Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)
Primary Purpose
Systemic Lupus Erythematosus
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Belimumab
Standard therapy
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Pediatric, Belimumab, Pharmacokinetics, Active Systemic Lupus Erythematosus, Safety, Efficacy
Eligibility Criteria
Inclusion criteria:
- Participants have or have had in series, 4 or more of the American College of Rheumatology (ACR) 11 criteria for the classification of SLE.
- Participant's age is 5 to 17 years at the time of informed consent.
- Have active SLE disease defined as a SELENA SLEDAI score >= 8 at screening (SELENA SLEDAI scoring).
- Have unequivocally positive autoantibody test results defined as an anti-nuclear antibody (ANA) titer >=1:80 and/or a positive anti-Double stranded deoxyribonucleic acid (dsDNA) serum antibody test.
- Are on a stable SLE therapy at Baseline. The stable treatment at Baseline consists of corticosteroids, anti-malarials, immunosuppressive/immunomodulatory agents and Non-steroidal anti-inflammatory drugs (NSAIDs), alone or in combination, at a fixed dose for a period of at least 30 days prior to Day 0.
- No gender restriction. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- The investigator, or a person designated by the investigator, will obtain written informed assent from each study participant or the participant's legally acceptable representative, parent(s), or legal guardian and the participant's assent, when applicable, before any study-specific activity is performed. The investigator will retain the original copy of each participant's signed assent document.
Exclusion Criteria:
- Have an estimated glomerular filtration rate (eGFR) as calculated by Schwartz Formula of less than 30 mL/minutes.
- Have acute severe nephritis defined as a significant worsening of renal disease (for example [e.g.], the presence of urinary sediments and other lab abnormalities) that, in the opinion of the study investigator, may lead to the participant requiring induction therapy with intravenous (IV) cyclophosphamide, Mycophenolate mofetil (MMF) or high dose corticosteroids during the first 6 months of the study.
- Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
- Have clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk.
- Have a planned surgical procedure or a history of any other medical disease (e.g., cardiopulmonary), laboratory abnormality, or condition (e.g., poor venous access) that, in the opinion of the investigator, makes the participant unsuitable for the study.
- Have a history of malignant neoplasm within the last 5 years.
- Have a history of a primary immunodeficiency.
- Have an Immunoglobulin A (IgA) deficiency (IgA level less than [<]10 mg/deciliters [milligrams/dL]).
- Have acute or chronic infections requiring management.
- Have recent infections that, in the opinions of the investigator, makes the participant unsuitable for the study or could put the participant at undue risk.
- Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 0.
Have a Grade 3 or greater laboratory abnormality based on the protocol toxicity scale except for the following that are allowed:
- Stable Grade 3 prothrombin time (PT) secondary to warfarin treatment.
- Stable Grade 3 partial thromboplastin time (PTT) due to lupus anticoagulant and not related to liver disease or anti-coagulant therapy.
- Stable Grade 3 hypoalbuminemia due to lupus nephritis and not related to liver disease or malnutrition.
- Any grade proteinuria
- Stable Grade 3 gamma glutamyl transferase (GGT) elevation due to lupus hepatitis and not related to alcoholic liver disease, uncontrolled diabetes or viral hepatitis. If present, any abnormalities in the Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) must be Grade 2.
- Stable Grade 3 neutropenia; or stable Grade 3 lymphopenia; or stable Grade 3 leukopenia, due to SLE
- Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
- Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months or who in the investigator's judgment, poses a significant suicide risk.
- Have received treatment with belimumab at any time.
Have received any of the following within 364 days of Day 0:
- Treatment with any B-cell targeted
- Abatacept
- A biologic investigational agent
- Have required 3 or more courses of systemic corticosteroids for concomitant conditions (e.g., asthma, atopic dermatitis) within 90 days of Day 0.
Have received any of the following within 90 days of Day 0:
- Anti-Tumour Necrosis Factor (TNF) or anti-interleukin (IL)-6 therapy (e.g., adalimumab, etanercept, infliximab, tocilizumab certolizumab, golimumab)
- Interleukin-1 receptor antagonist (anakinra)
- Intravenous immunoglobulin (IVIG)
- Plasmapheresis
Have received any of the following within 30 days of Day 0:
- IV cyclophosphamide
- A non-biologic investigational agent (30 days window OR 5 half-lives, whichever is longer)
- Any new immunosuppressive/immunomodulatory agent, anti-malarial, NSAID
- High dose prednisone or equivalent (>1.5 mg/kilogram/day) or any intramuscular or intravenous steroid injection.
