Primary Sjögren's Syndrome (pSS)Phase 1NCT07818694
JH013 Injection in Patients With Primary Sjögren's Syndrome
A Phase 1 study testing JH013 injection in people with Primary Sjögren's Syndrome (pSS), run by Biotech Pharmaceutical Co., Ltd..
Trial summary
This is a multicenter, open-label, single-arm Phase I study consisting of two parts: Part A, a single-dose dose-escalation phase, and Part B, a multiple-dose dose-escalation phase. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Sjögren's Syndrome (pSS)
- What is being tested?
- JH013 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 28 Dec 2028
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary Sjögren's syndrome (pSS) who meet the 2016 ACR/EULAR classification criteria for primary Sjögren's syndrome; 18 to 65 years of age (inclusive) for Part A and 18 to 75 years of age (inclusive) for Part B;
- EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥6 during the Screening Period;
- EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score ≥5 during the Screening Period;
- Elevated serological markers during the Screening Period, defined as an antinuclear antibody (ANA) titer ≥1:160 and positive rheumatoid factor (RF), or positive anti-SSA antibody (with or without anti-SSB antibody);
- Stimulated whole salivary flow rate ≥0.05 mL/min or unstimulated whole salivary flow rate ≥0.01 mL/min during the Screening Period;
- Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test within 72 hours prior to dosing. Postmenopausal women (defined as amenorrhea for at least 12 months) and women with a known history of hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation are considered not to be of childbearing potential and are not required to undergo a pregnancy test;
- Participants must understand and comply with the study procedures, voluntarily participate in the study, and provide written informed consent.
Who cannot join
- Secondary Sjögren's syndrome, defined as Sjögren's syndrome overlapping with another autoimmune disease or systemic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, or idiopathic inflammatory myopathy);
- Use of another investigational medicinal product within 5 half-lives or 30 days prior to Screening, whichever is longer, or within a period during which the expected pharmacodynamic effect has not returned to baseline, whichever is longer; or for a longer period if required for the investigational medicinal product;
- Use of B-cell-depleting therapies within 24 weeks prior to Screening (e.g., VAY736, rituximab, other anti-CD20 monoclonal antibodies, anti-CD22 monoclonal antibodies, or anti-CD52 monoclonal antibodies), or B-cell counts have not recovered to the lower limit of normal or baseline following prior B-cell-depleting therapy, whichever is lower;
- Receipt of any of the following prior treatments before Screening:
- Within 24 weeks: iscalimab (anti-CD40 monoclonal antibody), belimumab (anti-BAFF monoclonal antibody), telitacicept, abatacept (CTLA4-Fc-Ig), anti-tumor necrosis factor-alpha (TNF-α) biologics, intravenous or subcutaneous immunoglobulin (IVIG/SCIG), or plasma exchange;
- Within 12 weeks: intravenous or oral cyclophosphamide, mycophenolate mofetil (MMF), intravenous or oral cyclosporine A, or any other immunomodulatory/immunosuppressive medication (e.g., JAK inhibitors or other kinase inhibitors);
Show all 33Show fewer
- Prednisone dose >10 mg/day, or any adjustment to the prednisone dose within 2 weeks prior to Screening;
- Currently receiving azathioprine, or use of azathioprine within 3 months prior to Screening. Patients who have been receiving a stable dose of hydroxychloroquine or methotrexate for ≥3 months prior to Screening and who will maintain the same dose throughout the study may be eligible;
- Use of traditional Chinese medicines (TCM) or proprietary Chinese medicines for the treatment of primary Sjögren's syndrome within 4 weeks prior to Screening, including Tripterygium wilfordii polyglycosides and total glucosides of paeony;
- Use of sialagogues within 7 days prior to Screening, such as anethole trithione or pilocarpine;
- Severe systemic involvement of Sjögren's syndrome, as assessed by the Investigator, including but not limited to:
- Severe vasculitis involving the kidneys, gastrointestinal system, heart, lungs, or central nervous system (excluding cutaneous vasculitis);
- Active central or peripheral nervous system involvement requiring high-dose glucocorticoid therapy;
- Severe renal involvement, such as estimated glomerular filtration rate (eGFR) <60 mL/min, serum creatinine >2 mg/dL, or urinary protein >3 g/day;
