Back to resultsA Study of Telitacicept in Subjects With Childhood-onset Systemic Lupus Erythematosus
Primary Purpose
Systemic Lupus Erythematosus
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Telitacicept 2.5 mg/kg
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring systemic lupus erythematosus, pediatrics, PK
Eligibility Criteria
Main Inclusion Criteria: 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 Exclusion Criteria: 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.
Sites / Locations
- Children's Hospital of Capital Institute of Pediatrics
- Peking Union Medical College Hospital
- Children's Hospital of Chongqing Medical University
- Henan Children's Hospital
- Hunan Children's HospitalRecruiting
- Nanjing Children's Hospital
- The First Hospital of Jilin University
- Xi'an Children's Hospital
- Children's Hospital of Fudan University
- Chengdu Women's & Children's Central HospitalRecruiting
- Children's Hospital of Zhejiang University School of MedicineRecruiting
- The Second Affiliated Hospital of Wenzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Telitacicept 2.5 mg/kg
Arm Description
Telitacicept 2.5 mg/kg
Outcomes
Primary Outcome Measures
Cmax of Telitacicept
Cmax is defined as peak plasma concentration of Telitacicept
tmax of Telitacicept
tmax is defined as time to reach Cmax of Telitacicept
Ctrough of Telitacicept
Ctrough is defined as observed plasma concentration of Telitacicept just prior to the beginning of a dosing interval
Cav of Telitacicept
Average concentration of Telitacicept
AUC0-t of Telitacicept
AUC0-t is defined as area under the curve from time zero to last quantifiable concentration of Telitacicept
t1/2z of Telitacicept
t1/2z is defined as terminal elimination half-life of Telitacicept
λz of Telitacicept
λz is defined as terminal elimination rate constant
Secondary Outcome Measures
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.
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.
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.
Change From Baseline in IgG
Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.
Change From Baseline in IgA
Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.
Change From Baseline in IgM
Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.
Change From Baseline in C3
Complement (C3/C4) are proteins that are part of the immune system.
Change From Baseline in C4
Complement (C3/C4) are proteins that are part of the immune system.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05687526
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RemeGen Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
systemic lupus erythematosus, pediatrics, PK
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telitacicept 2.5 mg/kg
Arm Type
Experimental
Arm Description
Telitacicept 2.5 mg/kg
Intervention Type
Biological
Intervention Name(s)
Telitacicept 2.5 mg/kg
Other Intervention Name(s)
RC18
Intervention Description
Subjects will be given Telitacicept 2.5 mg/kg (with a maximum dose of 160 mg) subcutaneously once a week plus SOC for 12 weeks.
Primary Outcome Measure Information:
Title
Cmax of Telitacicept
Description
Cmax is defined as peak plasma concentration of Telitacicept
Time Frame
up to 42 days following the last dose of Telitacicept
Title
tmax of Telitacicept
Description
tmax is defined as time to reach Cmax of Telitacicept
Time Frame
up to 42 days following the last dose of Telitacicept
Title
Ctrough of Telitacicept
Description
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
Title
Cav of Telitacicept
Description
Average concentration of Telitacicept
Time Frame
up to 42 days following the last dose of Telitacicept
Title
AUC0-t of Telitacicept
Description
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
Title
t1/2z of Telitacicept
Description
t1/2z is defined as terminal elimination half-life of Telitacicept
Time Frame
up to 42 days following the last dose of Telitacicept
Title
λz of Telitacicept
Description
λz is defined as terminal elimination rate constant
Time Frame
up to 42 days following the last dose of Telitacicept
Secondary Outcome Measure Information:
Title
SLE Responder Index 4 (SRI 4)
Description
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.
Time Frame
Week 4, Week 8, Week 12
Title
Proportion of subjects with SELENA-SLEDAI score reduced from baseline by at least 4 points.
Description
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
Title
Change from baseline in PGA.
Description
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
Title
Change From Baseline in IgG
Description
Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.
Time Frame
Week 4, Week 8, Week 12
Title
Change From Baseline in IgA
Description
Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.
Time Frame
Week 4, Week 8, Week 12
Title
Change From Baseline in IgM
Description
Immunoglobulins (IgG, IgA and IgM) are proteins produced by plasma cells.
Time Frame
Week 4, Week 8, Week 12
Title
Change From Baseline in C3
Description
Complement (C3/C4) are proteins that are part of the immune system.
Time Frame
Week 4, Week 8, Week 12
Title
Change From Baseline in C4
Description
Complement (C3/C4) are proteins that are part of the immune system.
Time Frame
Week 4, Week 8, Week 12
Title
Incidence of AEs
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
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 Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Binghua Xiao
Phone
86-101-58076833
Email
binghua.xiao@remegen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongmei Song, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Capital Institute of Pediatrics
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Children's Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Henan Children's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Hunan Children's Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing Children's Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Xi'an Children's Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Chengdu Women's & Children's Central Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study of Telitacicept in Subjects With Childhood-onset Systemic Lupus Erythematosus
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