A Phase 2 interventional study of Part A - Placebo for IBI355 and Part B -Telitacicept in Sjögren's Disease, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Innovent Biologics (Suzhou) Co. Ltd. (part of Innovent Biologics, Inc.) · Phase 2, Interventional, and Treatment
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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 the 10th largest by planned enrollment of the 47 interventional ones that give a count, is one of 13 that started in 2026, is one of 7 in phase 2, reaches primary completion later than 21 of the 31 other live ones, and was the 53rd 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+
Peking University People's Hospital · Sites in China
Ages 18–70
Shanghai Changzheng Hospital · 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 75 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 198 is above the median of 50 across 218 interventional 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:
This study is registered under Innovent Biologics (Suzhou) Co. Ltd., one of the names counted as Innovent Biologics, Inc.. Under that name alone:
Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 199 studies on the registry; 46 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Innovent Biologics, Inc. has 1 study 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 is a Phase II, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IBI355 in participants with moderate-to-severe Sj?gren's disease (SjD).
This study is a randomized, double-blind, placebo-controlled Phase II study in participants with moderate-to-severe Sjögren's disease. Eligible participants will be randomized to receive IBI355 or placebo during the double-blind treatment period.
The study will evaluate the efficacy of IBI355 in reducing systemic disease activity and improving patient-reported symptoms and disease-related functional outcomes. Safety and tolerability will be assessed throughout the study. Pharmacokinetic, immunogenicity, pharmacodynamic, and other relevant clinical assessments will also be performed as specified in the protocol.
The results of this study are intended to characterize the efficacy and safety profile of IBI355 in participants with Sjögren's disease and to support its further clinical development.
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：
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.
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
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.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
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.
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
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.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
IBI355，IV,corresponding dose regimen according to study cohort( Part A) .
Drug: Part A - Placebo for IBI355 · Drug: Part A - IBI355
Participants received telitacicept 160 mg SC QW from Week 0 to Week 24. Follow-up through Week 36
Drug: Part B -Telitacicept
Matching placebo of IBI355， IV ，corresponding dose regimen according to study design
Drug: Part A - Placebo for IBI355 · Drug: Part A - IBI355
Participants received matching placebo SC QW from Week 0 to Week 24. Follow-up through Week 36.
Drug: PartB -Placebo for Telitacicept
Matching placebo of IBI355， IV ，corresponding dose regimen according to study design
Telitacicept 160 mg SC QW × 24 doses (Weeks 0-24).
Matching placebo of Talitacicept ，SC QW × 24 doses.
IBI355,IV,corresponding dose regimen according to study design
Change from Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 24
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is a physician-assessed index used to evaluate systemic disease activity in Sjögren's disease. The total score ranges from 0 to 123, with higher scores indicating greater systemic disease activity. A decrease from baseline indicates improvement.
Time frame: Baseline and Week 24
Change from Baseline in ESSDAI Score at Weeks 12 and 48
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is a physician-assessed index used to evaluate systemic disease activity in Sjögren's disease. The total score ranges from 0 to 123, with higher scores indicating greater systemic disease activity. A decrease from baseline indicates improvement.
Time frame: Baseline to Weeks 12 and 48
Change from Baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Weeks 12, 24, and 48
The EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a patient-reported measure assessing dryness, fatigue, and pain. Each domain is rated on a 0-to-10 numerical rating scale, and the total ESSPRI score is calculated as the mean of the three domain scores, ranging from 0 to 10. Higher scores indicate greater symptom severity. A decrease from baseline indicates improvement.
Time frame: Baseline to Weeks 12, 24, and 48
Change from Baseline in Stimulated Salivary Flow (sSF) Rate at Weeks 12, 24, and 48
Stimulated salivary flow rate will be measured according to the protocol-specified procedure. An increase from baseline indicates an improvement in stimulated salivary gland function.
Time frame: Baseline to Weeks 12, 24, and 48
Change from Baseline in Schirmer Test at Week 48
The Schirmer test is used to assess tear production and is reported as the length of wetting of the test strip over 5 minutes, measured in millimeters (mm/5 min). Higher values indicate greater tear production.
Time frame: Baseline to Week 48
Change from Baseline in Sj?gren's Tool for Assessing Response (STAR) Score at Week 48
The Sj?gren's Tool for Assessing Response (STAR) is a composite assessment of treatment response in Sj?gren's disease incorporating systemic disease activity, patient-reported symptoms, and biological and glandular domains. Higher scores indicate a greater treatment response.
Time frame: Baseline to Week 48
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Weeks 12, 24, and 48
The FACIT-Fatigue scale is a 13-item patient-reported measure of fatigue. The total score ranges from 0 to 52, with higher scores indicating less fatigue and better functioning. An increase from baseline indicates improvement.
Time frame: Baseline to Weeks 12, 24, and 48
Change from Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Score at Weeks 12, 24, and 48
The EQ-5D-5L is a standardized measure of health status assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity. Responses are converted to an EQ-5D-5L index score using the prespecified value set, with higher index scores indicating better health status.
Time frame: Baseline to Weeks 12, 24, and 48
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
The number and percentage of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) will be assessed throughout the study.
Time frame: From the first dose of study intervention through Week 48
Start is estimated for Oct 2026; primary completion for Nov 2027, 12 months later.
Of 26 phase 2 interventional studies under Sjogren's Syndrome, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 43. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Innovent Biologics (Suzhou) Co. Ltd. →