- Severe pulmonary involvement, such as dyspnea at rest, or pulmonary function test results showing forced vital capacity (FVC) <60% or diffusing capacity of the lung for carbon monoxide (DLCO) <40%;
- Myositis requiring high-dose glucocorticoid therapy;
- Lymphoma;
- Abnormal laboratory parameters:
- Hematology: hemoglobin <8.0 g/dL, white blood cell (WBC) count <2.0 × 10⁹/L, platelet count <75 × 10⁹/L, or absolute neutrophil count (ANC) <1.0 × 10⁹/L;
- Clinical chemistry: total bilirubin >1.5 × ULN, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × ULN;
- Active viral, bacterial, or other infection requiring systemic treatment, or a clinically significant history of recurrent infections;
- Known hypersensitivity to any component of JH013 or its excipients, including histidine, dilute hydrochloric acid, arginine hydrochloride, or sucrose;
- History of organ, hematopoietic stem cell, or bone marrow transplantation;
- Requirement for regular use of medications known to cause dry mouth or dry eyes, including but not limited to beta-blockers, antihistamines, pseudoephedrine, selective antidepressants, anticholinergic agents, sedatives, antipsychotics, antiparkinsonian medications, and diuretics;
- Use of topical ophthalmic prescription medications, excluding artificial tears, gels, and lubricants, with no stable dose for at least 90 days prior to Screening, or any anticipated change in the treatment regimen during the study;
- Receipt of a live or live-attenuated vaccine within 30 days prior to Screening;
- History of malignancy in any organ system within the past 5 years, whether treated or untreated and regardless of evidence of local recurrence or metastasis, except for locally treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, or Sjögren's syndrome-associated lymphoma;
- History of sarcoidosis;
- Any condition considered by the Investigator to be unsuitable for participation in the study, including surgery, medical conditions (e.g., inadequately controlled hypertension, heart failure, or diabetes), psychiatric disorders, or other conditions;
- Positive test results for human immunodeficiency virus (HIV) antibodies; positive hepatitis B virus (HBV) surface antigen (HBsAg), or positive HBV core antibody (anti-HBc) with positive HBV DNA; positive hepatitis C virus (HCV) antibody; or positive syphilis serology;
- History of tuberculosis (TB) or a positive interferon-gamma release assay (IGRA) at Screening. An IGRA result obtained within 3 months prior to Screening is acceptable;
- Known history of poor medication adherence, or inability or unwillingness to complete the study questionnaires;
- Pregnancy or breastfeeding; planned pregnancy; or women of childbearing potential or sexually active men who are unwilling to use reliable contraception during the study and for 3 months after the last dose of study drug, or who intend to donate sperm during the same period.
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of JH013 Injection in Patients With Primary Sjögren's Syndrome
This is a multicenter, open-label, single-arm Phase I study consisting of two parts: Part A, a single-dose dose-escalation phase, and Part B, a multiple-dose dose-escalation phase. The study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and clinical efficacy of JH013 Injection in patients with primary Sjögren's syndrome (pSS).
Part A: Six dose levels are planned: 15, 45, 90, 150, 225, and 315 mg. A 3+3 dose-escalation design will be used, with 3 participants initially enrolled at each dose level to receive a single subcutaneous injection into the abdominal wall. If no dose-limiting toxicity (DLT) occurs, escalation may proceed. If 1 of 3 participants experiences a DLT, 3 additional participants may be enrolled at the same dose. If ≥2 of 6 participants experience a DLT, escalation will be stopped or a lower dose may be explored. DLTs are defined as Grade ≥3 cytokine release syndrome (CRS), or Grade ≥3 infection, hypersensitivity reaction, or other study-drug-related adverse event that does not recover within 1 week of treatment, according to Common Terminology Criteria for Adverse Events（CTCAE） Version 6.0. Additional participants may be enrolled if PK/PD results suggest a potentially therapeutic dose or if additional data are considered necessary. One participant will initially be enrolled at each dose level and observed for 72 hours before further participants are enrolled. Up to 36 participants are planned. Dose escalation will proceed only after acceptable safety and tolerability for at least 21 days after the preceding dose are confirmed by the investigator and sponsor.
