RecruitingPhase 3

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

CA

CO

FL

ID

IL

LA

MA

MD

MI

MO

NC

OK

PA

TX

VA