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Monoclonal Antibodies
Belimumab for Lupus (BE-EARLY Trial)
Phase 4
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical SLEDAI-2K (excluding anti-dsDNA and C3/C4) score greater than (>) 4, OR Clinical SLEDAI-2K (excluding anti-dsDNA and C3/C4) ≤4 and prednisone or equivalent dose ≥10 milligram per day (mg/day)
Documented clinical diagnosis of SLE within 2 years of signing the informed consent according to the American College of Rheumatology (ACR) SLE classification criteria 2019
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and up to week 52
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
"This trial will study the effectiveness and safety of belimumab over a period of 3 years in patients with early lupus who have ongoing symptoms despite being on standard treatment."
Who is the study for?
This trial is for adults with early-stage Systemic Lupus Erythematosus (SLE) who have ongoing symptoms despite treatment. Participants must meet certain criteria, including a specific SLE disease activity score or be on a stable dose of steroids. Women capable of having children must use effective contraception, and all participants should have been diagnosed within the last two years.
What is being tested?
The study is testing the safety and effectiveness of Belimumab in treating SLE over three years. It's an open-label trial, meaning both researchers and participants know what treatment is being given, focusing on those who've recently been diagnosed and are still experiencing active symptoms.
What are the potential side effects?
While not specified here, common side effects of Belimumab may include nausea, diarrhea, fever, stuffy or runny nose, coughing; some people might experience infusion reactions or infections due to its impact on the immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lupus is active, or I'm on high-dose steroids for it.
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I was diagnosed with lupus according to ACR criteria within the last 2 years.
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I am not able to have children or I am using effective birth control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 and up to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and up to week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part A: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52
Secondary study objectives
Part A: Estimate of Probability of Having a Severe Flare Defined as Modified SELENA-SLEDAI Flare Index (SFI) at Week 52
Part A: Percentage of Participants Achieving Average Oral Prednisone Equivalent Dose ≤ 5 mg/day at Week 52
Part A: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) for ≥ 25 percent (%) of time from Day 1 to Week 52
+1 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Belimumab (GSK1550188)Experimental Treatment1 Intervention
Participants will receive GSK1550188.
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Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,383,840 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,609 Previous Clinical Trials
6,145,209 Total Patients Enrolled