Status:
COMPLETED
Clinical Study to Investigate the Efficacy of Orally Administered SA001 in Patients With Primary Sjögren's Syndrome
Lead Sponsor:
Samjin Pharmaceutical Co., Ltd.
Conditions:
Primary Sjögren's Syndrome (pSS)
Eligibility:
All Genders
19-80 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2022
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05269810
Start Date
May 29 2020
End Date
March 21 2022
Last Update
February 17 2023
Active Locations (1)
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1
Yonsei University Health System, Severance Hospital
Seoul, South Korea, 03722