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

NCT05269810 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-02-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Samjin Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyoung Yul Seo, Ph.D. · Yonsei University Health System, Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-29
Primary Completion
2022-02-25
Completion
2022-03-21

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05269810 on ClinicalTrials.gov