Clinical Efficacy of Telitacicept in Sjögren's Disease With Interstitial Lung Disease

NCT07843381 | Recruiting

• 1 other identifier: 2026-Telitacicept-SjD-ILD
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy Telitacicept in patients with primary Sjögren's Disease with interstitial lung disease

Conditions

Sjögren's Disease; Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Forced Vital Capacity Percent Predicted at Week 24

  FVC will be measured using standardized pulmonary function testing and expressed as the percentage of the predicted value. The outcome will be calculated as Week 24 FVC% predicted minus baseline FVC% predicted. The adjusted between-group difference will be estimated between the telitacicept and conventional-treatment cohorts.

  At baseline and at week 12,24

Secondary Outcomes (5)

• Change From Baseline in Diffusing Capacity for Carbon Monoxide Percent Predicted at Week 24

  Baseline, Week 12, and Week 24

• Change From Baseline in Total Lung Capacity at Week 24

  Baseline, Week 12, and Week 24

• Change From Baseline in HRCT Warrick Score at Week 24

  Baseline and Week 24

• Change From Baseline in Serum Krebs von den Lungen-6 at Week 24

  Baseline, Week 12, and Week 24

• Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index at Week 24

  Baseline, Week 12, and Week 24

Other Outcomes (1)

• Changes in Peripheral B-cell Subsets and Related Biomarkers

  Baseline, Week 12, and Week 24

Study Arms (2)

The telitacicept group

Patients in the treatment group will receive subcutaneous telitacicept 160 mg once weekly for 24 weeks, in addition to their background therapy (hydroxychloroquine and/or conventional immunosuppressive agents), and will be followed up regularly.

Drug: Telitacicept 160mg; Drug: Conventional treatment

The control group

Participants in the control group will receive background therapy (hydroxychloroquine and/or conventional immunosuppressive agents) alone for 24 weeks, and will be followed up regularly according to the same schedule.

Drug: Conventional treatment

Interventions

Telitacicept 160mg DRUG

The study duration was 24 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 24 weeks.

The telitacicept group

Conventional treatment DRUG

Conventional treatment with methylprednisolone (≤ 40 mg/day) and other immunosuppressive agents (including but not limited to cyclophosphamide, tacrolimus, sirolimus, cyclosporine, leflunomide, azathioprine, mycophenolate mofetil, hydroxychloroquine, tripterygium glycosides, methotrexate, and sulfasalazine). Treatment restrictions: The use of immunosuppressants was limited to a maximum of three agents throughout the 24-week period, and dose adjustments from baseline were restricted to within 30%.

The control group; The telitacicept group

Eligibility Criteria

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

Study Population

The study population will consist of 60 adult patients with primary Sjögren's disease and HRCT-confirmed interstitial lung disease, enrolled and allocated to treatment groups based on real-world clinical practice.

You may qualify if:

• Age 18 to 70 years, male or female.
• Diagnosis of primary Sjögren's Syndrome meeting the 2016 ACR/EULAR classification criteria.
• Confirmed diagnosis of Interstitial Lung Disease by High-Resolution Computed Tomography (HRCT).
• Stable doses of corticosteroids and immunosuppressants (e.g., mycophenolate mofetil) for at least 1 week prior to enrollment.
• Willing and able to provide written informed consent

You may not qualify if:

• Allergy: Known allergy or hypersensitivity to Telitacicept or any of its excipients.
• Concomitant Autoimmune Diseases: Diagnosis of other systemic autoimmune diseases besides Sjögren's Syndrome, such as Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Mixed Connective Tissue Disease (MCTD), or ANCA-associated vasculitis. (Note: Secondary Sjögren's Syndrome is not excluded on this basis alone, but the primary condition must be considered).
• Laboratory Abnormalities (at Screening):
• Hematology:
• Hemoglobin (Hb) \< 85 g/L. White Blood Cell count (WBC) \< 3.0 × 10\^9/L. Neutrophil count (NEUT) \< 1.5 × 10\^9/L. Platelet count (PLT) \< 80 × 10\^9/L.
• Liver Function:
• Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \> 2.5 × the upper limit of normal (ULN).
• Total bilirubin (TBIL) \> 1.5 × ULN.
• Kidney Function:
• Estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73m². Or serum creatinine (Cr) \> 1.5 × ULN.
• Significant Organ Diseases or Comorbidities:
• Cardiovascular: Myocardial infarction or unstable angina within the past 6 months; uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg); pulmonary arterial hypertension with evidence of right heart failure.
• Respiratory: Presence of other significant lung diseases (e.g., COPD, asthma, pulmonary embolism, active pulmonary tuberculosis).
• Gastrointestinal: Active peptic ulcer, gastrointestinal bleeding, or pancreatitis.
• Malignancy: History of any malignancy within the past 5 years (excluding successfully treated basal cell carcinoma of the skin or in-situ cervical carcinoma).

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Department of Rheumatology and Immunology, Peking University People's Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Sjogren's Syndrome; Lung Diseases, Interstitial

Interventions

telitacicept

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yuan Jia

  Peking University Institute of Rheuamotology and Immunology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Ning

CONTACT

+86 18292023082; ningjing9548@163.com

Yuan Jia

CONTACT

+86 15601066669; jiayuan1023@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 16, 2027
• Study Completion (Estimated): November 20, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)