Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VX-509 · 5 trials · 2 indications
Measured by clinical laboratory tests
Measured by incidence of treatment-emergent adverse events
| Arm | Type | Description |
|---|---|---|
| Single Arm VX-509 | EXPERIMENTAL | - |
| VX-509 100 mg qd Arm | EXPERIMENTAL | - |
| VX-509 200 mg qd Arm | EXPERIMENTAL | - |
| VX-509 300 mg qd Arm | EXPERIMENTAL | - |
| Placebo Arm | PLACEBO_COMPARATOR | - |
| VX-509 150 mg qd Arm | EXPERIMENTAL | - |
| VX-509 100 mg bid Arm | EXPERIMENTAL | - |
| 25 mg b.i.d. VX-509 | EXPERIMENTAL | - |
| 50 mg b.i.d. VX-509 | EXPERIMENTAL | - |
| 100 mg b.i.d. VX-509 | EXPERIMENTAL | - |
| 150 mg b.i.d. VX-509 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Cohort 1 | EXPERIMENTAL | Prednisone 10 mg tablet on Day 1 and 7; VX-509 200 mg tablets on Days 2 thru 7 |
| Cohort 2 | EXPERIMENTAL | Methylprednisolone 8 mg tablet on Day 1 and 7; VX-509 200 mg tablets on Days 2 thru 7 |
| Name | Type | Description |
|---|---|---|
| VX-509 | DRUG | VX-509 dose may be increased every 8 weeks in a stepwise fashion from 100 to 150 mg and from 150 to 200 mg, as needed (determined by ongoing disease activity by CDAI) |
| VX-509 matching placebo | DRUG | 0 mg oral tablet |
| Placebo | DRUG | tablet, placebo b.i.d. for 12 weeks |
| Prednisone | DRUG | - |
| Methylprednisolone | DRUG | - |
Inclusion Criteria: * Subjects must have completed the assigned study drug treatment phase of a previous VX-509 study (e.g., Study 103). * Subjects must voluntarily sign and date the Study 104 informed consent document. * Subject must be willing and able to comply with the scheduled visits, treatme...
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VX-509 is an oral small molecule drug developed by Vertex Pharmaceuticals for rheumatoid arthritis and drug interaction studies. It is described in trial records as an oral JAK3 inhibitor. It has been studied in Phase 1 and Phase 2 clinical trials, including a 24-week study in patients taking methotrexate.
VX-509 targets JAK3, a Janus kinase enzyme. Trial titles describe VX-509 as an oral JAK3 inhibitor, meaning it is designed to inhibit JAK3 activity. This mechanism was studied in rheumatoid arthritis patients, including a substudy using magnetic resonance imaging and arthroscopic biopsy.
VX-509 is developed by Vertex Pharmaceuticals Incorporated, which trades under the ticker VRTX. The company sponsored the clinical trials of VX-509 in rheumatoid arthritis and drug interaction studies.
VX-509 is an investigational drug that has been studied in Phase 1 and Phase 2 clinical trials. It is not described as approved. The trials include a Phase 1 drug interaction study and Phase 2 studies in rheumatoid arthritis, all of which are completed.
VX-509 has been studied in four completed trials: NCT01886209, a Phase 1 drug interaction study with prednisone or methylprednisolone; NCT01830985, a Phase 2/3 open-label extension in rheumatoid arthritis; NCT01754935, a Phase 2 MRI and biopsy substudy; and NCT01590459, a Phase 2 study in patients taking methotrexate.
VX-509 was studied in rheumatoid arthritis, including patients taking methotrexate. Trials evaluated it in active rheumatoid arthritis, with one study using magnetic resonance imaging and arthroscopic biopsy. All rheumatoid arthritis trials of VX-509 are listed as completed.