Read more
Part B: Three ascending dose levels will be selected based on the Phase I healthy participant study and Part A results. A 3+3 design will be used, with 3 participants initially enrolled at each dose level. JH013 will be administered subcutaneously into the abdominal wall once every 4 weeks for a total of 6 doses. The same DLT definitions and escalation rules as Part A will apply. Up to 18 participants are planned. Escalation will proceed only after acceptable safety and tolerability of the preceding dose are confirmed within 2 weeks after the second dose.
If predefined dose-escalation termination criteria are met, an intermediate or lower dose may be explored to further determine the maximum tolerated dose. If the highest planned dose is reached without meeting the termination criteria, a higher dose may be considered. If any study-drug-related serious adverse event (SAE) occurs, study activities will be suspended and the investigator and sponsor will jointly assess the event and its impact on further study conduct.
All participants will receive recommended premedication with intravenous methylprednisolone 250 mg 1-2 hours before the first dose, or an equivalent glucocorticoid. The regimen may be adjusted based on the participant's clinical condition. Vital signs and laboratory parameters, including Interleukin-6（IL-6）, Interleukin-10（IL-10）, and Tumor Necrosis Factor-alpha（TNF-α,） will be monitored for early identification of CRS. CRS will be assessed and managed according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS grading criteria, with treatment ranging from symptomatic management and close monitoring for Grade 1 to intensive care and life-supportive treatment for Grade 4, with corticosteroids and tocilizumab used as clinically indicated.
Participants will undergo screening within 21 days before the first dose. In Part A, participants will be admitted on Day -1, receive baseline PK/PD sampling before dosing, and remain at the study center until Day 3 for PK/PD sampling and safety assessment. Follow-up assessments of PK, PD, immunogenicity, efficacy, and safety will continue through Day 169. Participants with inadequate recovery of Cluster of Differentiation 19 positive （CD19+） B-cell counts after Day 85 may continue follow-up every 3 months for up to 6 months. In Part B, participants will receive 6 doses at 4-week intervals. They will remain at the study center through Day 3 after the first and final doses for PK/PD sampling and safety assessment; other dosing visits may be conducted on an outpatient basis or with 1-2 days of inpatient observation based on safety findings. After treatment completion, participants will undergo follow-up for 24 weeks to monitor CD19+ B-cell recovery, safety, PK/PD, immunogenicity, and clinical efficacy.
- Conditions
- Primary Sjögren's Syndrome (pSS)
- Being tested
- JH013 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JH013 injectionBiological
Anti-B-cell Activating Factor Receptor（Anti-BAFFR） Monoclonal Antibody
| Study group | Role | What they receive |
|---|---|---|
| JH013 injection, 15mg，single dose | Experimental | Not described Receives: Biological: JH013 injection |
| JH013 injection, 45mg，single dose | Experimental | Not described Receives: Biological: JH013 injection |
| JH013 injection, 90mg，single dose | Experimental | Not described Receives: Biological: JH013 injection |
| JH013 injection, 150mg，single dose | Experimental | Not described Receives: Biological: JH013 injection |
| JH013 injection, 225mg，single dose | Experimental | Not described Receives: Biological: JH013 injection |
| JH013 injection, 315mg，single dose | Experimental | Not described Receives: Biological: JH013 injection |
| JH013 injection, dose 1，multiple doses | Experimental | Not described Receives: Biological: JH013 injection |
| JH013 injection, dose 2，multiple doses | Experimental | Not described Receives: Biological: JH013 injection |
| JH013 injection, dose 3，multiple doses | Experimental | Not described Receives: Biological: JH013 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events（AEs）
CACAE 6.0
Measured: From day 1 to day 169
Number of participants with adverse events（AEs）
Measured: From Week 1 to Week 49
Secondary outcomes (37)
Pharmacokinetic parameters of JH013：Elimination half-life（t1/2）
Measured: From day 1 to day 169
Pharmacokinetic parameters of JH013：Maximum observed plasma concentration（Cmax）
Measured: From day 1 to day 169
Pharmacokinetic parameters of JH013：Time to maximum observed plasma concentration（Tmax)
Measured: From day 1 to day 169
Pharmacokinetic parameters of JH013：Area under the plasma concentration-time curve from time zero to the last measurable concentration（AUC 0-t）
Measured: From day 1 to day 169
Pharmacokinetic parameters of JH013：Area under the plasma concentration-time curve from time zero extrapolated to infinity（AUC0-∞）
