NCT07823790Not yet recruitingPhase 2
ONO-4915 in Patients With Primary Sjogren's Disease
A Phase II Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Study in Patients With Primary Sjogren's Disease to Evaluate the Efficacy and Safety of Subcutaneously Administered ONO-4915
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
To evaluate the efficacy and safety of ONO-4915 in patients with primary Sjogren's disease
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 3 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Feb 2029
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Diseases
- Sjögren's disease
- NCT number
- NCT07823790
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From Oct 2026 to the primary completion date, Feb 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with other concurrent autoimmune diseases
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 74 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.