This study is looking to evaluate the efficacy of the drug, telitacicept, compared to no drug for the treatment of active Sjögren’s Disease.
UPSTREAM SjD
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
Autoimmune rheumatic disorders, Sjogren's syndrome
All genders
18-75
Recruiting now
Overview
Principal Investigator: Steven Vlad, MD
Contact Us
Lainey Mullen/Nikitha Palthyavath (nikitha.palthyavath@tuftsmedicine.org)
Study details
Inclusion Criteria
- Participants must be diagnosed with primary Sjogren's Syndrome.
- Female of childbearing potential (WOCBP) must use highly effective methods of contraception throughout their study participation and for at least 4 months following the last administration of the study medication.
Exclusion Criteria
- Participants who have a systemic autoimmune disease other than pSD, such as RA, SLE, or systemic sclerosis, that can better explain the majority of the symptoms (i.e., secondary Sjögren’s disease).
- Participants with severe fibromyalgia that could interfere with the assessment of response of pSD to therapy.
- Pregnant or breastfeeding females, and/or females who intend to become pregnant anytime from initiation of screening through 4 months after the last dose of the study medication.
Study Requirements
The length of participation for this study will be 60 weeks: 4-week screening, 48-week double-blind treatment period, and an 8-week follow up period. There will be a maximum of 29 in person visits, but for those who choose to administer the study drug at home there will be 17 in person visits. There will be blood collected at these 17 visits. Other study activities will include questionnaires, saliva collection, physical exams, vital signs, and ECGs.