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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03818607 | A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH | PHASE3 | COMPLETED | 42 | — | — | Jan 22, 2019 | Jul 12, 2022 | May 23, 2023 | 24 | United States, Czechia +12 |
The primary analysis for the parallel comparison was hemolysis as measured by LDH at Week 27 by initial treatment received (Period 1).
The primary analysis for the crossover comparison was hemolysis, as measured by the time-adjusted AUEC of LDH, according to treatment assigned during each of the 14-week assessments during Periods 1 and 2.
| Arm | Type | Description |
|---|---|---|
| T (ABP 959) / R (eculizumab) | OTHER | ABP 959 for 52 weeks in Period 1 followed by eculizumab for 26 weeks in Period 2 |
| R (eculizumab) / T (ABP 959) | OTHER | Eculizumab for 52 weeks in Period 1 followed by ABP 959 for 26 weeks in Period 2 |
| Name | Type | Description |
|---|---|---|
| ABP 959 | DRUG | intravenous infusion |
| Eculizumab | DRUG | intravenous infusion |
Inclusion Criteria: * Men and women ≥ 18 years of age. * Historical diagnosis of PNH. * Administration of eculizumab for ≥ 6 months and currently receiving 900 mg of eculizumab. * Hemoglobin ≥ 9.0 g/dL for at least 6 weeks before randomization. * Lactate dehydrogenase \< 1.5 × the upper limit of no...