Multicenter Double-blinded Randomized Phase 2a Clinical Trial to Evaluate the Efficacy of SA001 for Dry Eye and Mouth Dryness in the Patients With Primary Sjögren's Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in Tear Break-Up Time(TBUT) from baseline to Day 28 and Day 56
研究概览
简要总结
This is a phase2a, multicenter, double-blind, placebo control, randomized study to investigate the efficacy and safety of SA001 in subjects with pSS. A total of 28 subjects (including dropout rate of 30%) will be randomized in a 1:1:1:1 ratio to receive 3 different doses of SA001 or placebo everyday for 8 weeks.
Screening visit will be performed within 1 to 2 weeks(run-in period) prior to dosing after signing the informed consent form (ICF). During the run-in period, if necessary, subjects will apply artificial tears in the symptomatic eyes according to the dosage of artificial tears. Only subjects who have completed the run-in period and who are determined to be suitable for the study eligibility(inclusion/exclusion) criteria as a result of the screening evaluations are randomized to one of the four groups.
Subjects will receive investigational product start on Day 0 for 8 weeks during the active treatment period. Subjects will visit to the study site on 4 and 8 weeks after starting dosing investigational product.
Subjects will be in this study approximately 12weeks, which includes run-in period of 1 to 2weeks and a safety follow-up period of 2weeks.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 through 80 years
- •Patient who diagnosed with Primary Sjögren's Syndrome(has a score of ≥ 4 when the weights from 5 criteria items are summed) ① Labial salivary gland with focal lymphocytic sialadenitis and focus score of ≥ 1 foci/4 mm2 (weight: 3)
- •② Anti-SSA/Ro-positive (weight: 3)
- •③ Ocular Staining Score ≥ 5 (or van Bijsterveld score ≥ 4) in at least one eye (weight: 1)
- •④ Schirmer's test ≤ 5 mm/5 min in at least one eye (weight: 1)
- •⑤ Unstimulated whole saliva flow rate ≤ 0.1 mL/min (weight: 1)
- •Standard Patient Evaluation of Eye Dryness(SPEED) score ≥ 5
排除标准
- •Secondary Sjögren's Syndrome patient
- •Severe blepharitis caused by Meibomian gland dysfunction
- •Administration of eye drops that may affect efficacy assessment in the past 2 weeks prior to baseline (Steroid, glaucoma, allergy, antibiotic, eye drop gel, Cyclosporine, Diquafosol tetrasodium, etc)
- •New administration or changing the dosage of systemic steroid drugs or immunosuppressant that may affect immune function in the past 4 weeks prior to baseline
- •Administration of oral medication of Tetracycline, Isotretinoin in the past 4 weeks prior to baseline
- •New administration or changing the dosage of Hydroxychloroquine medication in the past 12 weeks prior to baseline
- •Planning to undergo eye surgery(including eyesight correction surgery) during the study period
- •Wearing contact lenses during the study period
- •History of ophthalmic surgery and trauma in the past 6 months prior to signing the ICF
- •Participation in an investigational drug or device trial within 3 months prior to signing the ICF
- •Hypersensitivity to the ingredients of this drug
- •Genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •A woman who has a positive Serum hCG test at the screening visit (Visit 1), or who does not agree to use at least one effective contraceptive method that is medically acceptable
- •Take oral contraceptives during the study period
- •Pregnant or lactating women
- •A history of drug or alcohol abuse
- •Any condition that, in the opinion of the investigator, would inappropriate to participate in the clinical trial
研究组 & 干预措施
Group 1
SA001 Low dose
干预措施: SA001 Low dose (Drug)
Group 2
SA001 Mid dose
干预措施: SA001 Mid dose (Drug)
Group 3
SA001 High dose
干预措施: SA001 High dose (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Tear Break-Up Time(TBUT) from baseline to Day 28 and Day 56
时间窗: Baseline(Day0), Day 28 and Day 56
Change in Ocular Staining Score(OSS) from baseline to Day 28 and Day 56
时间窗: Baseline(Day0), Day 28 and Day 56
Change in Schirmer Test score from baseline to Day 28 and Day 56
时间窗: Baseline(Day0), Day 28 and Day 56
Change in Standard Patient Evaluation of Eye Dryness questionnaire(SPEED) score from baseline to Day 28 and Day 56
时间窗: Baseline(Day0), Day 28 and Day 56
Change in Unstimulated whole saliva flow rate from baseline to Day 56
时间窗: Baseline(Day0) and Day 56
Change in The Xerostomia Inventory(XI) score from baseline to Day 56
时间窗: Baseline(Day0) and Day 56
Change in Anti-SSA/Ro levels from baseline to Day 56
时间窗: Baseline(Day0) and Day 56
Change in the average number of daily use of the artificial tears from baseline to Day 28 and Day 56
时间窗: Baseline(Day0), Day 28 and Day 56
Artificial tears may be applied if necessary.
次要结局
未报告次要终点