Clinical trial NCT05917288: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Keywords: Belimumab
Pediatric
Pharmacokinetics
Systemic Lupus Erythematosus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2023-06-23
Enrollment: 16
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 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)


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:

  1. No contraceptive measures are required for male participants.
  2. 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:

  1. Stable Grade 3 hypoalbuminemia due to lupus nephritis and not related to liver disease or malnutrition.
  2. Any grade proteinuria
  3. 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.
  4. 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.

Primary outcomes:
measure: Area under the curve at steady-state to the end of the dosing period (AUCss, 0-tau) of belimumab
timeFrame: Up to Week 12.
measure: Average serum concentration at steady state (Cavg, ss) of belimumab
timeFrame: Up to Week 12.
measure: Minimum serum concentrations at steady state (Cmin, ss) of belimumab
timeFrame: Up to Week 12.
measure: Maximum serum concentrations during the dosing interval at steady state (Cmax, ss) of belimumab
timeFrame: Up to Week 12.
Secondary outcomes:
measure: Number of participants with serious adverse events and non-serious adverse events
timeFrame: Up to Week 12.
measure: Number of participants with adverse events of special interest (AESIs)
timeFrame: Up to Week 12.
Other outcomes:
Locations:
city: Beijing
country: China
facility: GSK Investigational Site
city: Changsha
country: China
facility: GSK Investigational Site
city: Hangzhou
country: China
facility: GSK Investigational Site
city: Nanjing
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Suzhou
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GSK Clinical Trials
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: