A Phase 3 Multi-Center Randomized Double-Blind Placebo-Controlled Study of Fostamatinib Disodium in the Treatment of wAIHA

  • STATUS
    Recruiting
  • End date
    Mar 31, 2022
  • participants needed
    90
  • sponsor
    Rigel Pharmaceuticals
Updated on 31 July 2021

Summary

The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

Details
Condition Warm Antibody Autoimmune Hemolytic Anemia
Treatment Placebo, Fostamatinib disodium
Clinical Study IdentifierNCT03764618
SponsorRigel Pharmaceuticals
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject must have a diagnosis of primary or secondary wAIHA as documented by a positive direct antiglobulin test (DAT) specific for anti-IgG or anti-IgA
Have failed or not tolerated at least one prior wAIHA treatment regimen, including steroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, MMF, danazol, vincristine, ESA or splenectomy (folate, iron or other supplements do not fulfill this criterion)
Have haptoglobin <LLN or total bilirubin >ULN or lactate dehydrogenase (LDH) >ULN
At screening, subject's hemoglobin level must be 9 g/dL OR if hemoglobin value >9 g/dL and <10 g/dL, subject must be on an allowed wAIHA treatment AND the subject must have documented symptoms related to anemia (e.g., weakness, dizziness, fatigue, shortness of breath, chest pain)
Male or female at least 18 years of age at screening
Karnofsky performance status (KPS) 70
Subject's concurrent treatment for wAIHA may consist of no more than two of any of the following agents: azathioprine, steroids, ESAs, mycophenolate mofetil, dapsone or danazol at a stable dose

Exclusion Criteria

Subject with other types of AIHA (e.g., cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria)
Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosus (SLE), or lymphoid malignancy if the underlying disease is not stable or is not well-controlled on current therapy, per investigator medical judgement
Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure 135 mmHg or diastolic blood pressure 85 mmHg, whether or not the subject is receiving anti-hypertensive treatment
Subject has one or more of the following laboratory abnormalities at screening: neutrophil count of <1,000/L or platelet count of <30,000/L, unless due to Evans syndrome; transaminase levels (i.e., alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) >1.5 x ULN
Has documented active hepatitis B or hepatitis C infection or HIV infection
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