Sjögren's DiseaseNCT07843381
Clinical Efficacy of Telitacicept in Sjögren's Disease With Interstitial Lung Disease
An observational study of Sjögren's Disease and Interstitial Lung Disease, run by Peking University People's Hospital at 1 site in China.
Trial summary
This study aims to evaluate the efficacy Telitacicept in patients with primary Sjögren's Disease with interstitial lung disease Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sjögren's Disease, Interstitial Lung Disease
- What is being tested?
- Telitacicept 160mg and Conventional treatment
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 20 Nov 2027
- Phase
- Observational
- 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
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.
Who may be able to join
- 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
Who cannot join
- 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:
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- 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).
- Psychiatric: Severe mental illness (e.g., severe depression, schizophrenia) or cognitive impairment that may interfere with compliance.
- Prior/Concomitant Medications:
- Use of rituximab, belimumab, TNF inhibitors (e.g., etanercept, adalimumab), or ther biologic agents (e.g., IL-6, IL-17, IL-23 inhibitors) within 3 months prior to screening.
- Participation in another interventional clinical trial (receiving investigational drug or device) within 4 weeks prior to screening.
- Active Infection:
- Presence of an active infection requiring systemic anti-infective treatment at screening.
- Active tuberculosis (positive T-SPOT.TB or TST with chest X-ray/CT findings suggestive of active disease).
- Positive HIV antibody. Positive Hepatitis B surface antigen (HBsAg), or positive Hepatitis B core antibody (HBcAb) with detectable HBV DNA.
- Positive Hepatitis C antibody with detectable HCV RNA.
- Special Populations:
- Women who are pregnant or breastfeeding. Women of childbearing potential who are unwilling or unable to use highly effective contraceptive methods from screening until at least 3 months after the last dose of study drug.
- Patients planning to undergo major surgery during the study period.
- Other Situations:
- Inability to cooperate with pulmonary function tests (e.g., due to severe cognitive impairment or dyspnea).
- Any condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study (e.g., poor compliance, inability to understand study procedures).
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, 1 recruiting
- Recruiting
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing
Jing Ning, +86 18292023082, ningjing9548@163.com
Jia Yuan, +86 15601066669, jiayuan1023@bjmu.edu.cn
About this study
Official title: A Prospective Cohort Study of Telitacicept Versus Conventional Immunosuppressive Agents in Primary Sjögren's Disease With Interstitial Lung Disease
This study aims to evaluate the efficacy Telitacicept in patients with primary Sjögren's Disease with interstitial lung disease
Read the detailed description
This is a prospective, open-label, single-center cohort study to evaluate the real-world effectiveness of Telitacicept compared with conventional immunosuppressive therapy in patients with primary Sjögren's disease associated interstitial lung disease. A total of 60 patients with confirmed interstitial lung disease by high-resolution computed tomography will be enrolled and allocated into two cohorts based on the treatment regimen selected by their treating physician according to clinical indications and patient preference: one cohort receiving Telitacicept 160 mg subcutaneously once weekly and the other receiving conventional immunosuppressive agents.
Treatment effectiveness will be evaluated over 24 weeks. The primary outcome is the change from baseline in forced vital capacity percent predicted (FVC% predicted) at Week 24. Secondary assessments include DLCO% predicted, total lung capacity, HRCT changes quantified using the Warrick score, KL-6, ESSDAI. Changes in B-cell subsets and related biomarkers will be explored for associations with pulmonary outcomes.
- Conditions
- Sjögren's Disease, Interstitial Lung Disease
- Being tested
- Telitacicept 160mg, Conventional treatment
- Medical subject headings
- Sjogren's Syndrome, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telitacicept 160mgDrug
The study duration was 24 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 24 weeks.
Conventional treatmentDrug
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%.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and at week 12,24
Secondary outcomes (5)
Change From Baseline in Diffusing Capacity for Carbon Monoxide Percent Predicted at Week 24
The outcome will be calculated as Week 24 DLCO% predicted minus baseline DLCO% predicted.
Measured: Baseline, Week 12, and Week 24
Change From Baseline in Total Lung Capacity at Week 24
Total lung capacity will be measured by standardized pulmonary function testing. Both the observed value and percent predicted, where available, will be recorded.
