Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT05673993
Eligibility Criteria:
Main Inclusion Criteria:
1. Written informed consent provided.
2. Males and females, 18-70 years of age.
3. Fulfilled the classification criteria of pSS according to ACR/EULAR (2016).
4. Anti-SSA antibody tested positive at screening.
5. ESSDAI score ≥ 5 at screening.
Main Exclusion Criteria:
1. Secondary Sjogren's syndrome.
2. Severe organ involvement related to pSS in the opinion of the investigator, including but not limited to a) severe vasculitis (not cutaneous vasculitis) affecting the kidney, gastrointestinal system, cardiac, pulmonary or central nervous system (CNS); b) active CNS or peripheral nervous system involvement requiring high dose corticosteroids; c) severe kidney involvement, e.g. GFR \< 60 ml/min, serum creatinine \> 2 mg/dL, or proteinuria \> 3g/d; d) severe pulmonary involvement, e.g. shortness of breath at rest, FVC \< 60% or DLCO \< 40%; e) muscle diseases requiring high dose corticosteroids; f) lymphoma.
3. Received sodium hyaluronate eye drops, artificial tears or artificial saliva within 7 days prior to screening.
4. Received live vaccine within 28 days prior to randomization.
5. Active hepatitis or history of severe liver diseases.
6. HIV positive.
7. Patients with malignant tumors.
8. Received investigational pharmaceutical within 28 days or 5 half-lives prior to randomization, whichever is longer.
9. Nursing or pregnant female, or male or female who prepared for parenthood during the study.
10. Any condition that, in the opinion of the investigator, makes it unsuitable for the subject to participate, e.g., poorly controlled high blood pressure, diabetes, heart failure or mental illness.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05673993
Study Brief:
Protocol Section:
NCT05673993