NCT06297213尚未招募1 期
A Single and Repeat Dosing Study of the Safety, Drug Exposure and Clinical Activity of R-2487 in Patients With Sjogren's Syndrome (SS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration
研究概览
简要总结
The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Sjogren's Syndrome.
Patients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Sjogren's Syndrome. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of SS according to American-European Consensus Group Criteria
- •Able to provide informed consent
- •Subjects receiving prednisone (10 mg or less/day) must be on a stable dose for more than 2 weeks
- •All male and female subjects who are biologically capable of having children must agree to use medically acceptable method of birth control for the duration of the study. All female subjects who are biologically capable of having children must have a negative pregnancy test result before administration of investigational product.
- •The use of probiotics prior to study enrollment is accepted; however, during the course of the study, the use of probiotics is forbidden.
排除标准
- •No known active overlapping or associated other autoimmune disease
- •Prior allogenic or autologous bone marrow or organ transplantation
- •Subjects with prior irradiation to the head and neck, including radioactive iodine treatment for hyperthyroidism
- •Subjects who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Subjects who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.
- •Subjects with positive results for human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- •Subjects with active viral, bacterial, or fungal infection, or history of severe opportunistic infection within the preceding 3 months, or COVID-19 infection in the past 3 months
- •Subjects with evidence of active or latent tuberculosis
- •Active infection of the salivary or lacrimal glands
- •Prior immunotherapy, biologics, or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer, prior to the first dose of R-2487 DP
- •Pregnant or breastfeeding women
- •Current clinical findings of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, endocrine, neurological, or cerebral disease with laboratory values as following:
- •Hemoglobin level < 9.0 g/dL
- •Absolute white blood cell (WBC) count of <3.0×109/L (<3000/mm3), or absolute neutrophil count of <1.2×109/L (<1200/mm3), or absolute lymphocyte count of <0.8×109/L (<800/mm3).
- •Thrombocytopenia, defined by platelet count <100×109/L (<100,000/mm3)
- •Chronic kidney disease defined as Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, based on the age appropriate calculation.
- •Proteinuria ≥3+.
- •Total bilirubin (T-bili), aspartate aminotransferase (AST), alanine aminotransferase (ALT) more than 1.5 times upper limit of normal (ULN).
- •Previously diagnosed hepatic cirrhosis (Child Pugh A or higher) or previously diagnosed significant liver fibrosis (> F3)
- •Any form of vaccination in the last 30 days, to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio.
- •Subjects should not receive any of the following medications:
- •Rituximab or belimumab within 6 months prior to Day 1 Abatacept within 3 months prior to Day 1 Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or Mycophenolate mofetil within 2 months prior to Day 1 Etanercept, Anakinra, Immunoglobulin, or blood products within 28 days prior to Day 1
- •Prior immunotherapy, including systemic corticosteroids, such prednisone, biologics, Janus kinase (JAK) inhibitors (such as tofacitinib, or upadacitinib), ozanimod, or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer, prior to Day 0, unless otherwise specified. In the case of cell-depleting therapies, such as B or T cell depletion, cell counts must have recovered to acceptable or baseline levels (use of licensed agents for indications not listed in the package insert is permitted).
研究组 & 干预措施
Open Label
Other
Probiotic
干预措施: R-2487 (Drug)
结局指标
主要结局
Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration
时间窗: Baseline through Week 4
To assess the number of participants with treatment-related adverse events after taking R-2487 (probiotic)
次要结局
- Change in Patient reported general health questionnaire Short Form Health Survey-36(SF-36)(Baseline through week 4)
- Change in disease activity through Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ClinESSDAI)(Baseline through Week 4)
研究者
相似试验
招募中
1 期
R-2487 in Patients With Rheumatoid ArthritisArthritis, RheumatoidNCT05961592Rise Therapeutics LLC73
招募中
1 期
R-3750 in Patients With Mild to Moderate Ulcerative ColitisUlcerative Colitis Chronic MildUlcerative Colitis Chronic ModerateUlcerative Colitis ChronicUlcerative ColitisNCT05666960Rise Therapeutics LLC36
招募中
1 期
R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients With Solid TumorsSolid Tumor, AdultSolid TumorBasal Cell CancerSquamous Cell CancerAdenomaMelanomaNCT06398418Rise Therapeutics LLC33
已完成
不适用
Safety of an Oral Probiotic in Healthy AdultsHealthy AdultsNCT04492631Dose Biosystems Inc.64
招募中
4 期
Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D)IBS - Irritable Bowel SyndromeNCT05509725Lallemand Health Solutions162