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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07568535 | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Remestemcel-L-rknd Added to Ruxolitinib for Grade III-IV Steroid-Refractory Acute Graft-Versus-Host Disease | PHASE3 | NOT YET_RECRUITING | 180 | — | — | Aug 31, 2026 | Jul 1, 2028 | May 5, 2026 | - | — |
The primary clinical endpoint is overall response at Day 28 post-randomization. Overall response is defined as achieving a PR or CR on Day 28 post-randomization without requirement for new intervening systemic immunosuppressive therapies
| Arm | Type | Description |
|---|---|---|
| Remestemcel-L-rknd | EXPERIMENTAL | Remestemcel-L will be administered as intravenous infusions |
| Placebo | PLACEBO_COMPARATOR | PTM will be administered as intravenous infusions |
| Name | Type | Description |
|---|---|---|
| Remestemcel-L-rknd | DRUG | Remestemcel-L is comprised of ex-vivo cultured adult human MSC |
| Placebo | OTHER | Placebo is infusion based to be given at the same points as remestemcel-L-rknd |
Inclusion Criteria: 1. Age 18 years or older at the time of enrollment. 2. Able to take oral medications 3. Have Grade III-IV SR-aGVHD at the time of enrollment, defined as aGVHD resistant to high dose corticosteroids at a dose of ≥ 1 mg/kg/day methylprednisolone (or equivalent), given alone or in ...
| 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 |