RecruitingPhase 3NCT07404865

Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept in Adult Participants With Active Primary Sjögren's Disease

Sponsor

Vor Biopharma

Enrollment

250 participants

Start Date

Feb 26, 2026

Study Type

INTERVENTIONAL

Conditions

Primary Sjogren's Disease

Summary

Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study is testing a drug called telitacicept for people with primary Sjögren's disease — a condition where the immune system attacks moisture-producing glands, causing dry eyes and dry mouth. Telitacicept is designed to calm overactive immune responses. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with primary Sjögren's disease according to standard 2016 medical criteria - Your disease is active (ESSDAI score of 5 or higher) - You test positive for a specific antibody called anti-SSA/Ro **You may NOT be eligible if...** - You have another autoimmune disease (such as rheumatoid arthritis, lupus, or scleroderma) that could better explain your symptoms - You have severe infections or other conditions that affect the immune system - You are pregnant or planning to become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTelitacicept

Subcutaneous injection

DRUGPlacebo

Subcutaneous injection

Locations(18)

Arizona Arthritis & Rheumatology Associates P.C.

Chandler, Arizona, United States

Arizona Arthritis & Rheumatology Associates P.C.

Flagstaff, Arizona, United States

Arizona Arthritis & Rheumatology Associates, PLLC

Glendale, Arizona, United States

Arizona Arthritis & Rheumatology Associates P.C.

Phoenix, Arizona, United States

Arizona Arthritis & Rheumatology Associates, P.C.

Tucson, Arizona, United States

Wallace Rheumatic Study Center

Beverly Hills, California, United States

Finlay Medical Research Corp

Green Acres, Florida, United States

Chicago Clinical Research Institute Inc

Chicago, Illinois, United States

Willow Rheumatology & Wellness

Willowbrook, Illinois, United States

Accurate Clinical Research, Inc.

Lake Charles, Louisiana, United States

Arthritis and Rheumatology Research Institute, PLLC

Allen, Texas, United States

Accurate Clinical Research

Baytown, Texas, United States

Novel Research LLC

Bellaire, Texas, United States

Precision Comprehensive Clinical Research Solutions

Euless, Texas, United States

Lone Star Arthritis & Rheumatology

Fort Worth, Texas, United States

Accurate Clinical Research, Inc.

Houston, Texas, United States

R&H Clinical Research Inc.

Katy, Texas, United States

Velocity Clinical Research, Waco

Waco, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07404865