Treatment of moderately to severely active systemic lupus erythematosus with telitacicept

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept Compared to Placebo in Patients With Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)

This study is testing if adding a new treatment called telitacicept to regular care can help people with moderately to severely active lupus feel better and improve their quality of life.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 12 Years to 70 Years
• Sex: All
• Sponsor: RemeGen Co., Ltd. (Industry-sponsored)
• Locations: 4 sites (Hemet, California and 3 other locations)
• Trial ID: NCT06456567 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of telitacicept, a TACI-Fc fusion protein, in patients with moderately to severely active systemic lupus erythematosus (SLE). It is a multicenter, randomized, double-blind, placebo-controlled phase 3 trial that compares telitacicept added to standard of care therapy against a placebo with standard of care. The study aims to address significant unmet needs in SLE, including persistent disease activity and intolerance to standard therapies. Participants will be monitored for improvements in disease symptoms and overall health-related quality of life.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12-70 with a diagnosis of SLE for at least 6 months and exhibiting moderately to severely active disease.

Not a fit: Patients with active lupus nephritis undergoing induction therapy or those with unstable neuropsychiatric SLE may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of systemic lupus erythematosus and enhance patients' quality of life.

How similar studies have performed: Other studies have shown promise in targeting B cell pathways for SLE treatment, making this approach a potentially valuable addition to existing therapies.

Eligibility criteria

Inclusion Criteria:

1. Age 12-70 years at screening.
2. Has a diagnosis of SLE for at least 6 months prior to the screening visit.
3. Meets the 2019 EULAR/ACR Classification criteria for SLE.
4. Moderately to severely active SLE definined by the following:

   1. SELENA SLEDAI total score ≥6 points with clinical SLEDAI score ≥4 points at screening;
   2. BILAG organ system scores of at least 1A or 2B at screening.
5. Clinical SLEDAI score of ≥4 at Day 0 prior to randomization.
6. At least one positive serologic parameter within the screening period.
7. Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.

Exclusion Criteria:

1. Active lupus nephritis undergoing induction therapy or unstable renal diseases within 12 weeks prior to screening.
2. Active or unstable neuropsychiatric SLE.
3. Autoimmune or rheumatic disease other than SLE.
4. History of arterial or venous thromboembolism or microangiopathy within 12 months prior to screening.
5. History of non-SLE disease requiring treatment with oral or parenteral. glucocorticosteroids for more than a total of 2 weeks within the last 24 weeks prior to screening.

Where this trial is running

Hemet, California and 3 other locations

• Hemet site — Hemet, California, United States (Recruiting)
• Menifee site — Menifee, California, United States (Recruiting)
• Rockford site — Rockford, Illinois, United States (Recruiting)
• Stafford site — Stafford, Texas, United States (Recruiting)

Study contacts

• Study coordinator: RemeGen

Conditions Systemic Lupus Erythematosus; SLE