Primary Sjögren's Syndrome (pSS)Phase 2NCT07852234
Exploratory Study on the Efficacy and Safety of Low-Dose Blinatumomab in the Treatment of Moderate to Severe Primary Sjögren's Syndrome
A Phase 2 study testing Blinatumomab and background treatment in people with Primary Sjögren's Syndrome (pSS), run by Beijing Tongren Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if blinatumomab works to treat moderate-to-severe primary Sjögren's Syndrome. It will also learn about the safety of low-dose blinatumomab. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Sjögren's Syndrome (pSS)
- What is being tested?
- Blinatumomab and background treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2026to 1 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who voluntarily agree to comply with the study protocol and provide written informed consent.
- Male or female participants aged 18 to 70 years.
- Diagnosis of primary Sjögren's syndrome according to the 2016 ACR/EULAR classification criteria.
- Positive anti-SSA antibody at screening.
- Moderate-to-severe active primary Sjögren's syndrome at screening, defined as an EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score of ≥5.
- Inadequate response or intolerance to conventional treatment, defined as having received at least one immunomodulatory therapy, including glucocorticoids, cyclophosphamide, antimalarial drugs, azathioprine, or biologic agents, for more than 6 months before screening, with unsatisfactory disease control based on ESSDAI or other clinical assessments, or recurrence of active disease after an initial treatment response.
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- Diagnosis of dry eye disease according to the 2024 Chinese Expert Consensus on the Clinical Diagnosis and Treatment of Dry Eye.
- Moderate-to-severe dry eye disease at screening.
- Laboratory values meeting all of the following requirements:
- Absolute lymphocyte count ≥0.5 × 10⁹/L
- Peripheral blood CD19+ B-cell count ≥25 cells/µL
- Absolute neutrophil count ≥1.0 × 10⁹/L
- Hemoglobin ≥8 g/dL
- Platelet count ≥75 × 10⁹/L
- Total bilirubin ≤1.5 × upper limit of normal (ULN), except for participants with confirmed Gilbert syndrome
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0 × ULN
- Estimated glomerular filtration rate ≥30 mL/min/1.73 m², calculated using the CKD-EPI equation
- Both eyes will undergo study-related examinations and treatment.
Who cannot join
- Secondary Sjögren's syndrome.
- Severe cardiovascular, hepatic, renal, respiratory, endocrine, or malignant disease, or uncontrolled acute or chronic infection.
- Active and severe central nervous system manifestations related to Sjögren's syndrome.
- History of stroke, epilepsy, dementia, Parkinson's disease, ataxia, cerebellar disease, psychosis, paresis, aphasia, or any other neurological condition that, in the investigator's judgment, may place the participant at excessive risk or interfere with study assessments.
- Active ocular infection.
- Other severe ocular diseases or ocular trauma diagnosed within 6 months before enrollment, including glaucoma, uveitis, retinal disease, chemical injury, or thermal burns.
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- Ocular surgery, including cataract surgery, within 6 months before enrollment.
- Use of other eye drops that may affect the study outcomes.
- Participation in another interventional clinical study.
- Pregnancy or breastfeeding, or plans to become pregnant during the study period.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730
Bowen Wang, PhD, +86 15989006980, sysuwangbowen@126.com
About this study
The goal of this clinical trial is to learn if blinatumomab works to treat moderate-to-severe primary Sjögren's Syndrome. It will also learn about the safety of low-dose blinatumomab. The main questions it aims to answer are:
Is low-dose blinatumomab more effective in patients with moderate-to-severe primary Sjögren's Syndrome who have an inadequate response or intolerance to conventional treatment? How does blinatumomab affect B cells, antibody levels, and the immune system in these participants?
Read more
Researchers will compare background treatment plus low-dose Blinatumomab with background treatment only to see if low-dose Blinatumomab works to treat moderate-to-severe primary Sjögren's Syndrome.
Participants will:
Receive background treatment for 24 weeks, including hydroxychloroquine 400 mg each day, methylprednisolone 8 mg each day, and sodium hyaluronate eye drops 4 times each day.
If assigned to the blinatumomab group, receive blinatumomab by continuous intravenous infusion for 5 days during week 1 and again for 5 days during week 3. The dose will be 9 micrograms per day.
Attend regular follow-up visits for clinical assessments, laboratory tests, and monitoring of treatment effectiveness and safety.
