NCT05269810

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Samjin Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Sjögren's Syndrome (pSS)

Interventions

Type	Name	Description
DRUG	SA001 Low dose	3 tablets b.i.d for 8 weeks
DRUG	SA001 Mid dose	3 tablets b.i.d for 8 weeks
DRUG	SA001 High dose	3 tablets b.i.d for 8 weeks
DRUG	Placebo	3 tablets b.i.d for 8 weeks

Timeline

• Start date: 2020-05-29
• Primary completion: 2022-02-25
• Completion: 2022-03-21
• First posted: 2022-03-08
• Last updated: 2023-02-17

Locations

1 site across 1 country: South Korea