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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