Measured: Baseline, Week 12, and Week 24
Change From Baseline in HRCT Warrick Score at Week 24
HRCT abnormalities will be assessed using the Warrick scoring system. The severity score ranges from 0 to 15 and is based on five abnormalities: ground-glass opacity (1 point), irregular pleural margins (2 points), septal or subpleural lines (3 points), honeycombing (4 points), and subpleural cysts (5 points). For each abnormality, extent is scored according to the number of bronchopulmonary segments involved: 1-3 segments (1 point), 4-9 segments (2 points), and more than 9 segments (3 points), giving a total extent score of 0-15. The Warrick total score is the sum of severity and extent scores and ranges from 0 to 30, with higher scores indicating greater ILD involvement.
Measured: Baseline and Week 24
Change From Baseline in Serum Krebs von den Lungen-6 at Week 24
Serum Krebs von den Lungen-6 (KL-6) concentration will be measured as a biomarker associated with interstitial lung disease activity and severity.
Measured: Baseline, Week 12, and Week 24
Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index at Week 24
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) will be assessed at each specified visit. The outcome is Week 24 ESSDAI minus baseline ESSDAI.
Measured: Baseline, Week 12, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 May 2026
- Primary completion16 Sep 2027 (estimated)
- Study completion20 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögren's DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing He, Peking University People's Hospital
- Investigators
- Yuan Jia, Principal investigator, Peking University Institute of Rheuamotology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843381
- Sponsor's protocol ID
- 2026-Telitacicept-SjD-ILD
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Telitacicept Versus Conventional Immunosuppressive Agents in Primary Sjögren's Disease With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07843381
- Acronym / sponsor ID
- 2026-Telitacicept-SjD-ILD
- Conditions
- Sjögren's Disease, Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 16 Sep 2027 (estimated)
- Study completion
- 20 Nov 2027 (estimated)
- First posted
- 28 Sep 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.
This study aims to evaluate the efficacy Telitacicept in patients with primary Sjögren's Disease with interstitial lung disease
Detailed description
This is a prospective, open-label, single-center cohort study to evaluate the real-world effectiveness of Telitacicept compared with conventional immunosuppressive therapy in patients with primary Sjögren's disease associated interstitial lung disease. A total of 60 patients with confirmed interstitial lung disease by high-resolution computed tomography will be enrolled and allocated into two cohorts based on the treatment regimen selected by their treating physician according to clinical indications and patient preference: one cohort receiving Telitacicept 160 mg subcutaneously once weekly and the other receiving conventional immunosuppressive agents.
Treatment effectiveness will be evaluated over 24 weeks. The primary outcome is the change from baseline in forced vital capacity percent predicted (FVC% predicted) at Week 24. Secondary assessments include DLCO% predicted, total lung capacity, HRCT changes quantified using the Warrick score, KL-6, ESSDAI. Changes in B-cell subsets and related biomarkers will be explored for associations with pulmonary outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The telitacicept group | – | Drug: Telitacicept 160mg, Drug: Conventional treatmentPatients 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. |
| The control group | – | Drug: Conventional treatmentParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (30 listed)
- 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):
- 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.
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 2.5 × the upper limit of normal (ULN).
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 |
|---|---|---|
| Telitacicept 160mgThe study duration was 24 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 24 weeks. | Drug | The telitacicept group |
| Conventional treatmentConventional 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%. | Drug | The control group, The telitacicept group |
Primary outcome
Change From Baseline in Forced Vital Capacity Percent Predicted at Week 24
Time frame: At baseline and at week 12,24
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.
5 secondary outcomes
Change From Baseline in Diffusing Capacity for Carbon Monoxide Percent Predicted at Week 24
Time frame: Baseline, Week 12, and Week 24
Change From Baseline in Total Lung Capacity at Week 24
Time frame: Baseline, Week 12, and Week 24
Change From Baseline in HRCT Warrick Score at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Serum Krebs von den Lungen-6 at Week 24
Time frame: Baseline, Week 12, and Week 24
Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index at Week 24
Time frame: Baseline, Week 12, and 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 28 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
Yuan Jia principal investigator
Peking University Institute of Rheuamotology and Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjögren's Disease and Interstitial Lung Disease, run by Peking University People's 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 5 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 28 Sep 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.
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 Jing Ning (+86 18292023082, ningjing9548@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Forced Vital Capacity Percent Predicted at Week 24 (time frame: At baseline and at week 12,24). 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 28 Sep 2026.