Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INC424 · 2 trials · 2 indications
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant regardless of causal relationship to study drug and regardless whether study drug has been administered. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. A non-serious AE is any AE that does not meet the criteria above.
ORR is defined as the percentage of participants demonstrating a complete response (CR) or partial response (PR) without the requirement of additional systemic therapies for an earlier progression, mixed response or non-response. The response is assessed per National Institute of Health (NIH) consensus criteria and scoring of response was relative to the organ stage at the start of study treatment.
| Arm | Type | Description |
|---|---|---|
| INC424 | EXPERIMENTAL | 5 - 25 mg twice a day (BID) |
| INC424 (ruxolitinib) | EXPERIMENTAL | All pediatric participants received ruxolitinib twice a day (BID) in either tablet or oral solution (liquid), depending on the group they were in. |
| Name | Type | Description |
|---|---|---|
| INC424 | DRUG | All patients enrolled into the study will receive INC424 (ruxolitinib). Starting dose is based on baseline platelet counts, with doses ranging from 5 to 20 mg twice a day. No INC424 dose will exceed 25 mg BID orally. |
Main Inclusion Criteria: 1. Patients must not be eligible for another ongoing INC424 clinical trial. 2. Patients must be diagnosed with PMF, PPV MF or PET-MF, according to the 2008 revised International Standard Criteria, irrespective of JAK2 mutation status.. 3. Patients with PMF requiring therapy...
INC424 is an investigational small molecule being studied for the treatment of myelofibrosis and graft versus host disease. It is being developed by Novartis AG. The drug has been evaluated in clinical trials for these conditions, including a completed Phase 3 study in myelofibrosis and a completed Phase 2 study in chronic graft versus host disease.
INC424 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of INC424 in patients with myelofibrosis and graft versus host disease.
INC424 is in clinical development, with completed trials including a Phase 3 study in myelofibrosis and a Phase 2 study in graft versus host disease. The drug is not approved and remains investigational. Novartis has completed these trials, and the drug's development status is based on the available clinical trial data.
INC424 has been studied in clinical trials registered under NCT01493414 and NCT03774082. NCT01493414 was a Phase 3 study in patients with primary myelofibrosis, post polycythemia myelofibrosis, or post-essential thrombocythemia myelofibrosis, enrolling 2233 participants. NCT03774082 was a Phase 2 study in pediatric subjects with moderate and severe chronic graft versus host disease, enrolling 46 participants.
INC424 is the development code for the drug also known as ruxolitinib, a Janus kinase inhibitor. In clinical trials, INC424 has been evaluated for myelofibrosis and graft versus host disease. The drug is being developed by Novartis AG under this code name.