Primary Sjögren's Syndrome (pSS)Phase 2NCT05269810
Clinical Study to Investigate the Efficacy of Orally Administered SA001 in Patients With Primary Sjögren's Syndrome
A Phase 2 study testing SA001 Low dose, SA001 Mid dose and SA001 High dose in people with Primary Sjögren's Syndrome (pSS), run by Samjin Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Primary Sjögren's Syndrome (pSS)
- What is being tested?
- SA001 Low dose, SA001 Mid dose and SA001 High dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 May 2020to 21 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul, 03722
About this study
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
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.
Read more
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)
- Being tested
- SA001 Low dose, SA001 Mid dose, SA001 High dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SA001 Low doseDrug
3 tablets b.i.d for 8 weeks
SA001 Mid doseDrug
3 tablets b.i.d for 8 weeks
SA001 High doseDrug
3 tablets b.i.d for 8 weeks
PlaceboDrug
3 tablets b.i.d for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | SA001 Low dose Receives: Drug: SA001 Low dose |
| Group 2 | Experimental | SA001 Mid dose Receives: Drug: SA001 Mid dose |
| Group 3 | Experimental | SA001 High dose Receives: Drug: SA001 High dose |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tear Break-Up Time(TBUT) from baseline to Day 28 and Day 56
Measured: Baseline(Day0), Day 28 and Day 56
Change in Ocular Staining Score(OSS) from baseline to Day 28 and Day 56
Measured: Baseline(Day0), Day 28 and Day 56
Change in Schirmer Test score from baseline to Day 28 and Day 56
Measured: Baseline(Day0), Day 28 and Day 56
Change in Standard Patient Evaluation of Eye Dryness questionnaire(SPEED) score from baseline to Day 28 and Day 56
Measured: Baseline(Day0), Day 28 and Day 56
Change in Unstimulated whole saliva flow rate from baseline to Day 56
Measured: Baseline(Day0) and Day 56
Change in The Xerostomia Inventory(XI) score from baseline to Day 56
Measured: Baseline(Day0) and Day 56
Change in Anti-SSA/Ro levels from baseline to Day 56
Measured: Baseline(Day0) and 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.
Measured: Baseline(Day0), Day 28 and Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start29 May 2020
- Primary completion25 Feb 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren's Syndrome (pSS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samjin Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyoung Yul Seo, Ph.D., Principal investigator, Yonsei University Health System, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269810
- Sponsor's protocol ID
- SA001_04
- Status last verified
- Feb 2023
- First submitted
- 24 Feb 2022
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05269810
- Acronym / sponsor ID
- SA001_04
- Conditions
- Primary Sjögren's Syndrome (pSS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Samjin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2020 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: SA001 Low doseSA001 Low dose |
| Group 2 | Experimental | Drug: SA001 Mid doseSA001 Mid dose |
| Group 3 | Experimental | Drug: SA001 High doseSA001 High dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SA001 Low dose3 tablets b.i.d for 8 weeks | Drug | Group 1 |
| SA001 Mid dose3 tablets b.i.d for 8 weeks | Drug | Group 2 |
| SA001 High dose3 tablets b.i.d for 8 weeks | Drug | Group 3 |
| Placebo3 tablets b.i.d for 8 weeks | Drug | Placebo |
Primary outcome
Change in Tear Break-Up Time(TBUT) from baseline to Day 28 and Day 56
Time frame: Baseline(Day0), Day 28 and Day 56
Change in Ocular Staining Score(OSS) from baseline to Day 28 and Day 56
Time frame: Baseline(Day0), Day 28 and Day 56
Change in Schirmer Test score from baseline to Day 28 and Day 56
Time frame: Baseline(Day0), Day 28 and Day 56
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
Change in Unstimulated whole saliva flow rate from baseline to Day 56
Time frame: Baseline(Day0) and Day 56
Change in The Xerostomia Inventory(XI) score from baseline to Day 56
Time frame: Baseline(Day0) and Day 56
Change in Anti-SSA/Ro levels from baseline to Day 56
Time frame: Baseline(Day0) and Day 56
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyoung Yul Seo, Ph.D. principal investigator
Yonsei University Health System, Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SA001 Low dose, SA001 Mid dose and SA001 High dose in people with Primary Sjögren's Syndrome (pSS), run by Samjin Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tear Break-Up Time(TBUT) from baseline to Day 28 and Day 56 (time frame: Baseline(Day0), Day 28 and Day 56). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.