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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
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.
Children's Hospital of Capital Institute of Pediatrics
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Cmax of Telitacicept
Cmax is defined as peak plasma concentration of Telitacicept
Time frame: up to 42 days following the last dose of Telitacicept
tmax of Telitacicept
tmax is defined as time to reach Cmax of Telitacicept
Time frame: 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
Time frame: up to 42 days following the last dose of Telitacicept
Cav of Telitacicept
Average concentration of Telitacicept
Time frame: 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
Time frame: 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
Time frame: up to 42 days following the last dose of Telitacicept
λz of Telitacicept
λz is defined as terminal elimination rate constant
Time frame: up to 42 days following the last dose of Telitacicept
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.
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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
...and 2 more locations
Time frame: Week 4, Week 8, Week 12
Proportion of subjects with SELENA-SLEDAI score reduced from baseline by at least 4 points.
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.
Time frame: 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.
Time frame: Week 4, Week 8, Week 12
Change From Baseline in IgG
Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.
Time frame: Week 4, Week 8, Week 12
Change From Baseline in IgA
Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.
Time frame: Week 4, Week 8, Week 12
Change From Baseline in IgM
Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.
Time frame: Week 4, Week 8, Week 12
Change From Baseline in C3
Complement (C3/C4) are proteins that are part of the immune system.
Time frame: Week 4, Week 8, Week 12
Change From Baseline in C4
Complement (C3/C4) are proteins that are part of the immune system.
Time frame: 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.
Time frame: up to Week 12