NCT07823790尚未招募2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Change from baseline in the Patients with EULAR Sjogren's Syn drome Patient Reported Index (ESSPRI) score at Week 24
研究概览
简要总结
To evaluate the efficacy and safety of ONO-4915 in patients with primary Sjogren's disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
ONO-4915
Experimental
干预措施: ONO-4915 (Drug)
结局指标
主要结局
Change from baseline in the Patients with EULAR Sjogren's Syn drome Patient Reported Index (ESSPRI) score at Week 24
时间窗: 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.
次要结局
- Unstimulated salivary secretion rate(up to week 24)
- Tear secretion rate(up to week 24)
- Adverse events and adverse reactions(up to week 32)
- 12-lead electrocardiogram (Heart rate)(up to week 24)
- Number of participants with abnormal laboratory tests (hematology)(up to week 32)
- ESSPRI total score(up to week 32)
- Subjective symptom score of Sjogren's disease(up to week 32)
- EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score(up to week 32)
- Joint counts(up to week 32)
- Physician's Global Assessment (PGA) score(up to week 32)
- Stimulated salivary secretion 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)
- 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)
研究者
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