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

Study Overview
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Brief Summary
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The primary objective of this study is: • To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

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

Conditions
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Warm Antibody Autoimmune Hemolytic Anemia

Intervention / Treatment
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* Drug: Fostamatinib disodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fostamatinib<br>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. | Drug: Fostamatinib disodium<br>* Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg.<br>* Other names: Fostamatinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study | 104 weeks | 
| Blood Pressure | Change from baseline in blood pressure over time | 104 weeks | 
| Absolute Neutrophil Count (ANC) | Change from baseline in absolute neutrophil count (ANC) over time | 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of Durable Hemoglobin Response |  | 24 weeks | 
| Total Duration of Response |  | During the Intervention period up to 104 weeks | 
| Corticosteroid dose | Net cumulative change from Baseline in corticosteroid dose | During the Intervention period up to 104 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wAIHA, Warm Antibody Autoimmune Hemolytic Anemia, Warm Autoimmune Hemolytic Anemia