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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

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 below
Select...
My lupus is active, or I'm on high-dose steroids for it.
Select...
I was diagnosed with lupus according to ACR criteria within the last 2 years.
Select...
I am not able to have children or I am using effective birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and up to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and up to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52
Secondary outcome measures
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 more

Side effects data

From 2017 Phase 3 trial • 106 Patients • NCT01663623
19%
Cough
13%
Upper respiratory tract infection
13%
Nausea
13%
Fatigue
11%
Nasopharyngitis
11%
Arthralgia
11%
Pyrexia
9%
Influenza
9%
Diarrhoea
9%
Vomiting
9%
Headache
9%
Rash
9%
Urinary tract infection
9%
Epistaxis
8%
Oropharyngeal pain
6%
Abdominal pain upper
6%
Back pain
6%
Hypertension
4%
Hypersensitivity
4%
Bursitis
2%
Ischaemic stroke
2%
Haemorrhagic stroke
2%
Neutropenic sepsis
2%
Lower respiratory tract infection
2%
Cellulitis
2%
Hip fracture
2%
Pneumothorax traumatic
2%
Post procedural discharge
2%
General physical health deterioration
2%
Basal cell carcinoma
2%
Plasma cell myeloma
2%
Chronic gastritis
2%
Cholangitis
2%
Hypercalcaemia
2%
Acute kidney injury
2%
Abdominal pain
2%
Neutropenia
2%
Thrombocytopenia
2%
Anaphylactic reaction
2%
Anal cancer
2%
Pneumomediastinum
2%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Belimumab 10 mg/kg

Trial Design

1Treatment groups
Experimental Treatment
Group I: Belimumab (GSK1550188)Experimental Treatment1 Intervention
Participants will receive GSK1550188.

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,788 Previous Clinical Trials
8,176,455 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,601 Previous Clinical Trials
6,144,662 Total Patients Enrolled
~233 spots leftby Apr 2027
Unbiased ResultsWe believe in providing patients with all the options.
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