Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CNTO 136 · 1 trial · 1 indication
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...
CNTO 136 is an investigational small molecule being studied for the treatment of lupus nephritis, a serious complication of systemic lupus erythematosus that affects the kidneys. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
CNTO 136 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
CNTO 136 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to determine its safety and effectiveness for treating lupus nephritis.
CNTO 136 has been studied in one completed Phase 2 clinical trial with the identifier NCT01273389, titled "An Efficacy and Safety Study of CNTO 136 in Patients With Active Lupus Nephritis." The trial enrolled 25 participants and was conducted in the United States, Belgium, Mexico, Netherlands, Poland, and Thailand.
No, CNTO 136 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for lupus nephritis. The drug has not completed the clinical trial process required for regulatory approval, and its safety and efficacy have not been established.