ONO-4915 in Patients With Primary Sjogren's Disease
- NCT ID
- NCT07823790
- Registry status
- Not yet recruiting
- Study type
- Not specified in the registry data
- Phase
- Phase 2
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Overview
ClinicalTrials.gov lists this study as Not yet recruiting.
Enrollment: 60 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following eligibility criteria.
Inclusion Criteria:
* Age (at the time of informed consent): \>=18 and \<75 years
* Patients who meet the criteria for primary Sjogren's disease defined by the 2016 ACR/EULAR Classification Criteria for Primary Sjogren's Syndrome
* Patients with positive anti-SS-A/Ro antibody in the screening period
* Patients with ESSPRI score of \>=5 and dry symptom score of \>=5 in the screening period
* Patients with stimulated salivary secretion rate of \>=0.1 mL/min by the Saxon test in the screening period.
* Patients diagnosed with primary Sjogren's disease within 10 years
Exclusion Criteria:
* Patients with other concurrent autoimmune diseases
* Patients who may overlap with the clinical symptoms of primary Sjogren's disease or interfere with the evaluation of the clinical symptoms
* Patients with any disease that may interfere with the evaluation of dry symptoms of primary Sjogren's disease
* Patients with any disease that may interfere with the evaluation of pain of primary Sjogren's disease
* Patients with severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, cardiac, endocrine, neurologic, or cerebral disease unrelated to the primary disease
* Patients with current malignancy or history of malignancy within 5 years before the start of screening
* Patients with active infection
Study locations
No study locations are listed in the registry data.
Study details
- Start date
- October 1, 2026
- Primary completion date
- February 1, 2029
- First posted
- September 16, 2026
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT07823790
- Registry last updated
- September 16, 2026
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT07823790 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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