WithdrawnPhase 3

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

Stopped: Sponsor business decision

United States0Started 2024-09

Plain-language summary

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.

Age range12 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age 12-70 years at screening.
✓. Has a diagnosis of SLE for at least 6 months prior to the screening visit.
✓. Meets the 2019 EULAR/ACR Classification criteria for SLE.
✓. Moderately to severely active SLE definined by the following:
✓. SELENA SLEDAI total score ≥6 points with clinical SLEDAI score ≥4 points at screening;
✓. BILAG organ system scores of at least 1A or 2B at screening.
✓. Clinical SLEDAI score of ≥4 at Day 0 prior to randomization.
✓. At least one positive serologic parameter within the screening period.

✕. Active lupus nephritis undergoing induction therapy or unstable renal diseases within 12 weeks prior to screening.
✕. Active or unstable neuropsychiatric SLE.
✕. Autoimmune or rheumatic disease other than SLE.
✕. History of arterial or venous thromboembolism or microangiopathy within 12 months prior to screening.
✕. 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.

SLE Responder Index (SRI-4)

Timeframe: Week 52

NCT IDNCT06456567

SponsorVor Biopharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-02