Telitacicept for Lupus

Recruiting at 99 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

350 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing telitacicept, a protein that helps reduce overactive immune cells, in patients with active lupus who don't respond well to standard treatments. It works by blocking proteins that help immune cells grow, which can reduce lupus symptoms. Telitacicept is a new treatment that has been approved in China for adults with active 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.

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

Research shows that telitacicept has been effective in treating systemic lupus erythematosus (SLE), including difficult skin symptoms, and has been approved in China for this use. It works by targeting specific proteins that help control immune system activity, and studies are ongoing to explore its use for other conditions. ^{1 2 3 4 5}

Is telitacicept safe for humans?

Telitacicept has been studied for safety in people with systemic lupus erythematosus (SLE) and appears to be well tolerated, meaning it generally does not cause serious side effects. It has received conditional approval in China and fast track designation in the U.S. for treating SLE, indicating that it has shown promise in terms of safety and effectiveness. ^{1 2 3 5 6}

What makes the drug telitacicept unique for treating lupus?

Telitacicept is unique because it is a fusion protein that targets and neutralizes two specific molecules, BLyS and APRIL, which are involved in the survival of B cells that contribute to lupus. This mechanism is different from other treatments and offers a novel approach to managing the disease. ^{1 2 3 6 7}

Eligibility Criteria

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

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

Treatment Details

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.

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)

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 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 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]

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, 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]

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. Japan pubmed.ncbi.nlm.nih.gov

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

4. United States 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. [2022]

5. 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]

6. Spain pubmed.ncbi.nlm.nih.gov

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

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

Telitacicept: First Approval. [2022]