- Have received a live or live-attenuated vaccine within 30 days of Day 0.
- Have active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis or CNS vasculitis) requiring therapeutic intervention within 60 days of Day 0.
- Have required renal replacement therapy (e.g., hemodialysis, peritoneal dialysis) within 90 days of Day 0 or be currently on renal replacement therapy.
- Participation in an interventional clinical study either concurrently or within 6 months of screening. Participation in an observational study may be permitted.
- Have a historically positive test or test positive at screening for Human immunodeficiency virus (HIV) antibody.
- Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posteroanterior) and a positive (not indeterminate) QuantiFERON-TB Gold Plus test.
- Hepatitis B: Serologic evidence of Hepatitis B (HB) infection defined as Hepatitis B surface antigen positive (HBsAg+) or Hepatitis B core antibody positive (HBcAb+).
- Hepatitis C: Positive test for Hepatitis C antibody at screening.
Sites / Locations
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
- GSK Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pediatric participants receiving belimumab
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with Adverse events of special interest (AESIs)
Participants with adverse events of special interest (AESIs) including all infections of serious infections of special interest and opportunistic infections, infusion related systemic reactions and anaphylactic reactions, depression, suicidality, and malignancies will be evaluated.
Number of participants with greater than equal to (>=) 4 points reduction from Baseline in Safety of Estrogen in Lupus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI)
The SELENA SLEDAI score is a cumulative and weighted index for assessing SLE disease activity across 24 different disease descriptors in participants with SLE. This assessment can be completed to objectively assess the participant's current state of disease. A total score of SELENA SLEDAI can fall between 0 and 105 with a higher score indicating a more significant degree of disease activity.
Secondary Outcome Measures
Number of participants with Adverse events (AEs) and Serious adverse events (SAEs)
Number of participants with >=4 points reduction from Baseline in SELENA SLEDAI by each visit
Change from Baseline in Physician Global Assessment (PGA)
The PGA will be used to assess participant's current disease activity by investigator. It is collected on a 10 centimeter (cm) Visual analogue scale, scoring ranges from 0 (no activity) to 3 (severe activity). Lower means no disease activity, higher score means severe disease activity.
Change from Baseline in Parent Global Assessment (ParentGA)
The ParentGA will assess the participant's overall well-being at the moment rated on a 21-numbered circle visual analog scale. The scale will range from 0 (very well) to 10 (very poorly). Higher score will indicate worse effect of the illness on the child.
Change from Baseline in daily prednisone equivalent dose
Time to first flare
Time to first severe flare
Plasma concentration of belimumab
Apparent total clearance of belimumab (C/L)
Volume of distribution of belimumab
Terminal half-life (t1/2) of belimumab
Estimated maximum concentration (Cmax) of belimumab at steady state
Estimated minimum concentration (Cmin) of belimumab at steady state
Estimated average concentration (Cavg) of belimumab at steady state
Area under plasma concentration-time curve (AUC) of belimumab at steady state
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04908865
Brief Title
Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)
Official Title
A Multi-Center, Open-Label Study to Evaluate Safety, Efficacy and Pharmacokinetics of Belimumab Plus Standard Therapy in Chinese Paediatric Patients With Active Systemic Lupus Erythematosus (SLE)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2021 (Actual)
Primary Completion Date
June 12, 2024 (Anticipated)
Study Completion Date
September 4, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
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 study will be conducted to evaluate the safety, efficacy and pharmacokinetics of belimumab administered in combination with background standard therapy in pediatric participants with active SLE.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Pediatric, Belimumab, Pharmacokinetics, Active Systemic Lupus Erythematosus, Safety, Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pediatric participants receiving belimumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Belimumab
Intervention Description
Belimumab will be administered.
Intervention Type
Drug
Intervention Name(s)
Standard therapy
Intervention Description
Standard therapy will be continued.
