Purpose of this Study
People in this study will come to the clinic about once a month for up to one year. They will be placed into one of two groups by chance. One group will receive the study medicine, and the other group will receive a placebo, which has no active medicine. Neither the participants nor their doctors will know which treatment they are receiving.
The study medicine is designed to block two proteins called BAFF and APRIL. These proteins can help certain immune cells cause inflammation in people with Sjogren disease. Researchers want to learn if reducing this inflammation can help improve symptoms and if the treatment is safe for patients.
Who Can Participate?
Eligibility
People can join this study if they have Sjogren disease that was diagnosed by a rheumatology doctor and meets accepted medical guidelines for the disease. In addition to having dry eyes and dry mouth, participants must also have inflammation affecting other parts of the body. Researchers are looking for people with more active disease to learn if the study treatment can help reduce inflammation and improve symptoms.
Age Range
18-75
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a medicine called telitacicept for people who have moderate to severe Sjogren disease. Sjogren disease is an autoimmune disease, which means the immune system attacks the body by mistake and causes inflammation and other symptoms.
Telitacicept works by blocking two proteins called BAFF and APRIL that help certain immune cells grow and stay active. Researchers want to learn if this medicine can reduce inflammation and improve symptoms in people with Sjogren disease. The medicine is already approved for treating Sjogren disease in China, and this study will help researchers learn how well it works and how safe it is for people in the United States.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
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
Principal Investigator
Teresa
Tarrant
Protocol Number
PRO00120797
NCT ID
NCT07404865
Phase
III
Enrollment Status
Pending Open to Enrollment