A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)
- Conditions
- Interventions
- Registration Number
- NCT06456567
- Lead Sponsor
- RemeGen Co., Ltd.
- 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 SLE with diminished health-related quality of life (HRQoL), persistent disease activity, disease flares, intolerance to standard of care (SOC) therapies, and deve...
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 350
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Age 12-70 years at screening.
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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.
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Clinical SLEDAI score of ≥4 at Day 0 prior to randomization.
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At least one positive serologic parameter within the screening period.
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Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo + Standard of Care (SOC) Telitacicept Telitacicept Telitacicept + Standard of Care (SOC)
- Primary Outcome Measures
Name Time Method SLE Responder Index (SRI-4) Week 52 Proportion of subjects achieving an SLE Responder Index (SRI-4) response
- Secondary Outcome Measures
Name Time Method SLE Responder Index (SRI-4) Week 24 Proportion of subjects achieving an SLE Responder Index (SRI-4) response
SLE Responder Index (SRI-4) and sustaining a low dose of corticosteriods Week 52 Proportion of patients achieving an SRI-4 response at Week 52, while achieving and maintaining corticosteroids reduction.
BILAG-based Combined Lupus Assessment (BICLA) Response Week 52 Proportion of patients achieving a BILAG-based Combined Lupus Assessment (BICLA) response at Week 52
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Week 52 Proportion of patients achieving clinically meaningful improvement in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52
Achieve and sustain a low dose of corticosteriods Week 52 Proportion of subjects achieving the target of corticosteroids reduction.
Time to Flare Up to Week 52 Time to flare assessed by SELENA-SLEDAI Flare Index (SFI) from baseline through Week 52
Trial Locations
- Locations (4)
Hemet site
🇺🇸Hemet, California, United States
Menifee site
🇺🇸Menifee, California, United States
Rockford site
🇺🇸Rockford, Illinois, United States
Stafford site
🇺🇸Stafford, Texas, United States