Telitacicept for Lupus

Not currently recruiting at 119 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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of telitacicept for individuals with moderately to severely active lupus (SLE), a condition where the immune system attacks its own tissues. Participants will receive either the experimental drug, telitacicept, or a placebo, both alongside standard lupus treatments. Suitable candidates for this trial have had lupus for at least six months, experience significant symptoms, and are already on common lupus medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially bringing a new treatment to market.

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 this trial's treatments are likely to be safe?

Research has shown that telitacicept is generally safe for people with systemic lupus erythematosus (SLE). One study found its safety comparable to a placebo, meaning it did not cause more issues than a non-active treatment. Earlier research indicated that patients taking telitacicept did not experience more serious side effects than those on a placebo, suggesting most people tolerate it well. So far, the side effects have been similar to those from a sugar pill, which is a positive sign for safety. Overall, studies suggest telitacicept is generally safe for treating SLE. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus?

Unlike the standard treatments for lupus, which typically involve medications like corticosteroids or immunosuppressants, Telitacicept offers a novel approach by targeting specific proteins involved in the immune response. Telitacicept is designed to inhibit both the B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which are crucial for the survival and function of B cells that play a key role in lupus. Researchers are excited about this dual-targeting mechanism because it has the potential to more effectively reduce disease activity and improve patient outcomes compared to current therapies.

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 condition where the immune system attacks the body. Studies have found that patients taking telitacicept experienced noticeable improvements in their symptoms compared to those taking a placebo, a harmless pill with no active medicine. In one study, many patients showed improvement over a year of treatment. Another report noted that telitacicept significantly reduced disease activity. These findings suggest that telitacicept could be a helpful option for managing moderate to severe lupus. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for people with moderately to severely active Systemic Lupus Erythematosus (SLE). Participants must have an hSLEDAI score of ≥ 4, a positive serologic test, and be on standard SLE medications like steroids or antimalarials. They should have been diagnosed with SLE at least 6 months ago. Those with recent infections, cancer history within 5 years, severe lupus complications or other autoimmune diseases can't join.

Inclusion Criteria

I have active lupus with a score indicating moderate to severe disease and am on standard treatment.

I have been diagnosed with lupus for at least 6 months.

Exclusion Criteria

I do not have any severe or active infections.

I have had cancer within the last 5 years.

Other protocol defined exclusion criteria may apply

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1 Treatment

Evaluation of efficacy, safety, pharmacokinetics (PK) and PD of telitacicept compared to placebo

24 weeks

Stage 2 Treatment

Multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of telitacicept added to SoC

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Telitacicept

Trial Overview The REMESLE-1 study is testing the effectiveness and safety of Telitacicept in treating SLE. Patients will either receive Telitacicept or a placebo without knowing which one they're getting. The goal is to see if Telitacicept can better manage the symptoms compared to not receiving the active drug.

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)

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 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]

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 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]

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]

In a 52-week study involving patients with systemic lupus erythematosus (SLE), higher baseline levels of biomarkers BLyS and APRIL were linked to better treatment responses to atacicept, with flare rates decreasing significantly from 75.7% in the placebo group to 32.0% in the atacicept 150 mg group.

Increased exposure to atacicept was associated with lower flare rates and greater reductions in immunoglobulin levels and B cell counts, indicating a dose-response relationship that could help identify patients who would benefit most from the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post Hoc Analysis of the Phase II/III APRIL-SLE Study: Association Between Response to Atacicept and Serum Biomarkers Including BLyS and APRIL. Gordon, C., Wofsy, D., Wax, S., 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]

Citations

1. ir.vorbio.com ir.vorbio.com/news-releases/news-release-details/telitacicept-demonstrates-sustained-efficacy-and-favorable

News Release At week 48, patients on telitacicept throughout achieved a -9.8 mean QMG change, while placebo crossover patients achieved -9.3; 94.2% of ...

2. 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 ...

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

A Phase 3 Trial of Telitacicept for Systemic Lupus ... Results. Of 433 adults screened, 335 underwent randomization (167 to the telitacicept group and 168 to the placebo group). At week 52, ...

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

Telitacicept in patients with active systemic lupus erythematosus 16–20 Here we report the efficacy and safety results of this phase 2b clinical trial of telitacicept at a range of doses versus placebo in patients with active ...

5. 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, ...