Measured: From day 1 to day 169
Pharmacokinetic parameters of JH013：Volume of distribution during the terminal phase（Vz）
Measured: From day 1 to day 169
Pharmacokinetic parameters of JH013：Total body clearance（CL）
Measured: From day 1 to day 169
Immunogenicity of JH013：Anti-drug antibody（ADA）
Measured: From day 1 to day 169
Pharmacokinetic parameters of JH013：Time to maximum observed plasma concentration at steady state（Tss_max）
Measured: From week 1 to week 32
Pharmacokinetic parameters of JH013：Maximum observed plasma concentration at steady state（Css_max）
Measured: From week 1 to week 32
Pharmacokinetic parameters of JH013：Minimum observed plasma concentration at steady state（Css_min）
Measured: From week 1 to week 32
Pharmacokinetic parameters of JH013：Area under the plasma concentration-time curve from time zero to the last measurable concentration at steady state（AUCss 0-t）
Measured: From week 1 to week 32
Pharmacokinetic parameters of JH013：Area under the plasma concentration-time curve from time zero extrapolated to infinity at steady state（AUCss 0-∞）
Measured: From week 1 to week 32
Pharmacokinetic parameters of JH013：Accumulation ratio based on AUC（RAUC）
Measured: From week 1 to week 32
Pharmacokinetic parameters of JH013：Accumulation ratio based on Cmax（RCmax）
Measured: From week 1 to week 32
Pharmacokinetic parameters of JH013：Apparent clearance at steady state（CL/Fss）
Measured: From week 1 to week 32
Pharmacokinetic parameters of JH013：Apparent volume of distribution during the terminal phase at steady state（Vz/Fss）
Measured: From week 1 to week 32
Pharmacokinetic parameters of JH013：Terminal elimination rate constant at steady state（Kelss）
Measured: From week 1 to week 32
Pharmacokinetic parameters of JH013：Terminal half-life at steady state（t½ss）
Measured: From week 1 to week 32
Pharmacokinetic parameters of JH013：Mean residence time（MRT）
Measured: From week 1 to week 32
Pharmacokinetic parameters of JH013：Renal clearance（CLR）
Measured: From week 1 to week 32
CD45+CD19+ B-cell count and percentage
Measured: From week 1 to week 32
B-cell activating factor (BAFF) concentration
Measured: From week 1 to week 32
JH013 antibody receptor occupancy (RO)
Measured: From week 1 to week 32
CD45+CD3+ T-cell count and percentage
Measured: From week 1 to week 32
Cytokines: IL-2, IL-4, IL-6, IL-10, TNF-α, and IFN-γ concentration
Measured: From week 1 to week 32
Immunoglobulins (IgG, IgM, and IgA) concentration
Measured: From week 1 to week 32
Complement C3 and complement C4 concentration
Measured: From week 1 to week 32
Rheumatoid factor (RF) concentration
Measured: From week 1 to week 32
Change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is a physician-assessed measure of systemic disease activity in primary Sjögren's syndrome. The total score ranges from 0 to 123, with higher scores indicating greater disease activity. Change from baseline will be calculated as the score at the specified assessment time point minus the baseline score.
Measured: Week 1 to Week 48
Change from baseline in the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score
The EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) assesses patient-reported symptom severity, including dryness, fatigue, and pain. The total score ranges from 0 to 10, with higher scores indicating greater symptom severity and worse outcome. Change from baseline will be calculated as the score at the specified assessment time point minus the baseline score.
Measured: From Week 1 to Week 48
Change from baseline in the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) score
The 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) score is a standardized measure of physical health-related quality of life. The score is generally standardized to a 0 to 100 scale, with higher scores indicating better health status. Change from baseline will be calculated as the score at the specified assessment time point minus the baseline score.
Measured: From Week 1 to Week 48
Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale assesses fatigue and its impact on daily functioning. The fatigue subscale score ranges from 0 to 52, with higher scores indicating less fatigue and better outcome. Change from baseline will be calculated as the score at the specified assessment time point minus the baseline score.
Measured: From Week 1 to Week 48
Change from baseline in Physician's Global Assessment (PhGA) score
Physician's Global Assessment (PhGA) is a physician-rated assessment of the patient's overall disease activity. The score ranges from 0 to 10, with higher scores indicating greater disease activity and worse outcome. Change from baseline will be calculated as the score at the specified assessment time point minus the baseline score.
