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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04617028 | Jaktinib Versus Hydroxycarbamide in Subjects With Intermediate-2 or High-risk Myelofibrosis | PHASE3 | COMPLETED | 105 | — | — | Feb 5, 2021 | Oct 18, 2023 | Nov 13, 2023 | 1 | China |
Splenic response rate at Week 24 is defined as the proportion of participants achieving a ≥ 35% reduction in spleen volume at Week 24 from baseline as measured by MRI or CT
| Arm | Type | Description |
|---|---|---|
| Jaktinib | EXPERIMENTAL | Participants will receive Jaktinib plus placebo to match Hydroxycarbamide. |
| Hydroxycarbamide | ACTIVE_COMPARATOR | Participants will receive Hydroxycarbamide plus placebo to match Jaktinib. |
| Name | Type | Description |
|---|---|---|
| Jaktinib | DRUG | Jaktinib Hydrochloride Tablets administered orally twice daily |
| Placebo to match Hydroxycarbamide | DRUG | Placebo to match Hydroxycarbamide Tablets administered orally twice daily |
| Hydroxycarbamide Tablets | DRUG | Hydroxycarbamide Tablets administered orally twice daily |
| Placebo to match Jaktinib | DRUG | Placebo to match Jaktinib Tablets administered orally twice daily |
Inclusion Criteria: * Age ≥ 18 years old,either male or female; * Subjects diagnosed with a PMF according to World Health Organiztion criteria (2016 Edition), or patients diagnosed with a Post-PV-MF or Post-EF-MF according to International Working Group for Myeloproliferative Neoplasms Research and...