A Study of Telitacicept in Subjects With Childhood-onset Systemic Lupus Erythematosus
- Registration Number
- NCT05687526
- Lead Sponsor
- RemeGen Co., Ltd.
- Brief Summary
This is a multi-center, open-label, phase 1 study.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12
- Fulfills SLICC 2012 or 2019 EULAR/ACR classification criteria for SLE.
- 12-17 years of age when signing the informed consent.
- Parent or legal guardian provided written informed consent.
- SELENA SLEDAI score ≥ 8 at screening.
- Serum autoantibodies (ANA and/or anti ds-DNA) tested positive at screening.
- Have been on a stable standard of care for SLE for at least 30 days prior to randomization.
Main
- Have received Telitacicept at any time.
- Have received any of the following therapies within 6 months of baseline: B-cell targeted treatment, e.g., belimumab, rituximab, abatacept, other investigational biologicals.
- Have received any of the following therapies within 90 days of baseline: anti-TNF or anti-IL-6 therapy, interleukin-1 receptor antagonist, intravenous immunoglobulin (IVIG), plasmapheresis.
- Have received any of the following therapies within 30 days of baseline: Intravenous cyclophosphamide, non-biological investigational agents (within 30 days of baseline or 5 half-lives, whichever is longer), newly added immunosuppressive/immunomodulatory agent, anti-malarial, NSAID, high-dose prednisone or equivalent (> 1.5 mg/kg/day) or any intramuscular or intravenous steroid.
- Have received live vaccine within 30 days of baseline.
- Participated in an interventional clinical trial within 6 months of screening.
- Active CNS lupus requiring treatment within 60 days of baseline, including seizure, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis or CNS vasculitis.
- Currently on kidney replacement therapy (hemodialysis, peritoneal dialysis) or in need of such therapy within 90 days of baseline.
- eGFR<30 mL/min/1.73m2.
- Acute severe nephritis.
- History of vital organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
- Significant unstable or uncontrolled acute or chronic diseases (cardiovascular, lung, hematology, gastrointestinal, liver, renal, neurologic, malignancy or infectious disease) that could be explained by causes other than SLE.
- History of malignant neoplasm in the past 5 years.
- Primary immune deficiency.
- Acute or chronic infections requiring treatment.
- HIV/HCV/HBsAg/HBcAb positive.
- Tuberculosis.
- Have planned surgery, laboratory abnormalities, other diseases or conditions that, in the opinion of the investigator, makes the subject unsuitable for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Telitacicept Telitacicept The dosing of Telitacicept frequency was based on body weight and age.
- Primary Outcome Measures
Name Time Method AUC0-t of Telitacicept up to 42 days following the last dose of Telitacicept AUC0-t is defined as area under the curve from time zero to last quantifiable concentration of Telitacicept
tmax of Telitacicept up to 42 days following the last dose of Telitacicept tmax is defined as time to reach Cmax of Telitacicept
Cmax of Telitacicept up to 42 days following the last dose of Telitacicept Cmax is defined as peak plasma concentration of Telitacicept
Ctrough of Telitacicept up to 42 days following the last dose of Telitacicept Ctrough is defined as observed plasma concentration of Telitacicept just prior to the beginning of a dosing interval
Cav of Telitacicept up to 42 days following the last dose of Telitacicept Average concentration of Telitacicept
t1/2z of Telitacicept up to 42 days following the last dose of Telitacicept t1/2z is defined as terminal elimination half-life of Telitacicept
λz of Telitacicept up to 42 days following the last dose of Telitacicept λz is defined as terminal elimination rate constant
- Secondary Outcome Measures
Name Time Method Change From Baseline in IgM Week 4, Week 8, Week 12 Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.
Change From Baseline in C4 Week 4, Week 8, Week 12 Complement (C3/C4) are proteins that are part of the immune system.
SLE Responder Index 4 (SRI 4) Week 4, Week 8, Week 12 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.
Proportion of subjects with SELENA-SLEDAI score reduced from baseline by at least 4 points. Week 4, Week 8, Week 12 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.
Change from baseline in PGA. Week 4, Week 8, Week 12 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.
Change From Baseline in IgG Week 4, Week 8, Week 12 Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.
Change From Baseline in IgA Week 4, Week 8, Week 12 Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.
Change From Baseline in C3 Week 4, Week 8, Week 12 Complement (C3/C4) are proteins that are part of the immune system.
Incidence of AEs up to Week 12 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.
Trial Locations
- Locations (12)
Children's Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Chengdu Women's & Children's Central Hospital
🇨🇳Chengdu, Sichuan, China
Xi'an Children's Hospital
🇨🇳Xi'an, Shaanxi, China
Children's Hospital of Capital Institute of Pediatrics
🇨🇳Beijing, Beijing, China
Hunan Children's Hospital
🇨🇳Changsha, Hunan, China
Nanjing Children's Hospital
🇨🇳Nanjing, Jiangsu, China
Henan Children's Hospital
🇨🇳Zhengzhou, Henan, China
Children's Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
The Second Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Children's Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China