A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA) (SOAR)

Rigel Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Warm Antibody Autoimmune Hemolytic Anemia

Treatments: Drug: Fostamatinib 150 mg bid

Study type: Interventional

Funder types: Industry

Identifiers

NCT02612558

C-935788-053

Details and patient eligibility

About

The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subject must have had a diagnosis of primary or secondary warm antibody AIHA.

• Must have failed at least 1 prior treatment regimen for AIHA.

Exclusion criteria

• Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria.
• Subject with a platelet count of < 30,000/μL.
• Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy.
• Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 130 mmHg, or diastolic blood pressure ≥ 80 mmHg.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Fostamatinib 150 mg

Experimental group

Description:

Fostamatinib 150 mg bid (morning and evening) over the course of 24 weeks

Treatment:

Drug: Fostamatinib 150 mg bid