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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04717414 | An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions | PHASE3 | ACTIVE NOT_RECRUITING | 313 | — | — | Feb 25, 2021 | Aug 18, 2032 | Jul 10, 2025 | 185 | United States, Argentina +24 |
Proportion of subjects who become RBC-transfusion free over any consecutive 12-week period starting within the first 24 weeks.
| Arm | Type | Description |
|---|---|---|
| Experimental Arm: Luspatercept (ACE-536) | EXPERIMENTAL | Luspatercept will be given to participants via subcutaneous injection (administered on Day 1 of each 21-day treatment cycle) |
| Control Arm: Placebo | PLACEBO_COMPARATOR | Placebo starting dose with volume equivalent to experimental arm subcutaneous injection every 3 weeks (administered on Day 1 of each 21-day treatment cycle) |
| Name | Type | Description |
|---|---|---|
| ACE-536 | DRUG | Subcutaneous Injection |
| Placebo | OTHER | Subcutaneous Injection |
Subjects must satisfy the following criteria to be randomized in the study: Inclusion Criteria \- Subject is ≥18 years of age at the time of signing the ICF. * Subject has a diagnosis of PMF according to the 2016 World Health Organization (WHO) criteria or diagnosis of post-ET or post-PV MF accor...