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This is a multi-center, open-label, phase 1 study.
The purpose of this study is to evaluate the pharmacokinetics (PK) of multiple doses of Telitacicept in subjects with childhood-onset systemic lupus erythematosus (cSLE) on a background of standard of care therapy and explore the safety and efficacy of Telitacicept in patients with cSLE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telitacicept | Experimental | The dosing of Telitacicept frequency was based on body weight and age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telitacicept | Biological | 12-17 years old: Telitacicept 2.5 mg/kg (with a maximum dose of 160 mg) subcutaneously once a week plus SOC for 12 weeks. 5-11years old: Telitacicept 3.0-3.5 mg/kg (with a maximum dose of 160 mg) subcutaneously once a week plus SOC for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Telitacicept | Cmax is defined as peak plasma concentration of Telitacicept | up to 42 days following the last dose of Telitacicept |
| tmax of Telitacicept | tmax is defined as time to reach Cmax of Telitacicept | up to 42 days following the last dose of Telitacicept |
| Ctrough of Telitacicept | Ctrough is defined as observed plasma concentration of Telitacicept just prior to the beginning of a dosing interval | up to 42 days following the last dose of Telitacicept |
| Cav of Telitacicept | Average concentration of Telitacicept | up to 42 days following the last dose of Telitacicept |
| AUC0-t of Telitacicept | AUC0-t is defined as area under the curve from time zero to last quantifiable concentration of Telitacicept | up to 42 days following the last dose of Telitacicept |
| t1/2z of Telitacicept | t1/2z is defined as terminal elimination half-life of Telitacicept | up to 42 days following the last dose of Telitacicept |
| λz of Telitacicept | λz is defined as terminal elimination rate constant | up to 42 days following the last dose of Telitacicept |
| Measure | Description | Time Frame |
|---|---|---|
| SLE Responder Index 4 (SRI 4) | SRI 4 is defined as a. SELENA-SLEDAI score reduced from baseline by at least 4 points; b. no new BILAG A or no more than 1 BILAG B compared to baseline; c. physician's global assessment (PGA) increased from baseline by less than 0.3 points. | Week 4, Week 8, Week 12 |
| Proportion of subjects with SELENA-SLEDAI score reduced from baseline by at least 4 points. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
13 Have planned surgery, laboratory abnormalities, other diseases or conditions that, in the opinion of the investigator, makes the subject unsuitable for the study.
14. History of malignant neoplasm in the past 5 years. 15. Primary immune deficiency. 16. Acute or chronic infections requiring treatment. 17. HIV or HCV positive. 18. Tuberculosis. 19.HBsAg/HbcAb positive. 20.HBcAb positive. 21.History of COVID-19 within 4 weeks prior to screening. 22.History of hospitalization due to severe Covid-19 within 12 months prior to screening.
23.History of allergy to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
24.History of drug or alcohol abuse or dependence within 364 days prior to baseline.
25.Investigators believe that there are other factors that are not suitable for participating in the experiment.
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| Name | Affiliation | Role |
|---|---|---|
| Hongmei Song, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Capital Institute of Pediatrics | Beijing | Beijing Municipality | China | |||
| Peking Union Medical College Hospital |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000722462 | telitacicept |
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|
The SELENA-SLEDAI is a tool for measuring the activity of systemic lupus. The total score ranges from 0-105, with a higher score representing a more significant degree of disease activity. |
| Week 4, Week 8, Week 12 |
| Change from baseline in PGA. | The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity. | Week 4, Week 8, Week 12 |
| Change From Baseline in IgG | Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells. | Week 4, Week 8, Week 12 |
| Change From Baseline in IgA | Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells. | Week 4, Week 8, Week 12 |
| Change From Baseline in IgM | Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells. | Week 4, Week 8, Week 12 |
| Change From Baseline in C3 | Complement (C3/C4) are proteins that are part of the immune system. | Week 4, Week 8, Week 12 |
| Change From Baseline in C4 | Complement (C3/C4) are proteins that are part of the immune system. | Week 4, Week 8, Week 12 |
| Incidence of AEs | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | up to Week 12 |
| Beijing |
| Beijing Municipality |
| China |
| Children's Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| Henan Children's Hospital | Zhengzhou | Henan | China |
| Hunan Children's Hospital | Changsha | Hunan | China |
| Nanjing Children's Hospital | Nanjing | Jiangsu | China |
| The First Hospital of Jilin University | Changchun | Jilin | China |
| Xi'an Children's Hospital | Xi'an | Shaanxi | China |
| Children's Hospital of Fudan University | Shanghai | Shanghai Municipality | China |
| Chengdu Women's & Children's Central Hospital | Chengdu | Sichuan | China |
| Children's Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China |