Primary Sjogren's Disease study: Telitacicept
Official title Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease
ClinicalTrials.gov ID: NCT07404865
What this study is testing
What is Telitacicept?
Telitacicept is an investigational injectable medicine being studied as a potential treatment for primary Sjögren's disease. It is designed to bind the cytokines BLyS and APRIL, blocking their interaction with B‑cell receptors and thereby reducing B‑cell activity.
Also referred to as RC18, RC18‑L.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if telitacicept helps improve symptoms and health in people with active primary Sjögren's disease.
- Who it's for
- The study is looking for adults who have active primary Sjögren's disease.
- What's involved
- Participants will receive telitacicept and visit the clinic for checkups and tests to monitor their health.
- Time commitment
- The study duration and specific visit schedule are not provided in the source text.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or female aged 18 to 75 years of age (both inclusive) at screening
- Participants must meet the 2016 American College of Rheumatology (ACR)/EULAR classification criteria for primary Sjogren's Syndrome at the time of...
- ESSDAI ≥5 at screening (score calculated excluding renal, pulmonary and neurological domains)
- Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)/Anti-Sjogren's Syndrome A (Ro) at the Screening Visit.
You likely can't join if
- Participants who have a systemic autoimmune disease other than Primary Sjogren's Disease, such as rheumatoid arthritis, systemic lupus erythematosus...
- Participants who have another autoimmune disease or inflammatory condition that could interfere with assessment of response of Primary Sjogren's...
- Participants with severe fibromyalgia that could interfere with the assessment of response of Primary Sjogren's Disease to therapy
- Active life-threatening or organ-threatening complications of Primary Sjogren's Disease at the time of screening based on investigator evaluation
- Significant, uncontrolled medical disease in any organ system not related to Primary Sjogren's Disease (e.g., poorly controlled asthma...
The study team makes the final eligibility decision.
Where it is enrolling
- Chandler, Arizona, United States
- Flagstaff, Arizona, United States
- Glendale, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Beverly Hills, California, United States
- Denver, Colorado, United States
- Fort Collins, Colorado, United States
- Tampa, Colorado, United States
- Clearwater, Florida, United States
- Cooper City, Florida, United States
- Green Acres, Florida, United States
- Miami, Florida, United States
- New Port Richey, Florida, United States
- Sarasota, Florida, United States
- South Miami, Florida, United States
- Winter Park, Florida, United States
- Boise, Idaho, United States
- Chicago, Illinois, United States
- Schaumburg, Illinois, United States
+ 25 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chandler, Arizona, United States; Flagstaff, Arizona, United States; Glendale, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Beverly Hills, California, United States and 39 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.