Measured: From Week 1 to Week 48
Change from baseline in unstimulated whole salivary flow rate
Unstimulated whole salivary flow rate will be measured as the volume of saliva collected over a specified collection period and expressed in mL/min. Change from baseline will be calculated as the value at the specified assessment time point minus the baseline value.
Measured: From Week 1 to Week 48
Change from baseline in Schirmer I test score
The Schirmer I test measures tear production using a standardized filter paper strip placed under the lower eyelid for a specified period. The result is expressed as the length of wetting in millimeters (mm). Higher values indicate greater tear production. Change from baseline will be calculated as the value at the specified assessment time point minus the baseline value.
Measured: From Week 1 to Week 48
Change from baseline in Patient's Global Assessment (PaGA) score
Patient's Global Assessment (PaGA) is a patient-reported assessment of overall disease activity or disease severity. The score ranges from 0 to 10, with higher scores indicating greater disease activity/severity and worse outcome. Change from baseline will be calculated as the score at the specified assessment time point minus the baseline score.
Measured: From Week 1 to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion28 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren's Syndrome (pSS)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818694
- Sponsor's protocol ID
- BPL-JH013-pSS-1002
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of JH013 Injection in Patients With Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT07818694
- Acronym / sponsor ID
- BPL-JH013-pSS-1002
- Conditions
- Primary Sjögren's Syndrome (pSS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 28 Dec 2028 (estimated)
- First posted
- 14 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 is a multicenter, open-label, single-arm Phase I study consisting of two parts: Part A, a single-dose dose-escalation phase, and Part B, a multiple-dose dose-escalation phase. The study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and clinical efficacy of JH013 Injection in patients with primary Sjögren's syndrome (pSS).
Part A: Six dose levels are planned: 15, 45, 90, 150, 225, and 315 mg. A 3+3 dose-escalation design will be used, with 3 participants initially enrolled at each dose level to receive a single subcutaneous injection into the abdominal wall. If no dose-limiting toxicity (DLT) occurs, escalation may proceed. If 1 of 3 participants experiences a DLT, 3 additional participants may be enrolled at the same dose. If ≥2 of 6 participants experience a DLT, escalation will be stopped or a lower dose may be explored. DLTs are defined as Grade ≥3 cytokine release syndrome (CRS), or Grade ≥3 infection, hypersensitivity reaction, or other study-drug-related adverse event that does not recover within 1 week of treatment, according to Common Terminology Criteria for Adverse Events（CTCAE） Version 6.0. Additional participants may be enrolled if PK/PD results suggest a potentially therapeutic dose or if additional data are considered necessary. One participant will initially be enrolled at each dose level and observed for 72 hours before further participants are enrolled. Up to 36 participants are planned. Dose escalation will proceed only after acceptable safety and tolerability for at least 21 days after the preceding dose are confirmed by the investigator and sponsor.
Part B: Three ascending dose levels will be selected based on the Phase I healthy participant study and Part A results. A 3+3 design will be used, with 3 participants initially enrolled at each dose level. JH013 will be administered subcutaneously into the abdominal wall once every 4 weeks for a total of 6 doses. The same DLT definitions and escalation rules as Part A will apply. Up to 18 participants are planned. Escalation will proceed only after acceptable safety and tolerability of the preceding dose are confirmed within 2 weeks after the second dose.
If predefined dose-escalation termination criteria are met, an intermediate or lower dose may be explored to further determine the maximum tolerated dose. If the highest planned dose is reached without meeting the termination criteria, a higher dose may be considered. If any study-drug-related serious adverse event (SAE) occurs, study activities will be suspended and the investigator and sponsor will jointly assess the event and its impact on further study conduct.
All participants will receive recommended premedication with intravenous methylprednisolone 250 mg 1-2 hours before the first dose, or an equivalent glucocorticoid. The regimen may be adjusted based on the participant's clinical condition. Vital signs and laboratory parameters, including Interleukin-6（IL-6）, Interleukin-10（IL-10）, and Tumor Necrosis Factor-alpha（TNF-α,） will be monitored for early identification of CRS. CRS will be assessed and managed according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS grading criteria, with treatment ranging from symptomatic management and close monitoring for Grade 1 to intensive care and life-supportive treatment for Grade 4, with corticosteroids and tocilizumab used as clinically indicated.
