Sjogren's Disease
Conditions
Brief summary
To evaluate the efficacy and safety of ONO-4915 in patients with primary Sjogren's disease
Interventions
DRUGONO-4915
Subcutaneous administration
DRUGPlacebo
Subcutaneous administration
Sponsors
Ono Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Patients with EULAR Sjogren's Syn drome Patient Reported Index (ESSPRI) score at Week 24 | up to week 24 | Patient-reported assessment of dryness, fatigue, and pain, each scored from 0 to 10. The total ESSPRI score is calculated as the mean of the three domain scores and ranges from 0 to 10, with higher scores indicating worse symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ESSPRI total score | up to week 32 | Patient-reported assessment of dryness, fatigue, and pain, each scored from 0 to 10. The total ESSPRI score is calculated as the mean of the three domain scores and ranges from 0 to 10, with higher scores indicating worse symptoms. |
| Subjective symptom score of Sjogren's disease | up to week 32 | Each symptom is scored daily on a numerical scale, with higher scores indicating worse symptoms. |
| EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score | up to week 32 | Symptoms are evaluated across 12 organ/system domains using a 4-point scale (0 = no activity to 3 = severe activity). Each domain score is weighted according to its clinical importance, and the weighted scores are summed to yield a total score ranging from 0 to 123, with higher scores indicating greater disease activity. |
| Joint counts | up to week 32 | — |
| Physician's Global Assessment (PGA) score | up to week 32 | Evaluated by physician on a numerical scale. Higher scores indicate worse symptoms. |
| Stimulated salivary secretion rate | up to week 24 | — |
| Unstimulated salivary secretion rate | up to week 24 | — |
| Tear secretion rate | up to week 24 | — |
| Adverse events and adverse reactions | up to week 32 | — |
| Number of participants with abnormal laboratory tests (hematology) | up to week 32 | — |
| 12-lead electrocardiogram (Heart rate) | up to week 24 | — |
| Number of participants with abnormal Chest X-ray tests | up to week 24 | — |
| Body Weight | up to week 32 | — |
| Number of participants with abnormal laboratory tests (Immunological test) | up to week 32 | — |
| Rate of PD-1/CD19 occupancy | up to week 24 | — |
| Serum CXCL13 concentration | up to week 32 | — |
| T-cell markers (immunophenotyping) | up to week 32 | — |
| Anti-SS-A/Ro antibody titer | up to week 32 | — |
| Plasma ONO-4915 concentration | up to week 32 | — |
| Number of Participants with anti-ONO-4915 antibody | up to week 24 | — |
| Anti-SS-B/La antibody titer | up to week 32 | — |
| Anti-centromere antibody titer | up to week 32 | — |
| Antinuclear antibody titer | up to week 32 | — |
| Concentration of Rheumatoid factor | up to week 32 | — |
| ESSPRI domain scores | up to week 32 | Scores for the dryness, pain, and fatigue symptoms comprising the ESSPRI. Higher scores indicate worse symptom severity. |
| ESSPRI responder rate | up to week 32 | — |
| Serum BAFF concentration | up to week 32 | — |
| B-cell markers (immunophenotyping) | up to week 32 | — |
| Number of participants with abnormal laboratory tests (blood biochemistry) | up to week 32 | — |
| Number of participants with abnormal laboratory tests (urinalysis) | up to week 32 | — |
| Number of participants with abnormal laboratory tests (coagulation tests) | up to week 32 | — |
| 12-lead electrocardiogram (PR interval) | up to week 24 | — |
| 12-lead electrocardiogram (RR interval) | up to week 24 | — |
| 12-lead electrocardiogram (QRS duration) | up to week 24 | — |
| 12-lead electrocardiogram (QT interval) | up to week 24 | — |
| 12-lead electrocardiogram (QTcF Interval) | up to week 24 | — |
| Blood Pressure | up to week 32 | — |
| Pulse Rate | up to week 32 | — |
| Body Temperature | up to week 32 | — |
Contacts
CONTACTNorth America Clinical Trial Support Desk
CONTACTInternational Clinical Trial Support Desk
STUDY_DIRECTORProject Leader
Ono Pharmaceutical Co., Ltd.
Outcome results
None listed