Status:
TERMINATED
A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)
Lead Sponsor:
Vor Biopharma
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
12-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.
Detailed Description
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease with heterogeneous manifestations and disease course. Despite advances in medical care, there are still significant unmet needs in SL...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2025
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT05306574
Start Date
June 20 2022
End Date
January 6 2025
Last Update
January 9 2026
Active Locations (78)
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1
Anniston, Alabama Site
Anniston, Alabama, United States, 36207
2
Mission Hills Site
Mission Hills, California, United States, 91345
3
Orange Site
Orange, California, United States, 92868
4
Thousands Oaks Site
Thousand Oaks, California, United States, 91360