An observational study in Sjögren's Disease and Interstitial Lung Disease, sponsored by Peking University People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Peking University People's Hospital · Observational
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Among 55 studies in Sjogren's Syndrome with a site in China — 28 open to participants now, 32 under way, 5 of them phase 3. Sjogren's Syndrome · China.
Among the 55 studies in Sjogren's Syndrome with a site in China, this one is one of 13 that started in 2026, is one of 8 observational ones, reaches primary completion later than 20 of the 31 other live ones, and was the 54th registered.
330 studies on the registry are indexed under Sjogren's Syndrome; 99 are open to participants now.
Browse Sjogren's Syndrome studies →28 of the 55 studies in Sjogren's Syndrome with a site in China are open now. Recruiting first, the newest first:
Antengene Biologics Limited · Sites in China
Ages 18+
Novartis Pharmaceuticals · Sites in China, United States, Australia and 6 more countries
Ages 18–100
Novartis Pharmaceuticals · Sites in China, United States, Australia and 17 more countries
Ages 18+
Shanghai Changzheng Hospital · Sites in China
Ages 18–65
Therorna · Sites in China
Ages 18–65
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 67 Sjogren's Syndrome studies recruiting now, 26 (39%) set no upper age limit and 25 (37%) stop at 75 or younger; 9 take children under 18; 11 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
55 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 23 · Phase 2 15 · Phase 3 7 · Phase 4 3
First in 2009; this study’s year is marked. 13 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 139 across 100 observational studies indexed under Sjogren's Syndrome.
Median enrollment 30 across the 47 interventional studies, 75 across the 8 observational. Of the 13 that completed or were terminated, 2 (15%) have results posted.
This tab as a report to print or save as PDF → With an account.
22 of 55 have an industry lead sponsor. The 10 most frequent:
Peking University People's Hospital is the lead sponsor of 610 studies on the registry; 248 are open to participants now.
Peking University People's Hospital has 4 studies filed under Sjogren's Syndrome — fewer than ten, so there is no comparison to draw.
11 of the studies in Sjogren's Syndrome with a site in China that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05946941Phase 3Bristol-Myers SquibbA Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome | 2026-11-18 |
| NCT06741969Phase 3Janssen Research & Development, LLCNipocalimab in Moderate to Severe Sjogren's Disease | 2027-02-04 |
| NCT07236762China Immunotech (Beijing) Biotechnology Co., Ltd.An Exploratory Clinical Study of YTS109 Cell for R/R Autoimmune Diseases | 2026-11-24 |
| NCT06548607Nanjing Bioheng Biotech Co., Ltd.Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases | 2026-12-31 |
| NCT07439029Children's Hospital of Fudan UniversityYTS109 in Pediatric Relapsed/Refractory Autoimmune Diseases | 2027-03 |
Add all 11 to your calendar (.ics) → With an account.
Among the 55 studies in Sjogren's Syndrome with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study aims to evaluate the efficacy Telitacicept in patients with primary Sjögren's Disease with interstitial lung disease
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Laboratory Abnormalities (at Screening):
Hematology:
(Hb) \< 85 g/L. White Blood Cell count (WBC) \< 3.0 × 10\^9/L. (NEUT) \< 1.5 × 10\^9/L. count (PLT) \< 80 × 10\^9/L.
Liver Function:
(ALT) or Aspartate aminotransferase (AST) > 2.5 × the (ULN).
Total (TBIL) > 1.5 × ULN.
Kidney Function:
Estimated (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., , asthma, pulmonary embolism, active pulmonary tuberculosis).
Gastrointestinal: Active peptic ulcer, gastrointestinal bleeding, or pancreatitis.
: 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 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 antibody. Positive surface antigen (HBsAg), or positive Hepatitis B core antibody (HBcAb) with detectable HBV DNA.
Positive antibody with detectable HCV RNA.
Special Populations:
Women who are pregnant or breastfeeding. Women of who are unwilling or unable to use highly effective 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.
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).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
The study duration was 24 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 24 weeks.
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%.
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.
Time frame: At baseline and at week 12,24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 12, and Week 24
Changes in Peripheral B-cell Subsets and Related Biomarkers
Changes from baseline in total B cells, B-cell subsets, immunoglobulins, and soluble CD25 will be evaluated. Associations between immunologic changes and changes in FVC% predicted, DLCO% predicted, Warrick score, and KL-6 will be explored.
Time frame: Baseline, Week 12, and Week 24
Plan to share: Yes
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Sep 2027, 16 months after the start.
Of 40 observational studies under Sjogren's Syndrome, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 21. This study's planned 16 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Peking University People's Hospital →