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

Withdrawn before enrolling · Phase 3 · Has a placebo group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

NCT06456567

Run by

Vor Biopharma

People needed

0

Starts

2024-09-01

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 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.
• 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.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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