Exploratory Study on the Efficacy and Safety of Low-Dose Blinatumomab in the Treatment of Moderate to Severe Primary Sjögren's Syndrome

NCT07852234 | Not Yet Recruiting Phase 2

• 1 other identifier: TREC2026-KY238
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Primary Sjögren's Syndrome (pSS)

Keywords

Primary Sjögren's Syndrome; Blinatumomab for Injection; Dry eye disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and Week 24

Secondary Outcomes (17)

• NEI score at follow-up visits

  Baseline and Weeks 2, 4, 8, 12, 16, and 20

• OSDI score

  Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24

• FBUT

  Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24

• Schirmer I test

  Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24

• NIBUT

  Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24

Study Arms (2)

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.

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.

Drug: Blinatumomab; Drug: background treatment

Interventions

Blinatumomab DRUG

Participants 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.

Experimental group

background treatment DRUG

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.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Bowen Wang, PhD

CONTACT

+86 15989006980; sysuwangbowen@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Beijing Tongren Hospital, Chief Physician of Ophthalmology Department

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start: September 25, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)