Participants will undergo screening within 21 days before the first dose. In Part A, participants will be admitted on Day -1, receive baseline PK/PD sampling before dosing, and remain at the study center until Day 3 for PK/PD sampling and safety assessment. Follow-up assessments of PK, PD, immunogenicity, efficacy, and safety will continue through Day 169. Participants with inadequate recovery of Cluster of Differentiation 19 positive （CD19+） B-cell counts after Day 85 may continue follow-up every 3 months for up to 6 months. In Part B, participants will receive 6 doses at 4-week intervals. They will remain at the study center through Day 3 after the first and final doses for PK/PD sampling and safety assessment; other dosing visits may be conducted on an outpatient basis or with 1-2 days of inpatient observation based on safety findings. After treatment completion, participants will undergo follow-up for 24 weeks to monitor CD19+ B-cell recovery, safety, PK/PD, immunogenicity, and clinical efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| JH013 injection, 15mg，single dose | Experimental | Biological: JH013 injection |
| JH013 injection, 45mg，single dose | Experimental | Biological: JH013 injection |
| JH013 injection, 90mg，single dose | Experimental | Biological: JH013 injection |
| JH013 injection, 150mg，single dose | Experimental | Biological: JH013 injection |
| JH013 injection, 225mg，single dose | Experimental | Biological: JH013 injection |
| JH013 injection, 315mg，single dose | Experimental | Biological: JH013 injection |
| JH013 injection, dose 1，multiple doses | Experimental | Biological: JH013 injection |
| JH013 injection, dose 2，multiple doses | Experimental | Biological: JH013 injection |
| JH013 injection, dose 3，multiple doses | Experimental | Biological: JH013 injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with primary Sjögren's syndrome (pSS) who meet the 2016 ACR/EULAR classification criteria for primary Sjögren's syndrome; 18 to 65 years of age (inclusive) for Part A and 18 to 75 years of age (inclusive) for Part B;
- EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥6 during the Screening Period;
- EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score ≥5 during the Screening Period;
- Elevated serological markers during the Screening Period, defined as an antinuclear antibody (ANA) titer ≥1:160 and positive rheumatoid factor (RF), or positive anti-SSA antibody (with or without anti-SSB antibody);
- Stimulated whole salivary flow rate ≥0.05 mL/min or unstimulated whole salivary flow rate ≥0.01 mL/min during the Screening Period;
Key exclusion criteria (33 listed)
- Secondary Sjögren's syndrome, defined as Sjögren's syndrome overlapping with another autoimmune disease or systemic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, or idiopathic inflammatory myopathy);
- Use of another investigational medicinal product within 5 half-lives or 30 days prior to Screening, whichever is longer, or within a period during which the expected pharmacodynamic effect has not returned to baseline, whichever is longer; or for a longer period if required for the investigational medicinal product;
- Use of B-cell-depleting therapies within 24 weeks prior to Screening (e.g., VAY736, rituximab, other anti-CD20 monoclonal antibodies, anti-CD22 monoclonal antibodies, or anti-CD52 monoclonal antibodies), or B-cell counts have not recovered to the lower limit of normal or baseline following prior B-cell-depleting therapy, whichever is lower;
- Receipt of any of the following prior treatments before Screening:
- Prednisone dose >10 mg/day, or any adjustment to the prednisone dose within 2 weeks prior to Screening;
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 |
|---|---|---|
| JH013 injectionAnti-B-cell Activating Factor Receptor（Anti-BAFFR） Monoclonal Antibody | Biological | JH013 injection, 150mg，single dose, JH013 injection, 15mg，single dose, JH013 injection, 225mg，single dose, JH013 injection, 315mg，single dose, JH013 injection, 45mg，single dose, JH013 injection, 90mg，single dose, JH013 injection, dose 1，multiple doses, JH013 injection, dose 2，multiple doses, JH013 injection, dose 3，multiple doses |
Primary outcome
Number of participants with adverse events（AEs）
Time frame: From day 1 to day 169
CACAE 6.0
Number of participants with adverse events（AEs）
Time frame: From Week 1 to Week 49
37 secondary outcomes
Pharmacokinetic parameters of JH013：Elimination half-life（t1/2）
Time frame: From day 1 to day 169
