A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Launched by RIGEL PHARMACEUTICALS · Oct 23, 2019

Keywords

ClinConnect Summary

This is a Phase 3 open‑label extension study to test the long‑term safety of fostamatinib for adults with warm antibody autoimmune hemolytic anemia (wAIHA). It’s a single‑group trial, so all participants receive fostamatinib and there is no placebo. If you previously took part in the earlier study and had a hemoglobin response, you can continue at the dose you were using at Week 22; new participants start fostamatinib at 100 mg by mouth twice a day, with a possible increase to 150 mg twice daily after Week 4 if you tolerate it well. The study plans to enroll about 90 people and will follow participants for up to about 104 weeks to look at safety and several blood-related outcomes.

To be eligible, you would need to be 18 to 100 years old and have already completed at least 24 weeks in the prior trial (the C-935788-057 study). People who stopped the earlier study before Week 24 aren’t eligible. Participants will have regular safety checks, including reporting any adverse events, monitoring blood pressure, and tracking a type of white blood cell count (absolute neutrophil count). Other important goals include seeing how long hemoglobin improvements last, total time with a response, and changes in corticosteroid use during the extension. The study is conducted at many centers worldwide and led by Rigel Pharmaceuticals, with oversight by a data monitoring committee.

Gender

ALL

Eligibility criteria

• 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:
• • 1. Any subject who discontinued participation in Study C-935788-057 prior to Week 24.