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

Primary Purpose

Primary Sjögren's Syndrome (pSS)

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

SA001 Low dose

SA001 Mid dose

SA001 High dose

Placebo

About this trial

This is an interventional treatment trial for Primary Sjögren's Syndrome (pSS)

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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
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

Sites / Locations

Yonsei University Health System, Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Placebo

Arm Description

SA001 Low dose

SA001 Mid dose

SA001 High dose

Placebo

Outcomes

Primary Outcome Measures

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

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

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

Change in Standard Patient Evaluation of Eye Dryness questionnaire(SPEED) score from baseline to Day 28 and Day 56

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

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

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

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

Artificial tears may be applied if necessary.

Secondary Outcome Measures

Full Information

NCT ID

NCT05269810

First Posted

February 24, 2022

Last Updated

February 16, 2023

Sponsor

Samjin Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05269810

Brief Title

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

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

May 29, 2020 (Actual)

Primary Completion Date

February 25, 2022 (Actual)

Study Completion Date

March 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Samjin Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Sjögren's Syndrome (pSS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

SA001 Low dose

Arm Title

Group 2

Arm Type

Experimental

Arm Description

SA001 Mid dose

Arm Title

Group 3

Arm Type

Experimental

Arm Description

SA001 High dose

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

SA001 Low dose

Intervention Description

3 tablets b.i.d for 8 weeks

Intervention Type

Drug

Intervention Name(s)

SA001 Mid dose

Intervention Description

3 tablets b.i.d for 8 weeks

Intervention Type

Drug

Intervention Name(s)

SA001 High dose

Intervention Description

3 tablets b.i.d for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

3 tablets b.i.d for 8 weeks

Primary Outcome Measure Information:

Title

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

Time Frame

Baseline(Day0), Day 28 and Day 56

Title

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

Time Frame

Baseline(Day0), Day 28 and Day 56

Title

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

Time Frame

Baseline(Day0), Day 28 and Day 56

Title

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

Title

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

Time Frame

Baseline(Day0) and Day 56

Title

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

Time Frame

Baseline(Day0) and Day 56

Title

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

Time Frame

Baseline(Day0) and Day 56

Title

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

Description

Artificial tears may be applied if necessary.

Time Frame

Baseline(Day0), Day 28 and Day 56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kyoung Yul Seo, Ph.D.

Organizational Affiliation

Yonsei University Health System, Severance Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yonsei University Health System, Severance Hospital

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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