Clinical trial NCT05687526: A Study of Telitacicept in Subjects With Childhood-onset Systemic Lupus Erythematosus
Official title: A Phase 1, Open-label, Multi-center, Multiple-dose Study to Evaluate the Pharmacokinetics of Telitacicept in Subjects With Childhood-onset Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Keywords: systemic lupus erythematosus
pediatrics
PK
Lead sponsor: RemeGen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-18
Enrollment: 12
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Main Inclusion Criteria:

1. Fulfills SLICC 2012 or 2019 EULAR/ACR classification criteria for SLE.
2. 5-17 years of age when signing the informed consent.
3. Suject and/or legal guardian or parent provided written informed consent.
4. SELENA SLEDAI score ≥ 8 at screening.
5. Serum autoantibodies (ANA and/or anti ds-DNA) tested positive at screening.
6. Have been on a stable standard of care for SLE for at least 30 days prior to randomization.
7. Female patients are required to be non-pregnant, non-lactating or sterile.

Main Exclusion Criteria:

1. Have received Telitacicept at any time.
2. Have received any of the following therapies within 6 months of baseline: B-cell targeted treatment, e.g., belimumab, rituximab, abatacept, other investigational biologicals.
3. 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.
4. 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.
5. Have received live vaccine within 30 days of baseline.
6. Participated in an interventional clinical trial within 6 months of screening.
7. Active CNS lupus requiring treatment within 60 days of baseline, including seizure, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis or CNS vasculitis.
8. Currently on kidney replacement therapy (hemodialysis, peritoneal dialysis) or in need of such therapy within 90 days of baseline.
9. eGFR\<30 mL/min/1.73m2.
10. Acute severe nephritis.
11. History of vital organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
12. 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.

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.

Primary outcomes:
measure: Cmax of Telitacicept
timeFrame: up to 42 days following the last dose of Telitacicept
measure: tmax of Telitacicept
timeFrame: up to 42 days following the last dose of Telitacicept
measure: Ctrough of Telitacicept
timeFrame: up to 42 days following the last dose of Telitacicept
measure: Cav of Telitacicept
timeFrame: up to 42 days following the last dose of Telitacicept
measure: AUC0-t of Telitacicept
timeFrame: up to 42 days following the last dose of Telitacicept
measure: t1/2z of Telitacicept
timeFrame: up to 42 days following the last dose of Telitacicept
measure: λz of Telitacicept
timeFrame: up to 42 days following the last dose of Telitacicept
Secondary outcomes:
measure: SLE Responder Index 4 (SRI 4)
timeFrame: Week 4, Week 8, Week 12
measure: Proportion of subjects with SELENA-SLEDAI score reduced from baseline by at least 4 points.
timeFrame: Week 4, Week 8, Week 12
measure: Change from baseline in PGA.
timeFrame: Week 4, Week 8, Week 12
measure: Change From Baseline in IgG
timeFrame: Week 4, Week 8, Week 12
measure: Change From Baseline in IgA
timeFrame: Week 4, Week 8, Week 12
measure: Change From Baseline in IgM
timeFrame: Week 4, Week 8, Week 12
measure: Change From Baseline in C3
timeFrame: Week 4, Week 8, Week 12
measure: Change From Baseline in C4
timeFrame: Week 4, Week 8, Week 12
measure: Incidence of AEs
timeFrame: up to Week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Children's Hospital of Capital Institute of Pediatrics
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
city: Zhengzhou
country: China
facility: Henan Children's Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Children's Hospital
state: Hunan
city: Nanjing
country: China
facility: Nanjing Children's Hospital
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Xi'an
country: China
facility: Xi'an Children's Hospital
state: Shaanxi
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Chengdu
country: China
facility: Chengdu Women's & Children's Central Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Children's Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Peking Union Medical College Hospital
name: Hongmei Song, M.D.
role: PRINCIPAL_INVESTIGATOR
References: