Phase 2
N=298
A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT00583362 ↗Enrolled (actual)
298
Serious AEs
61.5%
Results posted
Apr 2017
Primary outcome: Primary: Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) — 294; 291; 283; 260 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Belimumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Human Genome Sciences Inc., a GSK Company
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) |
294; 291; 283; 260; 239; 203 | — |
| PRIMARY Adverse Event (AE) Rates by System Organ Class (SOC) During the Study |
285; 276; 257; 256; 247; 244 | — |
| PRIMARY SAE Rates by System Organ Class (SOC) During the Study |
69; 44; 38; 35; 31; 29 | — |
| PRIMARY Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points |
0.3; -1.3; -1.6; -1.9; -1.6; -1.0 | — |
| PRIMARY Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points |
0.001; 0.000; 0.000; 0.002; 0.001; 0.001 | — |
| PRIMARY Change From Baseline in Erythrocytes at the Indicated Time Points |
0.01; 0.04; 0.05; 0.07; 0.10; 0.11 | — |
| PRIMARY Change From Baseline in Hematocrit at the Indicated Time Points |
0.11; 0.23; 0.28; 0.44; 0.60; 0.84 | — |
| PRIMARY Change From Baseline in Hemoglobin at the Indicated Time Points |
0.1; 0.6; 1.5; 2.2; 2.8; 2.9 | — |
| PRIMARY Change From Baseline in Albumin and Protein at the Indicated Time Points |
0.1; -0.2; 0.2; 0.1; 0.2; 0.3 | — |
| PRIMARY Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points |
0.0189; -0.0836; -0.0281; -0.0199; -0.1823; 0.0224 | — |
| PRIMARY Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points |
0.436; 0.464; 1.211; 1.047; 0.965; 0.955 | — |
| PRIMARY Change From Baseline in BUN/Creatinine at the Indicated Time Points |
-0.1; -0.4; -0.4; -0.4; -0.8; -0.3 | — |
| PRIMARY Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points |
-0.7; 0.2; 0.9; -0.6; -0.6; -1.3 | — |
| SECONDARY Percentage of Participants Achieving SLE Responder Index (SRI) Response at Indicated Time Points |
32.8; 41.6; 47.0; 50.8; 56.5; 57.0 | — |
| SECONDARY Observed Anti-double Stranded DNA Levels in Participants Positive at Baseline at Indicated Time Points |
147.00; 114.00; 113.00; 106.50; 93.50; 85.00 | — |
| SECONDARY Median Percent Change From Baseline in Anti-double Stranded DNA in Participants Positive at Baseline at Indicated Time Points |
-16.26; -25.57; -30.17; -30.26; -31.25; -41.63 | — |
| SECONDARY Observed Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points |
0.77; 0.81; 0.81; 0.82; 0.82; 0.84 | — |
| SECONDARY Median Percent Change From Baseline in Complement C3 and C4 Levels in Participants Low at Baseline at Indicated Time Points |
8.87; 8.43; 11.71; 13.10; 13.21; 17.16 | — |
| SECONDARY Percentage of Participants With Daily Prednisone Dose Reduction at Indicated Time Points |
0; 5.6; 19.8; 19.8; 23.0; 27.3 | — |
| SECONDARY Absolute Serum Immunoglobulin G Values at Indicated Time Points |
12.90; 12.10; 11.70; 11.60; 11.50; 11.40 | — |
| SECONDARY Median Percent Change From Baseline in Immunoglobulin G at Indicated Time Points |
-6.09; -7.69; -8.78; -8.84; -10.32; -9.34 | — |
Summary
This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.
Eligibility Criteria
Primary Inclusion Criteria
- Have completed the LBSL02 trial and achieved a satisfactory response.
Primary Exclusion Criteria
- Required more than 2 courses of corticosteroids for treatment of severe SLE flares in the last 5 months of LBSL02.
- Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99.
- Used any of the following prohibited medications during their participation in LBSL02:
- Other investigational agents.
- Biologic therapeutic agents: adalimumab (Humira™), etanercept (Enbrel™), infliximab (Remicade™), and rituximab (Rituxan™).
- Intravenous cyclophosphamide.
- Corticosteroids >100 mg/day prednisone equivalent for reasons other than severe SLE flare.
Data sourced from ClinicalTrials.gov (NCT00583362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.