Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01639339 | Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis | PHASE3 | COMPLETED | 448 | — | — | Jul 12, 2012 | Mar 12, 2020 | Mar 19, 2021 | 118 | United States, Argentina +19 |
PERR is defined as urinary protein creatinine ratio \<=0.7, estimated glomerular filtration rate (eGRF) was not more than 20 percent (%) below the pre-flare value or \>=60 milliliters per minute per 1.73 square meter (mL/min/1.73m\^2) and was not a treatment failure. Analysis was performed using a logistic regression model for the comparison between Belimumab and Placebo with covariates treatment group, induction regimen (CYC vs. MMF), race (Black vs. Non-Black), Baseline urine protein-creatinine ratio (uPCR), and Baseline eGFR. Modified Intent-to-treat (mITT) Population consisted of all randomized participants who received at least one dose of study treatment and were not excluded due to Good Clinical Practice (GCP) non-compliance. Percentage of participants with PERR at Week 104 has been presented.
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported.
An AESI is one of scientific and medical concern specific to the product, for which ongoing monitoring and rapid communication by investigator to sponsor can be appropriate. A summary of protocol defined AESIs include malignant neoplasms including and excluding non-melanoma skin cancer (NMSC), post-infusion systemic reactions (PISR), all infections of special interest (opportunistic infections \[OI\], Herpes Zoster \[HZ\], tuberculosis \[TB\], and sepsis), depression (including mood disorders and anxiety)/suicide/self-injury and deaths.
| Arm | Type | Description |
|---|---|---|
| Placebo plus standard therapy | PLACEBO_COMPARATOR | Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and then every 28 days thereafter through Week 100, with a final evaluation at Week 104 in the double-blind period. In the open-label extension period, placebo patients who opt to participate will receive belimumab 10 mg/kg IV every 28 days for an additional 6 months. |
| Belimumab 10 mg/kg plus standard therapy | EXPERIMENTAL | Belimumab 10 mg/kg IV plus standard therapy; belimumab administered on Days 0, 14, 28, and then every 28 days thereafter through Week 100, with a final evaluation at Week 104 in the double-blind period. In the open-label extension period, patients who opt to participate will continue to receive belimumab 10 mg/kg IV every 28 days for an additional 6 months. |
| Name | Type | Description |
|---|---|---|
| Placebo plus standard therapy | BIOLOGICAL | Placebo plus standard therapy |
| Belimumab 10 mg/kg plus standard therapy | BIOLOGICAL | Belimumab 10 mg/kg plus standard therapy |
| Standard therapy | DRUG | The standard therapies allowed in this study are: \- High-dose steroids (for example, methylprednisolone) plus cyclophosphamide for induction therapy followed by azathioprine for maintenance therapy OR \- High-dose steroids plus mycophenolate for induction therapy followed by mycophenolate for maintenance therapy |
Key Inclusion Criteria: * Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria. * Biopsy confirmed active lupus nephritis. * Clinically active lupus renal disease at screening requiring /receiving induction therapy with Standard of Care medications. * Autoantibody-positive. ...