Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RC18, RC18-L
Telitacicept · 2 trials · 2 indications
Change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48.
The MG-ADL is an 8-item patient-reported outcome measure assessing MG symptoms and their effects on daily activities. Each item in the scale is scored on a 0 to 3 (0=normal, 3=severe disease) point scale. The total score is the sum of all individual item scores ranging from 0 to 24. Higher scores indicate more severe disability due to MG. A decrease from Baseline score indicates improvement.
| Arm | Type | Description |
|---|---|---|
| Telitacicept | EXPERIMENTAL | Telitacicept |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Telitacicept | BIOLOGICAL | Subcutaneous injection |
| Placebo | DRUG | Subcutaneous injection |
Inclusion Criteria: 1. Male or female aged 18 to 75 years of age (both inclusive) at screening 2. Participants must meet the 2016 American College of Rheumatology (ACR)/EULAR classification criteria for primary Sjogren's Syndrome at the time of screening. 3. ESSDAI ≥5 at screening (score calculated...
Telitacicept is an investigational monoclonal antibody being developed by Vor Biopharma Inc. for neurology indications. It is in Phase 3 clinical development for generalized myasthenia gravis and primary Sjogren's disease. Telitacicept has not been established as an approved therapy in these programs and remains under clinical study.
Telitacicept is being studied as a treatment for generalized myasthenia gravis, a neuromuscular condition. The Phase 3 UPSTREAM MG study, NCT06456580, is evaluating telitacicept in adults with the disease across sites in the United States, Europe, Asia, South America and Australia. The trial is active but no longer recruiting new participants.
Telitacicept targets BLyS and APRIL, two signaling molecules involved in B cell survival and antibody production. By binding both ligands, telitacicept is designed to reduce B cell activity and autoantibody production. This dual BLyS/APRIL targeting is the basis for its study in autoimmune-driven neurological and rheumatologic conditions.
Telitacicept is being developed by Vor Biopharma Inc., which trades under the ticker VOR. The company is advancing the monoclonal antibody through Phase 3 clinical trials in generalized myasthenia gravis and primary Sjogren's disease.
Telitacicept is in Phase 3 clinical development. Two Phase 3 programs are underway: one in generalized myasthenia gravis and one in active primary Sjogren's disease. Telitacicept is investigational and is not an approved product for these indications.
Telitacicept is being evaluated in two Phase 3 trials. NCT06456580, the UPSTREAM MG study, is an active, non-recruiting trial in generalized myasthenia gravis with 191 participants. NCT07404865 is a recruiting, placebo-controlled, double-blind Phase 3 study in active primary Sjogren's disease with 250 participants across the United States and Georgia.