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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
28
3 tablets b.i.d for 8 weeks
3 tablets b.i.d for 8 weeks
3 tablets b.i.d for 8 weeks
3 tablets b.i.d for 8 weeks
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Change in Tear Break-Up Time(TBUT) from baseline to Day 28 and Day 56
Time frame: Baseline(Day0), Day 28 and Day 56
Change in Ocular Staining Score(OSS) from baseline to Day 28 and Day 56
Time frame: Baseline(Day0), Day 28 and Day 56
Change in Schirmer Test score from baseline to Day 28 and Day 56
Time frame: 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
Time frame: Baseline(Day0), Day 28 and Day 56
Change in Unstimulated whole saliva flow rate from baseline to Day 56
Time frame: Baseline(Day0) and Day 56
Change in The Xerostomia Inventory(XI) score from baseline to Day 56
Time frame: Baseline(Day0) and Day 56
Change in Anti-SSA/Ro levels from baseline to Day 56
Time frame: 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
Artificial tears may be applied if necessary.
Time frame: Baseline(Day0), Day 28 and Day 56
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