Clinical Study to Investigate the Efficacy of Orally Admi... | NCT05269810

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Experimental	SA001 Low dose	Drug: SA001 Low dose
Group 2	Experimental	SA001 Mid dose	Drug: SA001 Mid dose
Group 3	Experimental	SA001 High dose	Drug: SA001 High dose
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
SA001 Low dose	Drug	3 tablets b.i.d for 8 weeks	Group 1
SA001 Mid dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Tear Break-Up Time(TBUT) from baseline to Day 28 and Day 56		Baseline(Day0), Day 28 and Day 56
Change in Ocular Staining Score(OSS) from baseline to Day 28 and Day 56		Baseline(Day0), Day 28 and Day 56
Change in Schirmer Test score from baseline to Day 28 and Day 56		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		Baseline(Day0), Day 28 and Day 56
Change in Unstimulated whole saliva flow rate from baseline to Day 56		Baseline(Day0) and Day 56
Change in The Xerostomia Inventory(XI) score from baseline to Day 56		Baseline(Day0) and Day 56
Change in Anti-SSA/Ro levels from baseline to Day 56		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.	Baseline(Day0), Day 28 and Day 56

Eligibility Module

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