Clinical Study to Investigate the Efficacy of Orally Administered SA001 in Patients With Primary Sjögren's Syndrome

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

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.

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