What side effects are associated with this type of intervention?

Common treatments for Lupus that inhibit B-cell activity, such as Belimumab and Rituximab, have several known side effects. Belimumab can cause nausea, diarrhea, fever, and infusion reactions, and may increase the risk of infections. Rituximab is associated with infusion reactions, infections, and in rare cases, progressive multifocal leukoencephalopathy (PML). Both treatments require careful monitoring due to their immunosuppressive effects.

What prior FDA approvals exist?

The FDA has approved several treatments for lupus that target B-cell activity. Belimumab (Benlysta) is a notable example, as it inhibits the B-lymphocyte stimulator (BLyS), similar to how Telitacicept targets BAFF and APRIL. Rituximab, although not specifically approved for lupus, is another B-cell depleting therapy used off-label for refractory cases. These treatments aim to reduce the abnormal B-cell activity that characterizes lupus, thereby controlling disease activity and preventing flares.

What other types of research exist?

Promising alternatives to Telitacicept for Lupus patients include Anifrolumab (an interferon receptor antagonist), Belimumab (a BAFF inhibitor), and novel JAK inhibitors like Baricitinib. These treatments offer different mechanisms of action and have shown efficacy in clinical trials for systemic lupus erythematosus.

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Telitacicept for Lupus

Phase 3

Recruiting

Research Sponsored by RemeGen Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

Active and/or severe viral, bacterial or fungal infection

History of malignancy within 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 40 - 52

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, treatments like Telitacicept may cause reactions at injection sites, increase infection risk due to immune system suppression, cause headaches, nausea and possibly affect blood cell counts.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe or active infections.

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I have had cancer within the last 5 years.

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I have active or unstable lupus affecting my brain or kidneys.

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I have an autoimmune disease that is not lupus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 40 - 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 40 - 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 40 - 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Endpoint for Stage 1: SLE Responder Index (SRI-4)

Primary Endpoint for Stage 2: SLE Responder Index (SRI-4)

Secondary study objectives

Key secondary endpoint for Stage 2: Annualized severe flare rate

Lupus erythematosus cell

Adrenal Cortex Hormones

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Telitacicept 240 mgExperimental Treatment1 Intervention

Telitacicept 240 mg + SOC

Group II: Telitacicept 160 mgExperimental Treatment1 Intervention

Telitacicept 160 mg + SOC

Group III: PlaceboPlacebo Group1 Intervention

Placebo + SOC

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Telitacicept

2022

Completed Phase 1

~100

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Lupus treatments often target B-cell activity, which plays a crucial role in the disease's pathogenesis. Telitacicept, for example, inhibits BAFF and APRIL, reducing B-cell survival and activity. This is significant because overactive B-cells produce autoantibodies that attack the body's tissues. Other treatments like rituximab, an anti-CD20 monoclonal antibody, deplete B-cells directly, while belimumab inhibits BAFF, similarly reducing B-cell activity. These mechanisms are vital for lupus patients as they help control the immune system's overactivity, reducing symptoms and preventing organ damage.