Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ruxolitinib · 1 trial · 1 indication
Determined by an Independent Review Committee (IRC) Using International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Revised Response Criteria
| Arm | Type | Description |
|---|---|---|
| Placebo + Ruxolitinib | ACTIVE_COMPARATOR | Participants will receive placebo (PO QD) in combination with ruxolitinib (dose will depend on the participant's baseline platelet count) for up to 48 weeks. |
| Vismodegib + Ruxolitinib | EXPERIMENTAL | Participants will receive vismodegib (150 mg PO QD) in combination with ruxolitinib (dose will depend on the participant's baseline platelet count) for up to 48 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Placebo will be administered PO QD for up to 48 weeks. |
| Ruxolitinib | DRUG | Ruxolitinib will be administered PO BID at a starting dose depending on the participants's baseline platelet count for up to 48 weeks. |
| Vismodegib | DRUG | Vismodegib will be administered at a dose of 150 mg PO QD for up to 48 weeks. |
Inclusion Criteria: * Pathologically confirmed diagnosis of primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF, according to the 2008 revised World Health Organization criteria * Intermediate-1, intermediate-2, or high-risk according to the IWG-MRT Dynamic International Pro...
Ruxolitinib is an investigational small molecule being studied for the treatment of intermediate- or high-risk myelofibrosis. It is currently in Phase 1 clinical development. The drug is being evaluated in combination with vismodegib in a completed clinical trial.
Ruxolitinib is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on the drug for the treatment of myelofibrosis, a type of bone marrow cancer.
Ruxolitinib is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial evaluating the drug in combination with vismodegib for myelofibrosis has been completed.
Ruxolitinib has been studied in one clinical trial, identified as NCT02593760. This Phase 1 study evaluated the efficacy and safety of vismodegib in combination with ruxolitinib for intermediate- or high-risk myelofibrosis. The trial enrolled 10 participants and has been completed.
Ruxolitinib is a distinct drug candidate developed by Roche Holding AG. No alternative names for this drug have been disclosed in the available information. It is being studied specifically for the treatment of myelofibrosis.