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 Exclusion Criteria: * MS relapse during the 6 months preceding the randomization date * Lack of peripheral venous access * History ...
RO7268489 is an investigational small molecule being studied as an add-on therapy to ocrelizumab in participants with progressive forms of multiple sclerosis (MS). It is currently in Phase 2 clinical development for this indication, and it is not yet approved by regulatory authorities.
RO7268489 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 2 clinical trial to evaluate the drug as an add-on therapy to ocrelizumab in patients with progressive multiple sclerosis.
RO7268489 is in Phase 2 clinical development. It is an investigational drug being studied for progressive multiple sclerosis, and it has not been approved by the FDA or any other regulatory agency. The ongoing Phase 2 trial is currently recruiting participants.
RO7268489 is being evaluated in one active Phase 2 clinical trial, NCT07282574. This randomized, double-blind, placebo-controlled study is assessing the safety, pharmacokinetics, pharmacodynamics, and efficacy of RO7268489 as add-on therapy to ocrelizumab in participants with progressive multiple sclerosis. The trial plans to enroll 360 participants.
No, RO7268489 is not the same as ocrelizumab. RO7268489 is an investigational small molecule being studied as an add-on therapy to ocrelizumab in patients with progressive multiple sclerosis. Ocrelizumab is an existing treatment, and the trial is evaluating whether adding RO7268489 provides additional benefit.