A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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

Key facts

Study ID

NCT05306574

Run by

Vor Biopharma

People needed

91

Starts

2022-06-20

Expected to finish

2025-01-06

Last updated by the study team

2026-01-09

Who can join

Age: 12 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 defined 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.
• Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.

You may not qualify if…

• 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

Where it is running

• Anniston, Alabama Site — Anniston, Alabama, United States
• Mission Hills Site — Mission Hills, California, United States
• Orange Site — Orange, California, United States
• Thousands Oaks Site — Thousand Oaks, California, United States
• Miami, FL Site — Miami, Florida, United States
• Tampa, Florida Site — Tampa, Florida, United States
• Wheaton, Maryland Site — Wheaton, Maryland, United States
• Grand Blanc Site — Grand Blanc, Michigan, United States
• Baytown Site — Baytown, Texas, United States
• Colleyville, Texas Site — Colleyville, Texas, United States
• Houston Site — Houston, Texas, United States
• Waco Site — Waco, Texas, United States
• Quilmes Site — Quilmes, Buenos Aires, Argentina
• Rosario Site — Rosario, Santa Fe Province, Argentina
• San Miguel de Tucuman Site 1 — San Miguel de Tucumán, Tucumán Province, Argentina
• San Miguel de Tucuman Site 2 — San Miguel de Tucumán, Tucumán Province, Argentina
• Ciudad Autonoma Buenos Aires Site 2 — Ciudad Autonoma Buenos Aires, Argentina
• Cordoba Site — Córdoba, Argentina
• San Juan Site — San Juan, Argentina
• Garran Site — Garran, Austl. Cap. Terr., Australia
• Murdoch Site — Murdoch, Western Australia, Australia
• Pleven Site — Pleven, Bulgaria
• Plovdiv Site — Plovdiv, Bulgaria
• Ruse Site — Rousse, Bulgaria
• Batangas Site — Batangas, Philippines

Full record on ClinicalTrials.gov

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