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Completed

NCT Number: NCT05269810

Clinical Study to Investigate the Efficacy of Orally Administered SA001 in Patients With Primary Sjögren's Syndrome

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.

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Key information

Conditions

Primary Sjögren's Syndrome (pSS)

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yonsei University Health System, Severance Hospital

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SA001 Low dose

Drug

3 tablets b.i.d for 8 weeks

SA001 Mid dose

Drug

3 tablets b.i.d for 8 weeks

SA001 High dose

Drug

3 tablets b.i.d for 8 weeks

Placebo

Drug

3 tablets b.i.d for 8 weeks

Primary outcomes

  1. Change in Tear Break-Up Time(TBUT) from baseline to Day 28 and Day 56

    Time frame: Baseline(Day0), Day 28 and Day 56

  2. Change in Ocular Staining Score(OSS) from baseline to Day 28 and Day 56

    Time frame: Baseline(Day0), Day 28 and Day 56

  3. Change in Schirmer Test score from baseline to Day 28 and Day 56

    Time frame: 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

    Time frame: Baseline(Day0), Day 28 and Day 56

  5. Change in Unstimulated whole saliva flow rate from baseline to Day 56

    Time frame: Baseline(Day0) and Day 56

  6. Change in The Xerostomia Inventory(XI) score from baseline to Day 56

    Time frame: Baseline(Day0) and Day 56

  7. Change in Anti-SSA/Ro levels from baseline to Day 56

    Time frame: Baseline(Day0) and Day 56

  8. Change in the average number of daily use of the artificial tears from baseline to Day 28 and Day 56

    Time frame: Baseline(Day0), Day 28 and Day 56

    Artificial tears may be applied if necessary.

Sponsors and collaborators

Lead sponsor

Samjin Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2022
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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