Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03139604 | GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease | PHASE3 | COMPLETED | 439 | — | — | Jul 19, 2017 | Jul 13, 2020 | Sep 2, 2025 | 129 | United States, Australia +17 |
| NCT02614612 | Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD | PHASE1 | COMPLETED | 31 | — | — | Dec 1, 2015 | Aug 1, 2018 | Mar 8, 2019 | 23 | United States |
Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).
| Arm | Type | Description |
|---|---|---|
| Itacitinib | EXPERIMENTAL | Itacitinib plus corticosteroids |
| Placebo | PLACEBO_COMPARATOR | Matching placebo plus corticosteroids |
| Itacitinib (200 mg) | EXPERIMENTAL | Itacitinib (200 mg) + prednisone or methylprednisolone (corticosteroids) |
| Itacitinib (300 mg) | EXPERIMENTAL | Itacitinib (300 mg) + prednisone or methylprednisolone (corticosteroids) |
| Name | Type | Description |
|---|---|---|
| Itacitinib | DRUG | Itacitinib at the protocol-defined dose administered orally once daily (QD) plus corticosteroids. |
| Placebo | DRUG | Matching placebo tablets administered orally once daily (QD) plus corticosteroids. |
| Prednisone | DRUG | Oral prednisone may be used to begin standard corticosteroid background treatment at the investigator's discretion, at a dose equivalent to methylprednisolone 2 mg/kg per day. |
| Methylprednisolone | DRUG | Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose appropriate for the severity of disease as background treatment. |
| Itacitinib (200 mg) | DRUG | - |
| Itacitinib (300 mg) | DRUG | - |
| prednisone or methylprednisolone (corticosteroids) | DRUG | All subjects will receive prednisone 2.5 mg/kg per day PO (or methylprednisolone 2 mg/kg IV daily) on Days 1 through 5. Subjects will be tapered as tolerated beginning on Day 6 to no less than 0.25 mg/kg per day PO (or methylprednisolone 0.2 mg/kg per day) by Day 28. After Day 28, corticosteroids should be tapered according to institutional guidelines to attain ≤ prednisone 0.2 mg/kg per day (or ≤ methylprednisolone 0.16 mg/kg per day) by Day 56. |
Inclusion Criteria: * Has undergone 1 allo-HSCT from any donor (related or unrelated with any degree of HLA matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder. Recipients of myeloablative and reduced-intensity conditioni...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 11 | PHASE3 | INCA034176, Tacrolimus, Methotrexate, Ruxolitinib, Cyclophosphamide |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | Belumosudil, Prednisone, Prednisolone |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Ibrutinib |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Theriva Biologics, Inc. | TOVX | 1 | PHASE1 | Undisclosed |
| Novartis AG Sponsored ADR | NVS | 1 | — | Undisclosed |