Primary Outcome Measure Information:
Title
Number of participants with Adverse events of special interest (AESIs)
Description
Participants with adverse events of special interest (AESIs) including all infections of serious infections of special interest and opportunistic infections, infusion related systemic reactions and anaphylactic reactions, depression, suicidality, and malignancies will be evaluated.
Time Frame
Up to Week 52
Title
Number of participants with greater than equal to (>=) 4 points reduction from Baseline in Safety of Estrogen in Lupus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI)
Description
The SELENA SLEDAI score is a cumulative and weighted index for assessing SLE disease activity across 24 different disease descriptors in participants with SLE. This assessment can be completed to objectively assess the participant's current state of disease. A total score of SELENA SLEDAI can fall between 0 and 105 with a higher score indicating a more significant degree of disease activity.
Time Frame
Up to Week 52
Secondary Outcome Measure Information:
Title
Number of participants with Adverse events (AEs) and Serious adverse events (SAEs)
Time Frame
Up to Week 52
Title
Number of participants with >=4 points reduction from Baseline in SELENA SLEDAI by each visit
Time Frame
Up to Week 52
Title
Change from Baseline in Physician Global Assessment (PGA)
Description
The PGA will be used to assess participant's current disease activity by investigator. It is collected on a 10 centimeter (cm) Visual analogue scale, scoring ranges from 0 (no activity) to 3 (severe activity). Lower means no disease activity, higher score means severe disease activity.
Time Frame
Baseline and up to Week 52
Title
Change from Baseline in Parent Global Assessment (ParentGA)
Description
The ParentGA will assess the participant's overall well-being at the moment rated on a 21-numbered circle visual analog scale. The scale will range from 0 (very well) to 10 (very poorly). Higher score will indicate worse effect of the illness on the child.
Time Frame
Baseline and up to Week 52
Title
Change from Baseline in daily prednisone equivalent dose
Time Frame
Baseline and up to Week 52
Title
Time to first flare
Time Frame
Up to Week 52
Title
Time to first severe flare
Time Frame
Up to Week 52
Title
Plasma concentration of belimumab
Time Frame
At Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84
Title
Apparent total clearance of belimumab (C/L)
Time Frame
Up to Week 12
Title
Volume of distribution of belimumab
Time Frame
Up to Week 12
Title
Terminal half-life (t1/2) of belimumab
Time Frame
Up to Week 12
Title
Estimated maximum concentration (Cmax) of belimumab at steady state
Time Frame
Up to Week 12
Title
Estimated minimum concentration (Cmin) of belimumab at steady state
Time Frame
Up to Week 12
Title
Estimated average concentration (Cavg) of belimumab at steady state
Time Frame
Up to Week 12
Title
Area under plasma concentration-time curve (AUC) of belimumab at steady state
Time Frame
Up to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Participants have or have had in series, 4 or more of the American College of Rheumatology (ACR) 11 criteria for the classification of SLE.
Participant's age is 5 to 17 years at the time of informed consent.
Have active SLE disease defined as a SELENA SLEDAI score >= 8 at screening (SELENA SLEDAI scoring).
Have unequivocally positive autoantibody test results defined as an anti-nuclear antibody (ANA) titer >=1:80 and/or a positive anti-Double stranded deoxyribonucleic acid (dsDNA) serum antibody test.
Are on a stable SLE therapy at Baseline. The stable treatment at Baseline consists of corticosteroids, anti-malarials, immunosuppressive/immunomodulatory agents and Non-steroidal anti-inflammatory drugs (NSAIDs), alone or in combination, at a fixed dose for a period of at least 30 days prior to Day 0.
No gender restriction. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
The investigator, or a person designated by the investigator, will obtain written informed assent from each study participant or the participant's legally acceptable representative, parent(s), or legal guardian and the participant's assent, when applicable, before any study-specific activity is performed. The investigator will retain the original copy of each participant's signed assent document.
Exclusion Criteria:
Have an estimated glomerular filtration rate (eGFR) as calculated by Schwartz Formula of less than 30 mL/minutes.
Have acute severe nephritis defined as a significant worsening of renal disease (for example [e.g.], the presence of urinary sediments and other lab abnormalities) that, in the opinion of the study investigator, may lead to the participant requiring induction therapy with intravenous (IV) cyclophosphamide, Mycophenolate mofetil (MMF) or high dose corticosteroids during the first 6 months of the study.
Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
Have clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk.
Have a planned surgical procedure or a history of any other medical disease (e.g., cardiopulmonary), laboratory abnormality, or condition (e.g., poor venous access) that, in the opinion of the investigator, makes the participant unsuitable for the study.
Have a history of malignant neoplasm within the last 5 years.
Have a history of a primary immunodeficiency.
Have an Immunoglobulin A (IgA) deficiency (IgA level less than [<]10 mg/deciliters [milligrams/dL]).
Have acute or chronic infections requiring management.
Have recent infections that, in the opinions of the investigator, makes the participant unsuitable for the study or could put the participant at undue risk.
Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 0.
Have a Grade 3 or greater laboratory abnormality based on the protocol toxicity scale except for the following that are allowed:
Stable Grade 3 prothrombin time (PT) secondary to warfarin treatment.
Stable Grade 3 partial thromboplastin time (PTT) due to lupus anticoagulant and not related to liver disease or anti-coagulant therapy.
Stable Grade 3 hypoalbuminemia due to lupus nephritis and not related to liver disease or malnutrition.
Any grade proteinuria
Stable Grade 3 gamma glutamyl transferase (GGT) elevation due to lupus hepatitis and not related to alcoholic liver disease, uncontrolled diabetes or viral hepatitis. If present, any abnormalities in the Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) must be Grade 2.
Stable Grade 3 neutropenia; or stable Grade 3 lymphopenia; or stable Grade 3 leukopenia, due to SLE
Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months or who in the investigator's judgment, poses a significant suicide risk.
Have received treatment with belimumab at any time.
Have received any of the following within 364 days of Day 0:
Treatment with any B-cell targeted
Abatacept
A biologic investigational agent
Have required 3 or more courses of systemic corticosteroids for concomitant conditions (e.g., asthma, atopic dermatitis) within 90 days of Day 0.
Have received any of the following within 90 days of Day 0:
Anti-Tumour Necrosis Factor (TNF) or anti-interleukin (IL)-6 therapy (e.g., adalimumab, etanercept, infliximab, tocilizumab certolizumab, golimumab)
Interleukin-1 receptor antagonist (anakinra)
Intravenous immunoglobulin (IVIG)
Plasmapheresis
Have received any of the following within 30 days of Day 0:
IV cyclophosphamide
A non-biologic investigational agent (30 days window OR 5 half-lives, whichever is longer)
Any new immunosuppressive/immunomodulatory agent, anti-malarial, NSAID
High dose prednisone or equivalent (>1.5 mg/kilogram/day) or any intramuscular or intravenous steroid injection.
Have received a live or live-attenuated vaccine within 30 days of Day 0.
Have active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis or CNS vasculitis) requiring therapeutic intervention within 60 days of Day 0.
Have required renal replacement therapy (e.g., hemodialysis, peritoneal dialysis) within 90 days of Day 0 or be currently on renal replacement therapy.
Participation in an interventional clinical study either concurrently or within 6 months of screening. Participation in an observational study may be permitted.
Have a historically positive test or test positive at screening for Human immunodeficiency virus (HIV) antibody.
Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posteroanterior) and a positive (not indeterminate) QuantiFERON-TB Gold Plus test.
Hepatitis B: Serologic evidence of Hepatitis B (HB) infection defined as Hepatitis B surface antigen positive (HBsAg+) or Hepatitis B core antibody positive (HBcAb+).
Hepatitis C: Positive test for Hepatitis C antibody at screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410007
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Zhihui Li
Facility Name
GSK Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Haiguo Yu
Facility Name
GSK Investigational Site
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215007
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Qihua Feng
Facility Name
GSK Investigational Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Sirui Yang
Facility Name
GSK Investigational Site
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710054
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Xiaoqing Li
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100045
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Caifeng Li
Facility Name
GSK Investigational Site
City
Chongqing
ZIP/Postal Code
400014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Xuemei Tang
Facility Name
GSK Investigational Site
City
Hangzhou
ZIP/Postal Code
310052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Meiping Lu
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
361006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Li Sun
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
http://clinicalstudydatarequest.com
Learn more about this trial
Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)
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