A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Impact of Intravenous RSLV-132 in Participants With Sjögren's Disease With Moderate to Severe Symptom Burden
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 13
- 主要终点
- Assessment of cardinal symptoms of Sjogren's
研究概览
简要总结
The goal of this clinical study is to learn if RSLV-132 improves the symptoms of SS in adults. It will also learn about the safety of RSLV-132. The main questions it aims to answer are:
- Does RSLV-132 improve the cardinal symptoms of Sjogren's including fatigue, dryness and pain?
- Does RSLV-132 improve the tiredness/fatigue caused by Sjogren's?
- What are the blood levels of RSLV-132 over time?
- What is the immune (antibody) response in the body to RSLV-132?
- What is the safety profile of RSLV-132?
Researchers will compare RSLV-132 to a placebo (a look-alike substance that contains no drug) to see if RSLV-132 improves the symptoms of pSS.
Participants will:
Take RSLV-132 or a placebo 13 times over 22 weeks Visit the clinic once every week for the first 2 weeks, then every 2 weeks until the end of treatment and then for a final time 4 weeks later (Day 211) for check-ups, tests and to answer questionnaires about their symptoms Record their symptoms every day on an electronic device
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Providing written informed consent
- •Weight at least 45 kg
- •Meet the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria for pSS
- •Diagnosis in the last 30 years
- •Positive anti-Ro/SSA antibody test
- •Score of 5 or higher on the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) scale and the ESSPRI fatigue scale
- •Of non childbearing potential or of childbearing potential and using highly effective contraceptive measures
排除标准
- •Diagnosis of any active autoimmune disease other than pSS that could affect the efficacy assessments
- •Uncontrolled hypothyroidism or severe fibromyalgia
- •New medications or change in medications in the last 4 weeks for pSS symptoms
- •Receipt of other prohibited medications
- •Apheresis or blood donation
- •Allergic reaction to RSLV-132 or biologic therapy
- •Clinically significant infection in last 30 days
- •Participation in another clinical study
- •Malignancy in last 5 years
- •Positive test for HIV or hepatitis
- •Major surgery in last 30 days or anticipated surgery during the study
- •Pregnancy or breast feeding
- •Laboratory blood tests outside of specified ranges
- •Other medical conditions or medications that would make the participant unsuitable
研究组 & 干预措施
RSLV-132
Intravenous infusions of 10 mg/kg RSLV-132 solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155) for a total of 22 weeks of treatment
干预措施: RSLV-132 (Drug)
Placebo
Intravenous infusions of placebo solution on Days 1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, and 155) for a total of 22 weeks of treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of cardinal symptoms of Sjogren's
时间窗: Measured daily from at least 7 days prior to first dose until 169 days after the first dose
Change from baseline in Sjogren's symptoms on Day 169 assessed using the Sjogren's Symptom Activity Patient Reported Outcome (SSA-PRO) instrument
次要结局
- Tiredness/fatigue assessment(Measured from before the first dose until Day 169)
- Adverse events(From the first dose of Investigational Product until Day 211)
- RSLV-132 immunogenicity(Measured from before the first dose until Day 211)
- RSLV-132 pharmacokinetics(Measured from before the first dose until Day 211)