Clinical Study to Investigate the Efficacy of Orally Administered SA001 in Patients With Primary … (NCT05269810) | Clinical Trial Compass
CompletedPhase 2
Clinical Study to Investigate the Efficacy of Orally Administered SA001 in Patients With Primary Sjögren's Syndrome
South Korea28 participantsStarted 2020-05-29
Plain-language 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.
Who can participate
Age range
19 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Tear Break-Up Time(TBUT) from baseline to Day 28 and Day 56
Timeframe: Baseline(Day0), Day 28 and Day 56
2
Change in Ocular Staining Score(OSS) from baseline to Day 28 and Day 56
Timeframe: Baseline(Day0), Day 28 and Day 56
3
Change in Schirmer Test score from baseline to Day 28 and Day 56
Timeframe: Baseline(Day0), Day 28 and Day 56
4
Change in Standard Patient Evaluation of Eye Dryness questionnaire(SPEED) score from baseline to Day 28 and Day 56
Timeframe: Baseline(Day0), Day 28 and Day 56
5
Change in Unstimulated whole saliva flow rate from baseline to Day 56
Timeframe: Baseline(Day0) and Day 56
6
Change in The Xerostomia Inventory(XI) score from baseline to Day 56
Timeframe: Baseline(Day0) and Day 56
7
Change in Anti-SSA/Ro levels from baseline to Day 56