NCT03627065已完成2 期
An Open-Label Phase 2 Study of INCB050465 in Participants With Primary Sjögren's Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Proportion of Participants With a 1 Point or Greater Change on the Salivary Gland Ultrasound (SGUS) Score for Parotid and Submandibular Glands
研究概览
简要总结
The purpose of this study is to assess the impact of parsaclisib on the signs and symptoms of Sjögren's syndrome (SS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary SS diagnosed according to the revised American-European Consensus Group (AECG) criteria.
- •Minimum score of 2 on the SGUS score for parotid and submandibular glands.
- •EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥
- •Positive serum titers of anti-SS-A and/or anti-SS-B antibodies.
- •Symptomatic oral dryness score of at least 5 on patient questionnaire.
- •Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
排除标准
- •Diagnosis of secondary SS according to the revised AECG criteria (eg, the presence of a previously diagnosed or a present diagnosis of rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, mixed connective tissue disease, polymyositis, dermatomyositis, immunoglobulin G4-related disorder, sarcoidosis, or any other defined autoimmune rheumatologic disorder).
- •Concurrent conditions and history of other diseases per protocol-defined criteria.
- •Positive test results for tuberculosis (TB) from the QuantiFERON-TB Gold test or T-spot.TB test.
- •Positive serology test results for HIV antibody, hepatitis B surface antigen, hepatitis B surface antigen antibody, HBV core antibody, or HCV (HCV antibody with positive HCV-RNA).
- •Severely impaired liver function (Child-Pugh Class C).
- •Prior or ongoing therapy with protocol-defined drugs.
- •Receipt of any live vaccine in the 30 days before screening.
- •No major surgery within 30 days before screening. Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
- •Current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the dose regimen and study evaluations.
- •Laboratory values at screening outside the protocol-defined ranges.
研究组 & 干预措施
Parsaclisib
Experimental
干预措施: Parsaclisib (Drug)
结局指标
主要结局
Proportion of Participants With a 1 Point or Greater Change on the Salivary Gland Ultrasound (SGUS) Score for Parotid and Submandibular Glands
时间窗: Week 4 and Week 12
The SGUS is a combination of the scores of the 4 salivary glands (2 parotid and 2 submandibular) each gland is scored on a 5-point scale (0 to 4; 4 being more severe), with the maximum total score being 16.
次要结局
- Number of Participants With Treatment-emergent Adverse Events(Up to 21 weeks)
- Change From Baseline in Salivary CXCL13 Levels(Baseline, Week 4 and Week 12)
- Change in EULAR Sjögren's Syndrome Patient Reported Index(Weeks 4, 8, and 12)
- Change in PROMIS Fatigue Short Form(Weeks 4, 8, and 12)
- Percentage Change in PROMIS Fatigue Short Form(Weeks 4, 8, and 12)
- Percentage Change in European Quality of Life 5 Dimensions Questionnaire(Weeks 4, 8, and 12)
- Change in Whole Salivary Flow(Baseline, Weeks 4, 8, and 12)
- Change in Symptom Scores for Dryness(Weeks 4, 8, and 12.)
- Female Participants Only : Change in Female Sexual Function Index(Weeks 4, 8, and 12)
- Percentage Change in Symptom Scores for Dryness(Weeks 4, 8, and 12.)
- Percentage Change in Whole Salivary Flow(Baseline, Weeks 4, 8, and 12)
- Percentage Change in EULAR Sjögren's Syndrome Patient Reported Index(Weeks 4, 8, and 12)
- Change in European Quality of Life 5 Dimensions Questionnaire(Weeks 4, 8, and 12)
- Change in EULAR Sjögren's Syndrome Disease Activity Index(Week 12)
- Patient Global Impression of Change Questionnaire(Baseline, Weeks 4, 8, and 12)
- Percentage Change in EULAR Sjögren's Syndrome Disease Activity Index(Week 12)
- Female Participants Only : Percentage Change in Female Sexual Function Index(Weeks 4, 8, and 12)
研究者
研究点 (4)
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