Primary Sjögren's Syndrome (pSS)
Conditions
Brief 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.
Interventions
DRUGSA001 Low dose
3 tablets b.i.d for 8 weeks
DRUGSA001 Mid dose
3 tablets b.i.d for 8 weeks
DRUGSA001 High dose
3 tablets b.i.d for 8 weeks
DRUGPlacebo
3 tablets b.i.d for 8 weeks
Sponsors
Samjin Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline(Day0), Day 28 and Day 56 | Artificial tears may be applied if necessary. |
Countries
South Korea
Outcome results
None listed