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A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Belimumab
Standard of care
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Belimumab, Pediatric, Pharmacokinetics, Systemic Lupus Erythematosus

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants between 5 and 17 years of age inclusive, at the time of informed consent Chinese pediatric participants with SLE, who have completed 48 weeks treatment in study 213560 and who, in the opinion of the investigator, may benefit from treatment with GSK1550188. Body weight greater than equal to >=15 kilograms (kg), at the time of signing the informed consent. Male and/or female: No contraceptive measures are required for male participants. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: i) Is a woman of non-childbearing potential OR ii) Is a woman of childbearing potential and using a contraceptive method that is highly effective, with a failure rate of <1% Participant signs and dates a written age-appropriate assent form (in accordance with applicable regulations) and the parent or legal guardian (or emancipated minor) that has the ability to understand the requirements of the study, provides written informed consent (including consent for the use and disclosure of research-related health information) that the participant will comply with the study protocol procedures (including required study visits). Exclusion Criteria: Participants who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an Adverse events (AE) in 213560 study that could, in the opinion of the principal investigator, put the participant at undue risk. Have developed any other medical diseases (e.g., cardiopulmonary), laboratory abnormalities, or conditions that, in the opinion of the principal investigator, makes the participant unsuitable for the study. Have an estimated glomerular filtration rate as calculated by Schwartz Formula of less than 30 milliliter per minute (mL/min). Have an Immunoglobulin A (IgA) deficiency (IgA level <10 milli gram per deciliter [mg/dL]). Have a Grade 3 or greater laboratory abnormality based on the protocol toxicity scale except for the following that are allowed: 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 transaminase (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. Developing a positive test for Human immunodeficiency virus (HIV) antibody after inclusion into 213560, per investigator's discretion according to clinical need. Developing hepatitis B: Serologic evidence of Hepatitis B (HB) infection defined as Hepatitis B surface antigen positive (HBsAg+) OR Hepatitis B core antibody positive (HBcAb+) after inclusion into 213560, per investigator's discretion according to clinical need. Developing a positive test for Hepatitis C antibody after inclusion into 213560, per investigator's discretion according to clinical need. Have received a live or live-attenuated vaccine within 30 Days of Day 1. Are unable or unlikely, in the opinion of the investigator, to administer belimumab by SC injection and have no reliable source to administer the injection.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Participants receiving belimumab + Standard of care (SOC)

    Arm Description

    Participants will receive belimumab 200 milligrams SC injection according the Baseline body weight plus SOC.

    Outcomes

    Primary Outcome Measures

    Area under the curve at steady-state to the end of the dosing period (AUCss, 0-tau) of belimumab
    Average serum concentration at steady state (Cavg, ss) of belimumab
    Minimum serum concentrations at steady state (Cmin, ss) of belimumab
    Maximum serum concentrations during the dosing interval at steady state (Cmax, ss) of belimumab

    Secondary Outcome Measures

    Number of participants with serious adverse events and non-serious adverse events
    Number of participants with adverse events of special interest (AESIs)

    Full Information

    First Posted
    June 14, 2023
    Last Updated
    June 14, 2023
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05917288
    Brief Title
    A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus
    Official Title
    A Multi-Centre, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subcutaneously Administered Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Systemic Lupus Erythematosus (SLE)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 29, 2023 (Anticipated)
    Primary Completion Date
    January 4, 2025 (Anticipated)
    Study Completion Date
    January 4, 2025 (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 evaluate the pharmacokinetic characteristics and safety of belimumab subcutaneous (SC) in Chinese pediatric participants with SLE who have completed 48 weeks belimumab Intravenous (IV) treatment in 213560 study (NCT04908865)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systemic Lupus Erythematosus
    Keywords
    Belimumab, Pediatric, Pharmacokinetics, Systemic Lupus Erythematosus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Masking Description
    Click here to enter text.
    Allocation
    N/A
    Enrollment
    14 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Participants receiving belimumab + Standard of care (SOC)
    Arm Type
    Experimental
    Arm Description
    Participants will receive belimumab 200 milligrams SC injection according the Baseline body weight plus SOC.
    Intervention Type
    Biological
    Intervention Name(s)
    Belimumab
    Intervention Description
    Belimumab will be administered
    Intervention Type
    Drug
    Intervention Name(s)
    Standard of care
    Intervention Description
    Standard of care will be administered
    Primary Outcome Measure Information:
    Title
    Area under the curve at steady-state to the end of the dosing period (AUCss, 0-tau) of belimumab
    Time Frame
    Up to Week 12.
    Title
    Average serum concentration at steady state (Cavg, ss) of belimumab
    Time Frame
    Up to Week 12.
    Title
    Minimum serum concentrations at steady state (Cmin, ss) of belimumab
    Time Frame
    Up to Week 12.
    Title
    Maximum serum concentrations during the dosing interval at steady state (Cmax, ss) of belimumab
    Time Frame
    Up to Week 12.
    Secondary Outcome Measure Information:
    Title
    Number of participants with serious adverse events and non-serious adverse events
    Time Frame
    Up to Week 12.
    Title
    Number of participants with adverse events of special interest (AESIs)
    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 between 5 and 17 years of age inclusive, at the time of informed consent Chinese pediatric participants with SLE, who have completed 48 weeks treatment in study 213560 and who, in the opinion of the investigator, may benefit from treatment with GSK1550188. Body weight greater than equal to >=15 kilograms (kg), at the time of signing the informed consent. Male and/or female: No contraceptive measures are required for male participants. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: i) Is a woman of non-childbearing potential OR ii) Is a woman of childbearing potential and using a contraceptive method that is highly effective, with a failure rate of <1% Participant signs and dates a written age-appropriate assent form (in accordance with applicable regulations) and the parent or legal guardian (or emancipated minor) that has the ability to understand the requirements of the study, provides written informed consent (including consent for the use and disclosure of research-related health information) that the participant will comply with the study protocol procedures (including required study visits). Exclusion Criteria: Participants who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an Adverse events (AE) in 213560 study that could, in the opinion of the principal investigator, put the participant at undue risk. Have developed any other medical diseases (e.g., cardiopulmonary), laboratory abnormalities, or conditions that, in the opinion of the principal investigator, makes the participant unsuitable for the study. Have an estimated glomerular filtration rate as calculated by Schwartz Formula of less than 30 milliliter per minute (mL/min). Have an Immunoglobulin A (IgA) deficiency (IgA level <10 milli gram per deciliter [mg/dL]). Have a Grade 3 or greater laboratory abnormality based on the protocol toxicity scale except for the following that are allowed: 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 transaminase (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. Developing a positive test for Human immunodeficiency virus (HIV) antibody after inclusion into 213560, per investigator's discretion according to clinical need. Developing hepatitis B: Serologic evidence of Hepatitis B (HB) infection defined as Hepatitis B surface antigen positive (HBsAg+) OR Hepatitis B core antibody positive (HBcAb+) after inclusion into 213560, per investigator's discretion according to clinical need. Developing a positive test for Hepatitis C antibody after inclusion into 213560, per investigator's discretion according to clinical need. Have received a live or live-attenuated vaccine within 30 Days of Day 1. Are unable or unlikely, in the opinion of the investigator, to administer belimumab by SC injection and have no reliable source to administer the injection.
    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
    GSK Clinical Trials
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
    IPD Sharing Time Frame
    Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
    IPD Sharing Access Criteria
    Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
    IPD Sharing URL
    https://www.gsk.com/en-gb/innovation/trials/data-transparency/

    Learn more about this trial

    A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus

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