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Telitacicept

Phase 3

Primary Sjogren's Disease | Monoclonal antibody | Other |Vor Biopharma Inc.|Last Updated: Jun 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment250
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07404865Phase 3 Study of Telitacicept in Active Primary Sjögren's DiseasePHASE3 RECRUITING 250 — — Feb 26, 2026Jan 1, 2029Jun 4, 202626 United States
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Study Endpoints
Primary Endpoints
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48.
Week 48

Change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48.

Secondary Endpoints
To evaluate the efficacy of telitacicept versus placebo at Week 48 in the treatment of adult participants with pSD.
Week 48
To evaluate the efficacy of telitacicept versus placebo in improving glandular function during the trial.
Week 48
To evaluate the effect of telitacicept versus placebo in improving patient-reported outcomes (i.e., how participants feel and function) during the trial.
Week 48
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TelitaciceptEXPERIMENTALTelitacicept
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
TelitaciceptBIOLOGICALSubcutaneous injection
PlaceboDRUGSubcutaneous injection
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites26

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...

Countries:United States
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07404865lastUpdatePostDate: changed
LOWJun 4, 2026NCT07404865lastUpdatePostDate: changed
LOWJun 4, 2026NCT07404865lastUpdatePostDate: changed
LOWJun 4, 2026NCT07404865lastUpdatePostDate: changed
MEDIUMMay 26, 2026NCT07404865primaryCompletionDate: changed
LOWMay 24, 2026NCT07404865studyFirstPostDate: changed