- Conditions
- Primary Sjögren's Syndrome (pSS)
- Being tested
- Blinatumomab, background treatment
- Keywords
- Primary Sjögren's Syndrome, Blinatumomab for Injection, Dry eye disease
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
Participants will receive low-dose, short-course blinatumomab treatment. The dosing regimen is as follows:
- First cycle: blinatumomab 9 μg/day by continuous intravenous infusion for 5 consecutive days, for a total dose of 45 μg.
- Second cycle: the same dose and administration schedule will be repeated 1 week later.
background treatmentDrug
All the participants will receive background treatment for 24 weeks. The background treatment includes: (1) hydroxychloroquine, 400 mg/day; (2) methylprednisolone, 8 mg/day; and (3) sodium hyaluronate eye drops, 4 times/day.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Participants will receive background treatment alone for 24 weeks and will not receive blinatumomab. The background treatment includes: (1) hydroxychloroquine, 400 mg/day; (2) methylprednisolone, 8 mg/day; and (3) sodium hyaluronate eye drops, 4 times/day. Receives: Drug: background treatment |
| Experimental group | Experimental | In addition to the same background treatment as the control group, participants will receive low-dose, short-course blinatumomab treatment in the Department of Rheumatology and Immunology. The dosing regimen is as follows:
1. First cycle: blinatumomab 9 μg/day by continuous intravenous infusion for 5 consecutive days, for a total dose of 45 μg.
2. Second cycle: the same dose and administration schedule will be repeated 1 week later. Receives: Drug: Blinatumomab; Drug: background treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
NEI corneal fluorescein staining score
Corneal epithelial damage will be assessed using the National Eye Institute (NEI) corneal fluorescein staining scale. Each cornea is divided into five regions, and each region is scored from 0 to 3. The total score ranges from 0 to 15, with higher scores indicating more severe corneal epithelial damage. The outcome is calculated as the Week 24 total score minus the baseline score. A decrease of 3 points or more from baseline is defined as a response.
Measured: Baseline and Week 24
ESSDAI score
Systemic disease activity will be assessed using the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI). The ESSDAI evaluates disease activity across 12 organ or system domains and has a total score ranging from 0 to 123, with higher scores indicating greater disease activity. The outcome is calculated as the Week 24 total score minus the baseline score. A decrease of 3 points or more from baseline is defined as a response.
Measured: Baseline and Week 24
Secondary outcomes (17)
NEI score at follow-up visits
Corneal epithelial damage will be assessed using the National Eye Institute corneal fluorescein staining scale. The total score ranges from 0 to 15, with higher scores indicating more severe corneal epithelial damage. Changes from baseline will be assessed at each prespecified follow-up visit.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, and 20
OSDI score
Dry eye symptoms and their effects on visual function and quality of life will be assessed using the 12-item Ocular Surface Disease Index (OSDI). The total score ranges from 0 to 100, with higher scores indicating more severe symptoms and greater impairment. Changes from baseline will be assessed at each follow-up visit.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
FBUT
Tear film stability will be assessed using fluorescein tear film break-up time (FBUT). FBUT is measured in seconds from eye opening until the first break in the fluorescein-stained tear film is observed. Measurements will be repeated for each eye and averaged according to the study protocol. Changes from baseline will be assessed at each follow-up visit.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
Schirmer I test
Tear secretion will be assessed using the Schirmer I test without topical anesthesia. A standard filter paper strip is placed in the lower conjunctival sac, and the length of wetting is measured in millimeters after 5 minutes. Changes from baseline will be assessed at each follow-up visit.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
NIBUT
Tear film stability will be assessed using non-invasive tear film break-up time (NIBUT) measured with an ocular surface analyzer. The instrument records the time from completion of a blink to the first detected tear film break. Measurements are generally repeated three times and averaged. Changes from baseline will be assessed at each follow-up visit.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
Tear meniscus height
Tear secretion and distribution will be assessed by measuring lower tear meniscus height using an ocular surface analyzer. The upper and lower boundaries of the lower tear meniscus beneath the central pupil are identified, and tear meniscus height is calculated in millimeters. Changes from baseline will be assessed at each follow-up visit.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
Tear film lipid layer thickness
Tear film lipid layer thickness will be measured using an ocular surface analyzer to assess meibomian gland-related tear film function. Lipid layer thickness is quantified using interference color units, with 1 interference color unit corresponding to approximately 1 nm. Changes from baseline will be assessed at each follow-up visit.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
Incomplete blink rate
Blinking behavior will be assessed using an ocular surface analyzer. The incomplete blink rate is calculated as the number of incomplete blinks divided by the total number of blinks during the observation period and expressed as a percentage. Changes from baseline will be assessed at each follow-up visit.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
ESSDAI at follow-up visits
Systemic disease activity will be assessed using the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), which evaluates 12 organ or system domains. Higher scores indicate greater disease activity. Changes from baseline will be assessed at prespecified follow-up visits.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, and 20
ESSPRI
Patient-reported symptoms will be assessed using the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI). The ESSPRI evaluates dryness, fatigue, and pain on 0-to-10 numeric rating scales. The total score is the average of the three domain scores, with higher scores indicating more severe symptoms. Changes from baseline will be assessed at each follow-up visit.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
MFI-20
Fatigue will be assessed using the 20-item Multidimensional Fatigue Inventory (MFI-20), which includes general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. The total score ranges from 20 to 100, with higher scores indicating greater fatigue. Changes from baseline will be assessed at each follow-up visit.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
Unstimulated salivary flow rate
Salivary gland function will be assessed by measuring unstimulated whole salivary flow. Participants will collect saliva at rest for 15 minutes, and the salivary flow rate will be calculated in milliliters per minute. Changes from baseline will be assessed at each follow-up visit.
