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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01273389 | An Efficacy and Safety Study of CNTO 136 in Patients With Active Lupus Nephritis | PHASE2 | COMPLETED | 25 | — | — | Aug 1, 2011 | Sep 1, 2013 | Mar 24, 2016 | 21 | United States, Belgium +4 |
It is measured as the percentage in reduction of proteinuria from baseline to Week 24.
| Arm | Type | Description |
|---|---|---|
| CNTO 136 | EXPERIMENTAL | CNTO 136 is used in the form of final vialed product, as a single-use, sterile solution in a 2 ml glass vial. Each 1 mL of the solution contains sirukumab 100mg active drug substance, sorbitol, acetate buffer, and polysorbate 20, at a pH of 5.0, without any preservatives. |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CNTO 136 | DRUG | Type=exact number, unit=mg/kg, number=10, form=solution for injection, route=intravenous. CNTO 136 is administered once every 4 weeks from Week 0 to Week 24. |
| Placebo | DRUG | Form=solution for injection, route=intravenous. Placebo is administered once every 4 weeks from Week 0 to Week 24. |
Inclusion Criteria: * Diagnosis of Systemic lupus erythematosus (SLE), and biopsy-proven International Society of Nephrology/Renal Pathology Society Class III or IV lupus glomerulonephritis within approximately 14 months prior to randomization * Persistently active nephritis defined as, proteinuria...