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Monoclonal Antibodies
Belimumab for Lupus
Phase 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have or have had in series 4 or more of the 11 ACR criteria for the classification of SLE.
Have documented positive autoantibody test results within the study screening period, defined as an anti-nuclear antibody (ANA) titre >= 1:80 and/or a positive anti-dsDNA (>=30 international units per milliliter [IU/mL]) serum antibody test based on either the study's central laboratory results or the local laboratory results. Only unequivocally positive values as defined in the laboratory's reference range are acceptable; borderline values will not be accepted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre dose on week 1, week 2, week 4, week 8, week 12, week 16, week 24, week 36, week 52, and week 60
Awards & highlights
Study Summary
This trial is studying the effects of belimumab on pediatric patients with lupus.
Who is the study for?
This trial is for children aged 5 to 17 with Systemic Lupus Erythematosus (SLE) who weigh at least 15 kg. They should have active SLE, positive autoantibody test results, and be on a stable treatment regimen for at least 30 days prior to the start of the study. Participants must not be pregnant or breastfeeding and agree to use effective contraception.Check my eligibility
What is being tested?
The trial tests subcutaneous injections of Belimumab in pediatric patients with SLE. It aims to understand how the drug behaves in their bodies (pharmacokinetics), its safety profile, and how it affects disease activity (pharmacodynamics). The study includes an initial 12-week treatment phase followed by an optional 40-week continuation.See study design
What are the potential side effects?
While specific side effects for this pediatric trial are not listed, Belimumab may generally cause infections, infusion reactions like pain or swelling at injection site, allergic reactions including rash or difficulty breathing, nausea, diarrhea and fever.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I meet at least 4 of the criteria for lupus.
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My blood tests show positive for specific autoantibodies.
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My blood tests show positive for specific autoantibodies.
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My lupus is active with a SELENA SLEDAI score of 6 or more.
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I am taking a low dose of steroids, not exceeding 0.5 mg/kg/day.
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I am not currently taking NSAIDs.
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I am not taking anti-malarial medications like hydroxychloroquine.
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I am between 5 and 17 years old.
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I am not currently taking any immune system altering drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre dose on week 1, week 2, week 4, week 8, week 12, week 16, week 24, week 36, week 52, and week 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre dose on week 1, week 2, week 4, week 8, week 12, week 16, week 24, week 36, week 52, and week 60
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Estimated Average Concentration (Cavg) of Belimumab at Steady State
Estimated Maximum Concentration (Cmax) of Belimumab at Steady State
Estimated Minimum Concentration (Cmin) of Belimumab at Steady State
+1 moreSecondary outcome measures
Number of Participants With Adverse Events (AEs)
Number of Participants With Adverse Events of Special Interest (AESIs)
Number of Participants With Serious Adverse Events (SAEs)
+7 moreSide effects data
From 2018 Phase 3 trial • 80 Patients • NCT0211915636%
Nasopharyngitis
18%
Hypokalaemia
9%
Joint injury
9%
Periodontal disease
9%
Gastroenteritis
9%
Cystitis
9%
Vertigo
9%
Ocular discomfort
9%
Lumbar vertebral fracture
9%
Upper respiratory tract infection
9%
Dental caries
9%
Musculoskeletal chest pain
9%
Cough
9%
Otitis externa bacterial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Phase: Treatment Holiday Group - Re-start Phase
Maintenance Phase: Treatment Holiday
Treatment Phase: Long-term Discontinuation Group
Treatment Phase: Treatment Control Group
Treatment Phase: Treatment Holiday Group - Holiday Phase
Maintenance Phase: Treatment Control
Trial Design
1Treatment groups
Experimental Treatment
Group I: Belimumab 200 mgExperimental Treatment1 Intervention
Participants with Systemic Lupus Erythematosus were administered with Belimumab 200 milligram per milliliter (mg/mL) subcutaneous (SC) injection. The dosing frequency was based on body weight. Participants who weigh more than or equal to 50 kilograms were administered every week, who weigh between 30 to less than 50 kg were administered every 10 days and who weigh less than 30 kg were administered every 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belimumab
2013
Completed Phase 4
~1840
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,764 Previous Clinical Trials
8,104,824 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,596 Previous Clinical Trials
6,144,316 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe kidney inflammation that might need treatment in the first 12 weeks of the trial.I am on medication for a long-term infection like TB or herpes.I've needed 3 or more steroid treatments for another condition in the last 3 months.I am taking or have taken Abatacept.I have tested positive for Hepatitis B.My liver enzyme levels are stable and not due to alcohol, uncontrolled diabetes, or viral hepatitis.I meet at least 4 of the criteria for lupus.I am either male or female.I do not have any major health issues unrelated to my lupus that could risk my safety in the study.I have been on a consistent lupus treatment for at least 30 days.I have not been treated with medications targeting B-cells.I am receiving IVIG treatment.I have a health condition that may not make me suitable for this study, according to a doctor.My blood tests show positive for specific autoantibodies.I have a severe lab result that's not on the allowed list.I am taking anakinra for my condition.My blood tests show positive for specific autoantibodies.I have undergone plasmapheresis.I am not pregnant or breastfeeding and either cannot become pregnant or am using effective birth control.I haven't taken any IV or IM antibiotics for infections in the last 60 days.I haven't had certain treatments in the last 90 days.I haven't taken any experimental drugs recently.I am not taking any new immune system altering drugs.I have lupus affecting my brain or nerves and needed treatment for it within the last 2 months.I have stable low white blood cell counts due to lupus.I am currently taking or have taken anti-TNF medication.I am not taking high doses of steroids or receiving them by injection.I tested positive for Hepatitis C antibody but negative for the virus itself.You have been diagnosed with systemic lupus erythematosus (SLE) using the 1997 American College of Rheumatology criteria.My blood clotting time is stable due to my warfarin treatment.I am managing an ongoing infection.I have protein in my urine.I am not currently taking any NSAIDs.I have stable low blood protein levels due to kidney issues from lupus, not because of liver disease or poor nutrition.My blood takes longer to clot due to lupus, not liver disease or medication.My lupus is active with a SELENA SLEDAI score of 6 or more.I have been on a consistent lupus treatment for at least 30 days.You have tried to harm yourself in the past 6 months or are at high risk of hurting yourself, according to the investigator.I am taking a low dose of steroids, not exceeding 0.5 mg/kg/day.I have been treated with belimumab before.I am not currently taking NSAIDs.I have had cancer in the past 5 years.I have not received a live vaccine in the last 30 days.I am not taking anti-malarial medications like hydroxychloroquine.I cannot self-administer the injection and do not have anyone to do it for me.I am between 5 and 17 years old.I haven't started a new lupus treatment in the last 30 days.My kidney function, measured by eGFR, is below 30 mL/min.I have had a major organ or stem cell transplant.I haven't had certain treatments in the last 364 days.I haven't had certain treatments in the last 30 days.I am receiving or have received IV cyclophosphamide.I have been on dialysis or needed it in the last 90 days.I have not taken any experimental drugs.You have a current drug or alcohol addiction or have had an addiction within the past year.You cannot participate in another experimental treatment study at the same time or within 6 months before starting this study. However, you may be allowed to participate in an observation-only study.I am not currently taking any immune system altering drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Belimumab 200 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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