Measured: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
Autoantibody titers
Serum autoantibodies, including anti-SSA/Ro, anti-SSB/La, anti-dsDNA, anti-Sm, anti-RNP, antinuclear antibodies (ANA), and antineutrophil cytoplasmic antibodies (ANCA), will be measured. Changes in antibody titers from baseline will be assessed. The proportion of participants whose antibody status changes from positive to negative will also be evaluated.
Measured: Baseline and Weeks 4, 12, and 24
Immunoglobulin levels
Serum immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) concentrations will be measured to assess changes in humoral immune status. Changes from baseline will be evaluated, with particular attention to changes in IgG levels.
Measured: Baseline and Weeks 2, 4, 12, and 24
Peripheral blood lymphocyte subsets
Peripheral blood lymphocyte subsets will be assessed by flow cytometry. Absolute counts of lymphocyte subsets and detailed B-cell subsets will be measured to evaluate the effects of treatment on B cells and T cells.
Measured: Baseline and Weeks 2, 4, 12, and 24
BCR/TCR repertoire
B-cell receptor (BCR) and T-cell receptor (TCR) repertoires will be assessed by high-throughput sequencing of lymphocytes isolated from peripheral blood. Changes in immune repertoire characteristics at follow-up visits will be compared with baseline as an exploratory assessment of treatment effects on adaptive immunity.
Measured: Baseline and Weeks 4, 12, and 24
Adverse events
Safety will be assessed by recording adverse events (AEs), serious adverse events (SAEs), adverse events leading to treatment discontinuation, clinically significant laboratory abnormalities, electrocardiogram abnormalities, and changes in vital signs. Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA).
Measured: From baseline through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start25 Sep 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
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.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinyuan,MD, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852234
- Sponsor's protocol ID
- TREC2026-KY238
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Efficacy and Safety of Low-Dose Blinatumomab in the Treatment of Moderate to Severe Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT07852234
- Acronym / sponsor ID
- TREC2026-KY238
- Conditions
- Primary Sjögren's Syndrome (pSS)
- Keywords
- Primary Sjögren's Syndrome, Blinatumomab for Injection, Dry eye disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 1 Oct 2026 (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.
The goal of this clinical trial is to learn if blinatumomab works to treat moderate-to-severe primary Sjögren's Syndrome. It will also learn about the safety of low-dose blinatumomab. The main questions it aims to answer are:
Is low-dose blinatumomab more effective in patients with moderate-to-severe primary Sjögren's Syndrome who have an inadequate response or intolerance to conventional treatment? How does blinatumomab affect B cells, antibody levels, and the immune system in these participants?
Researchers will compare background treatment plus low-dose Blinatumomab with background treatment only to see if low-dose Blinatumomab works to treat moderate-to-severe primary Sjögren's Syndrome.
Participants will:
Receive background treatment for 24 weeks, including hydroxychloroquine 400 mg each day, methylprednisolone 8 mg each day, and sodium hyaluronate eye drops 4 times each day.
If assigned to the blinatumomab group, receive blinatumomab by continuous intravenous infusion for 5 days during week 1 and again for 5 days during week 3. The dose will be 9 micrograms per day.
Attend regular follow-up visits for clinical assessments, laboratory tests, and monitoring of treatment effectiveness and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: background treatmentParticipants will receive background treatment alone for 24 weeks and will not receive blinatumomab. The background treatment includes: (1) hydroxychloroquine, 400 mg/day; (2) methylprednisolone, 8 mg/day; and (3) sodium hyaluronate eye drops, 4 times/day. |
| Experimental group | Experimental | Drug: Blinatumomab, Drug: background treatmentIn addition to the same background treatment as the control group, participants will receive low-dose, short-course blinatumomab treatment in the Department of Rheumatology and Immunology. The dosing regimen is as follows: 1. First cycle: blinatumomab 9 μg/day by continuous intravenous infusion for 5 consecutive days, for a total dose of 45 μg. 2. Second cycle: the same dose and administration schedule will be repeated 1 week later. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Participants who voluntarily agree to comply with the study protocol and provide written informed consent.
- Male or female participants aged 18 to 70 years.
- Diagnosis of primary Sjögren's syndrome according to the 2016 ACR/EULAR classification criteria.
- Positive anti-SSA antibody at screening.
- Moderate-to-severe active primary Sjögren's syndrome at screening, defined as an EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score of ≥5.
Key exclusion criteria (11 listed)
- Secondary Sjögren's syndrome.
- Severe cardiovascular, hepatic, renal, respiratory, endocrine, or malignant disease, or uncontrolled acute or chronic infection.
- Active and severe central nervous system manifestations related to Sjögren's syndrome.
- History of stroke, epilepsy, dementia, Parkinson's disease, ataxia, cerebellar disease, psychosis, paresis, aphasia, or any other neurological condition that, in the investigator's judgment, may place the participant at excessive risk or interfere with study assessments.
- Active ocular infection.
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 |
|---|---|---|
| BlinatumomabParticipants will receive low-dose, short-course blinatumomab treatment. The dosing regimen is as follows: 1. First cycle: blinatumomab 9 μg/day by continuous intravenous infusion for 5 consecutive days, for a total dose of 45 μg. 2. Second cycle: the same dose and administration schedule will be repeated 1 week later. | Drug | Experimental group |
| background treatmentAll the participants will receive background treatment for 24 weeks. The background treatment includes: (1) hydroxychloroquine, 400 mg/day; (2) methylprednisolone, 8 mg/day; and (3) sodium hyaluronate eye drops, 4 times/day. | Drug | Control group, Experimental group |
Primary outcome
NEI corneal fluorescein staining score
Time frame: Baseline and Week 24
Corneal epithelial damage will be assessed using the National Eye Institute (NEI) corneal fluorescein staining scale. Each cornea is divided into five regions, and each region is scored from 0 to 3. The total score ranges from 0 to 15, with higher scores indicating more severe corneal epithelial damage. The outcome is calculated as the Week 24 total score minus the baseline score. A decrease of 3 points or more from baseline is defined as a response.
ESSDAI score
Time frame: Baseline and Week 24
Systemic disease activity will be assessed using the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI). The ESSDAI evaluates disease activity across 12 organ or system domains and has a total score ranging from 0 to 123, with higher scores indicating greater disease activity. The outcome is calculated as the Week 24 total score minus the baseline score. A decrease of 3 points or more from baseline is defined as a response.
17 secondary outcomes
NEI score at follow-up visits
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, and 20
OSDI score
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
FBUT
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
Schirmer I test
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
NIBUT
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
Tear meniscus height
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
Tear film lipid layer thickness
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
Incomplete blink rate
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
ESSDAI at follow-up visits
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, and 20
ESSPRI
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
MFI-20
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
Unstimulated salivary flow rate
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
Autoantibody titers
Time frame: Baseline and Weeks 4, 12, and 24
Immunoglobulin levels
Time frame: Baseline and Weeks 2, 4, 12, and 24
Peripheral blood lymphocyte subsets
Time frame: Baseline and Weeks 2, 4, 12, and 24
BCR/TCR repertoire
Time frame: Baseline and Weeks 4, 12, and 24
Adverse events
Time frame: From baseline through Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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 Blinatumomab and background treatment in people with Primary Sjögren's Syndrome (pSS), run by Beijing Tongren Hospital at 1 site in China.
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 18 inclusion and 11 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: opening soon, as of the sponsor's last update on 1 Oct 2026. 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 China. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bowen Wang, PhD (+86 15989006980, sysuwangbowen@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NEI corneal fluorescein staining score (time frame: Baseline and Week 24). The study lists 2 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 1 Oct 2026.