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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This phase 3 study tests telitacicept in people with active primary Sjögren's disease. It is for adults ages 18 to 75 who meet the study's disease and blood test requirements.
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18 to 75 years old at screening.
- Meet the 2016 ACR/EULAR medical standards for primary Sjögren's disease.
- Have an ESSDAI disease activity score of at least 5 at screening, not counting kidney, lung, or nerve problems.
- Have a positive blood test for SSA/Ro antibodies, proteins linked to Sjögren's disease.
- Other requirements are listed in the study plan.
Who can't join
- Have another disease in which the immune system attacks the body, such as rheumatoid arthritis or lupus, that better explains most symptoms.
- Have another immune system disease or condition causing inflammation that could make it hard to judge the treatment's effects, such as inflammatory bowel disease or gout.
- Have severe fibromyalgia, a condition that causes widespread pain, that could make it hard to judge the treatment's effects.
- Have Sjögren's complications that threaten life or organs at screening, as judged by the study doctor.
- Have a serious, uncontrolled health problem not caused by Sjögren's that the study doctor believes would prevent participation.
- Other reasons for exclusion are listed in the study plan.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 excluding renal, pulmonary and neurological domains) 4. Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)/Anti-Sjogren's Syndrome A (Ro) at the Screening Visit. Additional inclusion criteria are defined in the protocol Exclusion Criteria: 1. Participants who have a systemic autoimmune disease other than Primary Sjogren's Disease, such as rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis, that can better explain the majority of the symptoms (i.e., secondary Sjogren's Disease) 2. Participants who have another autoimmune disease or inflammatory condition that could interfere with assessment of response of Primary Sjogren's Disease to therapy (e.g., systemic sclerosis, inflammatory bowel disease, gout). 3. Participants with severe fibromyalgia that could interfere with the assessment of response of Primary Sjogren's Disease to therapy 4. Active life-threatening or organ-threatening complications of Primary Sjogren's Disease at the time of screening based on investigator evaluation 5. Significant, uncontrolled medical disease in any organ system not related to Primary Sjogren's Disease (e.g., poorly controlled asthma, cardiovascular disease, accelerated hypertension, major depression, etc.) that in the opinion of the investigator would preclude participant participation. Additional exclusion criteria are defined in the protocol
Study sites (47)
AZ
- Arizona Arthritis & Rheumatology Associates P.C. · Chandler, AZ 85225More trials in Chandler
- Arizona Arthritis & Rheumatology Associates P.C. · Flagstaff, AZ 86001More trials in Flagstaff
- Arizona Arthritis & Rheumatology Associates, PLLC · Glendale, AZ 85306More trials in Glendale
- Arizona Arthritis & Rheumatology Associates P.C. · Phoenix, AZ 85392More trials in Phoenix
- Arizona Arthritis & Rheumatology Associates, P.C. · Tucson, AZ 85704More trials in Tucson
CA
- Wallace Rheumatic Study Center · Beverly Hills, CA 90210More trials in Beverly Hills
CO
- Denver Arthritis Clinic · Denver, CO 80230More trials in Denver
- Tekton Research · Fort Collins, CO 80528More trials in Fort Collins
- Clinical Research of West Florida, Inc. · Tampa, CO 33606More trials in Tampa
FL
- Clinical Research of West Florida - Corporate · Clearwater, FL 33765More trials in Clearwater
- Clinical Research of West Florida, Inc. · Clearwater, FL 33765More trials in Clearwater
- GNP Research · Cooper City, FL 33024More trials in Cooper City
- Finlay Medical Research Corp · Green Acres, FL 33467More trials in Green Acres
- Clever Medical Research · Miami, FL 33126More trials in Miami
- Suncoast Clinical Research Inc. · New Port Richey, FL 34652More trials in New Port Richey
- Sarasota Arthritis Center · Sarasota, FL 34239More trials in Sarasota
- Bioresearch Partners · South Miami, FL 33143More trials in South Miami
- Bioresearch Partner · South Miami, FL 33143More trials in South Miami
- Conquest Research · Winter Park, FL 32789More trials in Winter Park
ID
- St. Luke's Clinic - Rheumatology · Boise, ID 83702More trials in Boise
IL
- Chicago Clinical Research Institute Inc · Chicago, IL 60607More trials in Chicago
- Clinical Investigation Specialist · Schaumburg, IL 60195More trials in Schaumburg
- Willow Rheumatology & Wellness · Willowbrook, IL 60527More trials in Willowbrook
LA
- Accurate Clinical Research, Inc. · Lake Charles, LA 70605More trials in Lake Charles
MA
- Tufts Medical Center · Boston, MA 02111More trials in Boston
MD
- Arthritis and Rheumatism Associates · Rockville, MD 20850More trials in Rockville
MI
- Clinical Research Institute of Michigan, LLC · Saint Clair Shores, MI 48081More trials in Saint Clair Shores
MO
- Kansas City Physician Partners · Kansas City, MO 64151More trials in Kansas City
NC
- Arthritis and Osteoporosis Consultants of the Carolinas · Charlotte, NC 28202More trials in Charlotte
- Duke University Medical Center · Durham, NC 27710More trials in Durham
OK
- Oklahoma Medical Research Foundation · Oklahoma City, OK 73104More trials in Oklahoma City
PA
- Altoona Center for Clinical Research, P.C. · Duncansville, PA 16635More trials in Duncansville
- Clinical Research of Philadelphia, LLC · Philadelphia, PA 19114More trials in Philadelphia
- Rheumatic Disease Associates, Ltd. · Willow Grove, PA 19090More trials in Willow Grove
TX
- Allen Arthritis · Allen, TX 75013More trials in Allen
- Arthritis and Rheumatology Research Institute, PLLC · Allen, TX 75013More trials in Allen
- Amarillo Premier Research, LLC · Amarillo, TX 79124More trials in Amarillo
- Accurate Clinical Research · Baytown, TX 77521More trials in Baytown
- Novel Research LLC · Bellaire, TX 77401More trials in Bellaire
- Helios CR Inc - Dallas, TX · Dallas, TX 75231More trials in Dallas
- Precision Comprehensive Clinical Research Solutions · Euless, TX 76040More trials in Euless
- Lone Star Arthritis & Rheumatology · Fort Worth, TX 76109More trials in Fort Worth
- Accurate Clinical Research, Inc. · Houston, TX 77089More trials in Houston
- Precision Comprehensive Clinical Research Solution · Irving, TX 75061More trials in Irving
- R&H Clinical Research Inc. · Katy, TX 77450More trials in Katy
- Velocity Clinical Research, Waco · Waco, TX 76710More trials in Waco
VA
- Tidewater Clinical Research · Chesapeake, VA 23320More trials in Chesapeake