A Phase 3 interventional study of Telitacicept and Placebo in Systemic Lupus Erythematosus, sponsored by Vor Biopharma. Terminated at 78 sites in 15 countries. 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 Phase 3 study is a 2-stage study to evaluate the efficacy and safety of telitacicept compared to placebo in patients with moderately to severely active SLE while receiving SoC treatment in a global patient population with active SLE disease.
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's enrollment of 91 is above the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Vor Biopharma is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Moderately to severely active SLE defined by the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Telitacicept + Standard of Care (SoC)
Biological: Telitacicept
Placebo + Standard of Care (SoC)
Biological: Placebo
Subcutaneous injection weekly for 52 weeks
Also known as: RC18, RC18-L
Subcutaneous injection weekly for 52 weeks
SLE Responder Index (SRI-4)
Proportion of subjects achieving an SLE Responder Index (SRI-4) response at Week 52
Time frame: Week 52
SLE Responder Index (SRI-4)
Proportion of subjects achieving an SLE Responder Index (SRI-4) response at Week 24
Time frame: Week 24
Achieve and sustain a low dose of corticosteriods
Proportion of subjects achieving the target of corticosteroids reduction through Week 52.
Time frame: Weeks 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: 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
No publications or documents are linked to this record.
Ran from Jun 2022 to primary completion in Jan 2025, 30 months.
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This study is terminated, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Telitacicept
Lupus Erythematosus, Systemic →
Vor Biopharma