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Also known as Belimumab
Belimumab/kg · 1 trial · 1 indication
Time to relapse is defined as the number of days from Day 0 until the participant experienced a relapse (relapse date - treatment start date +1). Only post-baseline relapses were considered in these analyses. Only relapses occurring up to and including the last visit date in the double-blind treatment period were considered in these analyses. Intent-to-treat population comprised of all randomized participants who received at least one dose of study agent (belimumab or placebo). NA indicates that the data was not available as the Number of events is too low to estimate the value. Median and Inter-quartile range were presented and were based on Kaplan Meier estimates.
| Arm | Type | Description |
|---|---|---|
| Placebo plus azathioprine | PLACEBO_COMPARATOR | Placebo IV plus oral azathioprine 2 mg/kg/day; placebo administered on Days 0, 14, 28, and then every 28 days until the end of the study. If the results in the double-blind period show that belimumab is safe and effective, then participants have the option to receive treatment with belimumab in a 6-month open-label extension phase. Placebo patients who opt to participate in the extension will receive belimumab 10 mg/kg IV every 28 days plus oral azathioprine 2 mg/kg/day for an additional 6 months. |
| Belimumab 10 mg/kg plus azathioprine | EXPERIMENTAL | Belimumab 10 mg/kg IV plus oral azathioprine 2 mg/kg/day; belimumab administered on Days 0, 14, 28, and then every 28 days until the end of the study. If the results in the double-blind period show that belimumab is safe and effective, then participants have the option to continue treatment with belimumab in a 6-month open-label extension phase. Patients who opt to participate in the extension will continue to receive belimumab 10 mg/kg IV every 28 plus oral azathioprine 2 mg/kg/day days for an additional 6 months. |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | Placebo |
| Belimumab 10 mg/kg | BIOLOGICAL | Belimumab 10 mg/kg |
| Azathioprine | DRUG | Azathioprine |
Key Inclusion Criteria: * Clinical diagnosis Wegener's granulomatosis or microscopic polyangiitis by Chapel Hill criteria. * Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids and 1 of the following medications: rituximab, oral cyclophosphamide OR IV cyclophospham...
Belimumab is an investigational antibody being studied for multiple immune-related conditions, including Myasthenia Gravis, Glomerulonephritis, Membranous, Vasculitis, Sjogren's Syndrome, Organ Transplantation, Lupus Nephritis, and interstitial lung disease associated with systemic sclerosis or other connective tissue diseases. It is in Phase 3 clinical development for some of these indications.
Belimumab is a monoclonal antibody (a -mab) that targets and inhibits B-lymphocyte stimulator (BLyS), a protein that promotes the survival of B cells. By blocking BLyS, Belimumab reduces the activity of B cells, which are involved in autoimmune responses. This mechanism is being evaluated in conditions like lupus nephritis and myasthenia gravis.
Belimumab is developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. GSK is conducting clinical trials of Belimumab across multiple countries, including the United States, Canada, Germany, Italy, and others.
Belimumab is in Phase 3 clinical development for interstitial lung disease associated with connective tissue diseases, and it has also been studied in Phase 2 trials for myasthenia gravis and systemic sclerosis. It is an investigational drug and has not been approved for these indications.
Belimumab is being studied in several ongoing trials, including NCT06572384, a Phase 3 study in adults with interstitial lung disease associated with connective tissue disease, and NCT06716606, a long-term safety extension study. A Phase 2 trial, NCT05878717, is recruiting patients with systemic sclerosis-associated interstitial lung disease.
Belimumab is the generic name for the drug also known as Benlysta. While Benlysta is approved for lupus, Belimumab is being investigated in additional conditions such as myasthenia gravis, vasculitis, and interstitial lung disease. The clinical trials listed under the name Belimumab are evaluating these new potential uses.