Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rontalizumab · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1 - Placebo intravenously | PLACEBO_COMPARATOR | Participants received placebo intravenously every 4 weeks for 24 weeks. |
| Part 1 - Rontalizumab 750 mg intravenously | EXPERIMENTAL | Participants received rontalizumab 750 mg intravenously every 4 weeks for 24 weeks. |
| Part 2 - Placebo subcutaneously | PLACEBO_COMPARATOR | Participants received placebo subcutaneously every 2 weeks for 24 weeks. |
| Part 2 - Rontalizumab 300 mg subcutaneously | EXPERIMENTAL | Participants received rontalizumab 300 mg subcutaneously every 2 weeks for 24 weeks. |
| Part 3 - Rontalizumab 750 mg intravenously | EXPERIMENTAL | Participants received rontalizumab 750 mg intravenously every 4 weeks for 120 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo was supplied as a sterile liquid solution. |
| Rontalizumab | DRUG | Rontalizumab was supplied as a sterile liquid solution. |
Inclusion Criteria: * Diagnosis of SLE. * Active disease at the time of screening. * Agreement to use an effective form of contraception for the duration of the study. Exclusion Criteria: * Acutely life- or organ-threatening manifestations of systemic lupus erythematosus (SLE) (eg, proliferative ...
Top 20 of 34 competitors
Rontalizumab is an investigational monoclonal antibody that was studied for the treatment of systemic lupus erythematosus (SLE). It was evaluated in patients with moderately to severely active disease. It is not an approved therapy and remains in clinical development, with Phase 2 testing completed.
Rontalizumab targets multiple interferon-alpha subtypes, including IFNA1, IFNA2, IFNA5, IFNA6, IFNA8, and IFNA10. It acts as an inhibitor of these interferon-alpha proteins, which are implicated in the immune dysregulation seen in systemic lupus erythematosus.
Rontalizumab was developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical program evaluating the antibody in systemic lupus erythematosus.
Rontalizumab is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved for any indication.
Rontalizumab was studied in the completed Phase 2 trial NCT00962832, titled a study to evaluate the efficacy and safety of rontalizumab in patients with moderately to severely active systemic lupus erythematosus. The randomized, double-blind, placebo-controlled trial enrolled 238 patients across the United States, Argentina, Colombia, Mexico, Poland, and Russia.
Rontalizumab is a distinct monoclonal antibody that inhibits multiple interferon-alpha subtypes, including IFNA1, IFNA2, IFNA5, IFNA6, IFNA8, and IFNA10. It was developed specifically by Roche for systemic lupus erythematosus and is not interchangeable with other therapies.