Pharmacokinetic parameters of JH013：Maximum observed plasma concentration（Cmax）
Time frame: From day 1 to day 169
Pharmacokinetic parameters of JH013：Time to maximum observed plasma concentration（Tmax)
Time frame: From day 1 to day 169
Pharmacokinetic parameters of JH013：Area under the plasma concentration-time curve from time zero to the last measurable concentration（AUC 0-t）
Time frame: From day 1 to day 169
Pharmacokinetic parameters of JH013：Area under the plasma concentration-time curve from time zero extrapolated to infinity（AUC0-∞）
Time frame: From day 1 to day 169
Pharmacokinetic parameters of JH013：Volume of distribution during the terminal phase（Vz）
Time frame: From day 1 to day 169
Pharmacokinetic parameters of JH013：Total body clearance（CL）
Time frame: From day 1 to day 169
Immunogenicity of JH013：Anti-drug antibody（ADA）
Time frame: From day 1 to day 169
Pharmacokinetic parameters of JH013：Time to maximum observed plasma concentration at steady state（Tss_max）
Time frame: From week 1 to week 32
Pharmacokinetic parameters of JH013：Maximum observed plasma concentration at steady state（Css_max）
Time frame: From week 1 to week 32
Pharmacokinetic parameters of JH013：Minimum observed plasma concentration at steady state（Css_min）
Time frame: From week 1 to week 32
Pharmacokinetic parameters of JH013：Area under the plasma concentration-time curve from time zero to the last measurable concentration at steady state（AUCss 0-t）
Time frame: From week 1 to week 32
Pharmacokinetic parameters of JH013：Area under the plasma concentration-time curve from time zero extrapolated to infinity at steady state（AUCss 0-∞）
Time frame: From week 1 to week 32
Pharmacokinetic parameters of JH013：Accumulation ratio based on AUC（RAUC）
Time frame: From week 1 to week 32
Pharmacokinetic parameters of JH013：Accumulation ratio based on Cmax（RCmax）
Time frame: From week 1 to week 32
Pharmacokinetic parameters of JH013：Apparent clearance at steady state（CL/Fss）
Time frame: From week 1 to week 32
Pharmacokinetic parameters of JH013：Apparent volume of distribution during the terminal phase at steady state（Vz/Fss）
Time frame: From week 1 to week 32
Pharmacokinetic parameters of JH013：Terminal elimination rate constant at steady state（Kelss）
Time frame: From week 1 to week 32
Pharmacokinetic parameters of JH013：Terminal half-life at steady state（t½ss）
Time frame: From week 1 to week 32
Pharmacokinetic parameters of JH013：Mean residence time（MRT）
Time frame: From week 1 to week 32
Pharmacokinetic parameters of JH013：Renal clearance（CLR）
Time frame: From week 1 to week 32
CD45+CD19+ B-cell count and percentage
Time frame: From week 1 to week 32
B-cell activating factor (BAFF) concentration
Time frame: From week 1 to week 32
JH013 antibody receptor occupancy (RO)
Time frame: From week 1 to week 32
CD45+CD3+ T-cell count and percentage
Time frame: From week 1 to week 32
Cytokines: IL-2, IL-4, IL-6, IL-10, TNF-α, and IFN-γ concentration
Time frame: From week 1 to week 32
Immunoglobulins (IgG, IgM, and IgA) concentration
Time frame: From week 1 to week 32
Complement C3 and complement C4 concentration
Time frame: From week 1 to week 32
Rheumatoid factor (RF) concentration
Time frame: From week 1 to week 32
Change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score
Time frame: Week 1 to Week 48
Change from baseline in the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score
Time frame: From Week 1 to Week 48
Change from baseline in the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) score
Time frame: From Week 1 to Week 48
Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score
Time frame: From Week 1 to Week 48
Change from baseline in Physician's Global Assessment (PhGA) score
Time frame: From Week 1 to Week 48
Change from baseline in unstimulated whole salivary flow rate
Time frame: From Week 1 to Week 48
Change from baseline in Schirmer I test score
Time frame: From Week 1 to Week 48
Change from baseline in Patient's Global Assessment (PaGA) score
Time frame: From Week 1 to Week 48
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 14 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JH013 injection in people with Primary Sjögren's Syndrome (pSS), run by Biotech Pharmaceutical Co., Ltd..
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 7 inclusion and 33 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events（AEs） (time frame: From day 1 to day 169). The study lists 2 primary outcomes in all. 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 14 Sep 2026.