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 ...
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Rontalizumab is an investigational small molecule being developed for the treatment of systemic lupus erythematosus (SLE). It is intended for patients with moderately to severely active disease. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Rontalizumab is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with systemic lupus erythematosus.
Rontalizumab is in Phase 2 clinical development. A Phase 2 trial has been completed, which evaluated the drug in patients with moderately to severely active systemic lupus erythematosus. The drug remains investigational and has not received FDA approval.
Rontalizumab has one completed clinical trial, registered as NCT00962832. This Phase 2 study evaluated the efficacy and safety of the drug in 238 patients with moderately to severely active systemic lupus erythematosus. The trial was randomized, double-blind, and placebo-controlled, and was conducted in the United States, Argentina, Colombia, Mexico, Poland, and Russia.
Rontalizumab is a distinct investigational drug with no alternative names listed. It is a small molecule being developed for systemic lupus erythematosus, and it is not known to be identical to any other approved or investigational medication.