clinical study to investigate the efficacy of orally administered sa001 in patients with primary sjögren's syndrome

Conditions: Primary Sjögren's Syndrome (pSS)

Summary: 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.


Eligibility criteria:
inclusion criteria: * 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 exclusion criteria: * 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