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Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (“APS ACTION”) International Clinical Database and Repository (APS ACTION)
Rochester, Minn.
The purpose of this study is to establish an international secure, web-based clinical database andrepository of aPL-positive patients that the natural course of at least 2000 patients can be followed over 10 years.
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Targeting CD38 with Daratumumab in Primary Antiphospholipid Syndrome: A Phase 1b Dose Escalation Safety Trial
Rochester, Minn.
The Primary Objective is to determine the safety of daratumumab in antiphospholipid syndrome (APS), defined as Dose Limiting Toxicities (DLTs) occurring during the dose escalation phase.The trial is a phase 1b open-label study of daratumumab in participants with APS.
The study design is a modification of the 3 + 3 dose escalation scheme. Three daratumumab dose cohorts are planned: 4 mg/kg, 8 mg/kg, and 16 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48. Total study duration target is 42 months (3 years, 6 months).
• Enrollment phase target is 31 months.
• Study participation phase is 11 months.
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The ANSWERS Study (ANtiphospholipid Syndrome- Working to Establish Real Solutions)
Rochester, Minn.
The purpose of this study is to better understand Antiphospholipid syndrome (APS) pathophysiology and to aid development of targeted therapeutics.
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