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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

Summary

This trial will test whether telitacicept is safe and effective in treating 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Endpoint for Stage 1: SLE Responder Index (SRI-4)
Primary Endpoint for Stage 2: SLE Responder Index (SRI-4)
Secondary outcome measures
Key secondary endpoint for Stage 2: Annualized severe flare rate
Lupus erythematosus cell
Adrenal Cortex Hormones

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

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.

Find a Location

Who is running the clinical trial?

RemeGen Co., Ltd.Lead Sponsor
77 Previous Clinical Trials
10,308 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05306574 — Phase 3
Lupus Research Study Groups: Telitacicept 160 mg, Placebo, Telitacicept 240 mg
Lupus Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05306574 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05306574 — Phase 3
~104 spots leftby Jun 2025