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
12
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
NOT_YET_RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGHenan Children's Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGHunan Children's Hospital
Changsha, Hunan, China
RECRUITINGNanjing Children's Hospital
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGThe First Hospital of Jilin University
Changchun, Jilin, China
NOT_YET_RECRUITINGXi'an Children's Hospital
Xi'an, Shaanxi, China
NOT_YET_RECRUITINGChildren's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGChengdu Women's & Children's Central Hospital
Chengdu, Sichuan, China
RECRUITING...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