosage and showed efficacy in improving kidney function in some patients, with manageable adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of telitacicept in refractory childhood-onset systemic lupus erythematosus: A self-controlled before-after trial. Sun, L., Shen, Q., Gong, Y., et al.[2022]

Telitacicept is a new treatment that has been approved in China for adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE), showing promise in managing refractory cutaneous symptoms of the disease.

The drug works by neutralizing B-cell lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), and it has received fast track designation from the FDA for SLE, indicating its potential as an important therapeutic option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telitacicept for Recalcitrant Cutaneous Manifestations of Systemic Lupus Erythematosus: A Case Report and Review of the Literature. Ma, X., Fu, X., Cui, B., et al.[2022]

Telitacicept is a novel fusion protein that targets and neutralizes B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which are crucial for the survival of B cells, making it a promising treatment for B cell-mediated autoimmune diseases.

In March 2021, telitacicept received its first approval in China for treating active systemic lupus erythematosus (SLE), and it is currently being studied for several other autoimmune conditions, indicating its potential broad therapeutic application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telitacicept: First Approval. Dhillon, S.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

The efficacy and safety of telitacicept for the treatment of systemic lupus erythematosus: a real life observational study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of telitacicept in patients with systemic lupus erythematosus: a multicentre, retrospective, real-world study. [2023]

3. Spain pubmed.ncbi.nlm.nih.gov

Telitacicept, a novel humanized, recombinant TACI-Fc fusion protein, for the treatment of systemic lupus erythematosus. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of telitacicept in refractory childhood-onset systemic lupus erythematosus: A self-controlled before-after trial. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

Telitacicept for Recalcitrant Cutaneous Manifestations of Systemic Lupus Erythematosus: A Case Report and Review of the Literature. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Telitacicept: First Approval. [2022]