A Phase 3 interventional study of Telitacicept and Placebo in Systemic Lupus Erythematosus, sponsored by Vor Biopharma. Withdrawn at 4 sites in United States. Open to participants aged 12 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Vor Biopharma · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.
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 development of organ damage and co-morbidities.
Telitacicept is a fully human TACI-Fc fusion protein that targets B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). Blocking the interaction of BLyS and APRIL with their cell membrane receptors (TACI, B-cell maturation antigen (BCMA), and B-cell activating factor receptor (BAFF-R) would inhibit B cell proliferation and maturation, suppresses immune responses and may alleviate autoimmune symptoms.
This is a multicenter, randomized, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of telitacicept added to standard of care (SoC) therapy compared to placebo with SoC therapy in subjects with moderately to severely active SLE.
Moderately to severely active SLE definined by the following:
Exclusion Criteria:
Telitacicept + Standard of Care (SOC)
Biological: Telitacicept
Placebo + Standard of Care (SOC)
Drug: Placebo
Subcutaneous injection
Subcutaneous injection
SLE Responder Index (SRI-4)
Proportion of subjects achieving an SLE Responder Index (SRI-4) response
Time frame: Week 52
SLE Responder Index (SRI-4)
Proportion of subjects achieving an SLE Responder Index (SRI-4) response
Time frame: Week 24
Achieve and sustain a low dose of corticosteriods
Proportion of subjects achieving the target of corticosteroids reduction.
Time frame: Week 52
SLE Responder Index (SRI-4) and sustaining a low dose of corticosteriods
Proportion of patients achieving an SRI-4 response at Week 52, while achieving and maintaining corticosteroids reduction.
Time frame: Week 52
BILAG-based Combined Lupus Assessment (BICLA) Response
Proportion of patients achieving a BILAG-based Combined Lupus Assessment (BICLA) response at Week 52
Time frame: Week 52
Time to Flare
Time to flare assessed by SELENA-SLEDAI Flare Index (SFI) from baseline through Week 52
Time frame: Up to Week 52
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Proportion of patients achieving clinically meaningful improvement in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52
Time frame: Week 52
Plan to share: No
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This study is withdrawn, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic→
Vor Biopharma