Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO7268489 · 1 trial · 1 indication
Time from randomization to the first occurrence of cCDP12 according to at least one of the following 3 criteria: 1. 12-week confirmed disability progression (CDP12) 2. 12-week confirmed increase in Timed 25-Foot Walk Test (T25FWT) or 3. 12-week confirmed increase in 9-Hole Peg Test (9-HPT) The EDSS is a disability scale is based on a standard neurological examination that ranges in 0.5-point steps from 0 (normal) - 10 (death). T25FWT=time taken to walk 25 feet, typically measured in seconds. The longer it takes to walk, the higher score, which indicates deterioration. Lower times indicate better performance and greater mobility. In 9-HPT, participants are instructed to place pegs one by one into each of nine holes arranged in a board stabilized with a plastic nonslip sheet on a solid table, and then to remove these pegs from the holes. The shorter time it takes to complete the task indicates a better outcome.
| Arm | Type | Description |
|---|---|---|
| RO7268489 Dose 1 + Ocrelizumab | EXPERIMENTAL | Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen. |
| RO7268489 Dose 2 + Ocrelizumab | EXPERIMENTAL | Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen. |
| RO7268489 Dose 3 + Ocrelizumab | EXPERIMENTAL | Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen. |
| Placebo + Ocrelizumab | PLACEBO_COMPARATOR | Participants will receive RO7268489 matching placebo along with ocrelizumab as per the pre-defined regimen. |
| Name | Type | Description |
|---|---|---|
| RO7268489 | DRUG | RO7268489 will be administered per schedule as specified in the arms. |
| Ocrelizumab | DRUG | Ocrelizumab will be administered per schedule as specified in the arms. |
| Placebo | DRUG | Placebo will be administered per schedule as specified in the arms. |
Inclusion Criteria: * PMS, in accordance with the revised 2017 McDonald criteria * Expanded disability status scale (EDSS) at screening between 3.0 and 6.0 inclusive * Documented evidence of disability progression independent of relapse activity over the 2 years before the screening visit Exclusio...
RO7268489 is an investigational small molecule drug being developed by Roche Holding AG for progressive forms of multiple sclerosis. It is currently in Phase 2 clinical development and is designed to be given as add-on therapy to ocrelizumab in participants with progressive MS.
RO7268489 is being studied as an add-on therapy to ocrelizumab in participants with progressive forms of multiple sclerosis. The Phase 2 trial evaluates its safety, pharmacokinetics, pharmacodynamics, and efficacy in adults aged 18 years and older with progressive MS.
RO7268489 is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is running the clinical program for the drug in progressive forms of multiple sclerosis as an add-on to ocrelizumab.
RO7268489 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The ongoing Phase 2 study is currently recruiting participants and is designed to assess safety, pharmacokinetics, pharmacodynamics, and efficacy in progressive forms of multiple sclerosis.
RO7268489 is being studied in one active clinical trial, NCT07282574, titled a study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of RO7268489 as add-on therapy to ocrelizumab in participants with progressive forms of multiple sclerosis. The trial is recruiting, randomized, double-blind, placebo-controlled, and plans to enroll 360 participants across multiple countries.