A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)

Launched by REMEGEN CO., LTD. · Jun 7, 2024

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ClinConnect Summary

The REMESLE-2 clinical trial is studying a new treatment called telitacicept for people with moderately to severely active Systemic Lupus Erythematosus (SLE), a chronic autoimmune disease that can affect various parts of the body. The goal of this study is to see how effective and safe telitacicept is for managing the symptoms of SLE. The trial is currently looking for participants aged 12 to 70 who have been diagnosed with SLE for at least six months and have specific signs of active disease. To qualify, individuals must have a certain level of disease activity and be currently taking at least one standard medication for lupus.

If you or a family member are considering participating, you can expect to undergo screening to determine eligibility, and if accepted, you will receive either the study drug or a placebo (a dummy treatment) for a set period. Throughout the trial, healthcare professionals will closely monitor your health and any side effects. It's important to note that certain conditions, like active kidney problems or other autoimmune diseases, may prevent participation. This study is a chance to contribute to research that could lead to better treatments for SLE in the future.

Gender

ALL

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.