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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests telitacicept, a new treatment for individuals with moderately to severely active lupus (SLE), to evaluate its effectiveness and safety. Participants will receive either telitacicept or a placebo, in addition to their regular lupus medications. Suitable candidates have had lupus for at least 6 months and are currently experiencing active symptoms despite treatment. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment for lupus.

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.

Is there any evidence suggesting that telitacicept is likely to be safe for humans?

Research has shown that telitacicept is generally safe for people with lupus. Some patients experience side effects, but these are usually mild to moderate, such as headaches and cold-like symptoms. Serious side effects are rare.

A recent study found that patients taking telitacicept had similar rates of side effects as those taking a placebo (a treatment with no active drug). This finding suggests that telitacicept is as safe as not taking the active drug. Overall, telitacicept appears to be a promising and safe option for treating lupus. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Telitacicept is unique because it targets two specific proteins, BLyS and APRIL, which play a crucial role in the survival of B cells, the immune cells involved in lupus. Most current treatments for lupus, like corticosteroids and immunosuppressants, broadly suppress the immune system, which can lead to significant side effects. Telitacicept's targeted approach may offer more precise control of the immune response, potentially reducing symptoms with fewer side effects. Researchers are excited about this treatment because it represents a more tailored approach to managing lupus, which could improve the quality of life for many patients.

What evidence suggests that telitacicept might be an effective treatment for lupus?

Research has shown that telitacicept, which participants in this trial may receive, may help treat systemic lupus erythematosus (SLE), a long-term autoimmune disease. In a previous study, 67.1% of patients with active SLE experienced a noticeable improvement in their symptoms after using telitacicept, meaning more than two-thirds of patients felt better. Earlier trials confirmed that telitacicept is effective and safe for people with SLE. These findings suggest that telitacicept could be a helpful treatment option for those dealing with lupus. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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 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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41092329/

A Phase 3 Trial of Telitacicept for Systemic Lupus ... In this 52-week trial involving participants with active SLE who were receiving background therapy, the incidence of a clinical response was ...

2. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2414719

A Phase 3 Trial of Telitacicept for Systemic Lupus ... Research Summary · A Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus. Results. Of 433 adults screened, 335 underwent ...

3. ard.bmj.com ard.bmj.com/content/83/4/475

Telitacicept in patients with active systemic lupus erythematosus In conclusion, this phase 2 trial demonstrated the efficacy and acceptable safety profile of telitacicept in patients with SLE. These results support further ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05306574

NCT05306574 | A Study of Telitacicept for the Treatment ... The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE. ... Lupus Erythematosus, ...

5. ir.vorbio.com ir.vorbio.com/news-releases/news-release-details/vor-bio-announces-publication-china-phase-3-study-telitacicept

News Release Trial met primary endpoint achieving statistically significant improvement in disease activity, with 67.1% of patients responding with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12313615/

Efficacy and safety of telitacicept in systemic lupus ... This retrospective cohort study evaluated the therapeutic efficacy and safety profile of telitacicept, a novel dual B-cell-activating factor ...