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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04138927 | A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia | PHASE3 | ENROLLING BY_INVITATION | 90 | — | — | Oct 30, 2019 | Apr 1, 2024 | Mar 17, 2022 | 37 | United States, Australia +16 |
| NCT03764618 | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA | PHASE3 | COMPLETED | 90 | — | — | Apr 24, 2019 | Apr 11, 2022 | May 25, 2023 | 102 | United States, Australia +20 |
Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study
Change from baseline in blood pressure over time
Change from baseline in absolute neutrophil count (ANC) over time
Proportion of subjects achieving a hemoglobin level ≥ 10 g/dL with an increase from Baseline in hemoglobin level of ≥ 2 g/dL on 3 consecutive available visits during the 24-week treatment period.
| Arm | Type | Description |
|---|---|---|
| Fostamatinib | EXPERIMENTAL | Subjects who at any time during the C-935788-057 study achieved a hemoglobin response will continue at their dose and regimen from the Week 22 visit in the C-935788-057 study. All other subjects who enter the extension study will initially receive fostamatinib 100 mg PO bid. Starting at Week 4, the initial fostamatinib dose of 100 mg PO bid will be increased to fostamatinib 150 mg PO bid if subjects have adequately tolerated the study drug, based on the Investigator's judgment. |
| Placebo | PLACEBO_COMPARATOR | Initial dose is 100 mg by mouth (PO) twice a day (bid). At week 4 dose will be increased to placebo 150 mg PO bid if subjects have adequately tolerated the study drug in the opinion of the Investigator. |
| Name | Type | Description |
|---|---|---|
| Fostamatinib disodium | DRUG | Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg. |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Subject must be willing and able to give written informed consent by signing an IRB approved Informed Consent Form prior to undergoing any study-specific procedures. 2. Subject must have completed all 24 weeks of participation in the study C-935788-057. Exclusion Criteria: ...