Clinical trial NCT05269810: Clinical Study to Investigate the Efficacy of Orally Administered SA001 in Patients With Primary Sjögren's Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Sjögren's Syndrome (pSS)
Lead sponsor: Samjin Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-08
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Tear Break-Up Time(TBUT) from baseline to Day 28 and Day 56
timeFrame: Baseline(Day0), Day 28 and Day 56
measure: Change in Ocular Staining Score(OSS) from baseline to Day 28 and Day 56
timeFrame: Baseline(Day0), Day 28 and Day 56
measure: Change in Schirmer Test score from baseline to Day 28 and Day 56
timeFrame: Baseline(Day0), Day 28 and Day 56
measure: 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
measure: Change in Unstimulated whole saliva flow rate from baseline to Day 56
timeFrame: Baseline(Day0) and Day 56
measure: Change in The Xerostomia Inventory(XI) score from baseline to Day 56
timeFrame: Baseline(Day0) and Day 56
measure: Change in Anti-SSA/Ro levels from baseline to Day 56
timeFrame: Baseline(Day0) and Day 56
measure: Change in the average number of daily use of the artificial tears from baseline to Day 28 and Day 56
timeFrame: Baseline(Day0), Day 28 and Day 56
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Yonsei University Health System, Severance Hospital
name: Kyoung Yul Seo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: