Loading clinical trials...

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

COMPLETEDPHASE2

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

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

NCT05269810•Samjin Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Age

19 - 80 years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Locations (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Key Dates

Start Date

May 29, 2020

Primary Completion Date

February 25, 2022

Completion Date

March 21, 2022

Last Updated

February 17, 2023

Enrollment

ACTUAL participants

Conditions

Primary Sjögren's Syndrome (pSS)

Interventions

SA001 Low dose

DRUG

SA001 Mid dose

DRUG

SA001 High dose

DRUG

Placebo

DRUG

Therapeutic Effect of Upadacitinib in Primary Sjögren's Syndrome

NCT06862284

Primary Sjögren's Syndrome (pSS)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions