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NCT04179032 · ClinicalTrials.gov registry record · Phase 2

Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)

A Phase 2 study of Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline.

Active
Registry status
Phase 2
Development phase
25
Enrollment target
11
Study locations

NCT04179032 is a Phase 2 study of Systemic Lupus Erythematosus that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 25 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (93% lower). The trial reports 11 study locations across 2 states.

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The verdict

NCT04179032, a Phase 2 study of Systemic Lupus Erythematosus, is active but no longer recruiting, sponsored by GlaxoSmithKline.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
25 participants
Enrollment target
11
Study locations

Study Summary

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and pharmacodynamics (PD) of repeat doses of 200 milligrams per milliliter (mg/mL) belimumab administered via SC injection in pediatric participants 5 to 17 years of age with SLE on a background of standard of care therapy. This bridging PK study is part of an extrapolation strategy to support the use of SC belimumab in pediatric SLE participants, based on the completed adult SLE study with SC belimumab and the pediatric SLE study with intravenous (IV) belimumab. Part A is an open label 12-week treatment phase where participants will be enrolled and allocated to treatment cohorts based on their body weight at baseline. The dose and dosing regimens selected for SC administration in this pediatric population are intended to achieve a similar average exposure as observed with the weekly 200 mg SC dosing regimen in adult SLE patients. Part B is an optional 40-week open-label continuation phase, open to all participants who have completed Part A. Dosing of SC belimumab may continue at the same frequency in Part B or may require a change in frequency according to changes in participant body weight. The total duration of the study will be 68 weeks including a 12-Week open label treatment phase (Part A), an optional 40-week open-label continuation phase (Part B) and 16-week follow-up.

Conditions Studied

Systemic Lupus Erythematosus

Interventions

  • COMBINATION_PRODUCT Belimumab

Study Locations (11)

Other

  • GSK Investigational Site - Rosario
  • GSK Investigational Site - Berlin
  • GSK Investigational Site - Saint Augustin
  • GSK Investigational Site - Kagoshima
  • GSK Investigational Site - Kanagawa
  • GSK Investigational Site - San Luis Potosí City
  • GSK Investigational Site - Rotterdam
  • GSK Investigational Site - Barcelona
  • GSK Investigational Site - Madrid
  • GSK Investigational Site - Valencia

Ohio

  • GSK Investigational Site - Cincinnati

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2019-11-28
Est. Completion 2027-04-26
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT04179032

The ClinicalTrials.gov registry entry for NCT04179032 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (93% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 1 intervention - of which Belimumab is the first listed.

NCT04179032 reports 11 study locations spanning 2 distinct geographic areas - top geographies include Other, Ohio.

Frequently Asked Questions

What is clinical trial NCT04179032 about?

NCT04179032 is a clinical study titled "Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)". The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and pharmacodynamics (PD) of repeat doses of 200 milligrams per milliliter (mg/mL) belimumab administered via SC injection in pediatric participants 5 to 17 years of age with SLE on a background of standard of care therapy. ...

What is the current status of trial NCT04179032?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2019-11-28. Estimated completion is 2027-04-26.

What conditions does trial NCT04179032 study?

This clinical trial studies the following conditions: Systemic Lupus Erythematosus.

What interventions are being tested in trial NCT04179032?

The interventions under investigation include: Belimumab (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT04179032?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04179032 being conducted?

This trial has 11 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.