NCT02128269

Phase IIa Trial of ALXN1007 for the Treatment of Non-criteria Manifestations of Antiphospholipid Syndrome

An Open-Label Proof of Concept Phase IIa Trial of ALXN1007 for the Treatment of Non-criteria Manifestations of Antiphospholipid Syndrome

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study was to evaluate the safety and tolerability of intravenous (IV) ALXN1007 in persistently antiphospholipid (aPL)-positive patients with at least 1 of the following non-criteria manifestations of APS: aPL-nephropathy, skin ulcers and/or thrombocytopenia.

Conditions

• Antiphospholipid (aPL)-Positive

Interventions

Type	Name	Description
BIOLOGICAL	Study Drug- ALXN1007	10 mg/kg IV q 2 weeks x 12 doses

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2014-05-01
• Last updated: 2017-07-13
• Results posted: 2017-07-13

Locations

9 sites across 6 countries: United States, Brazil, France, Italy, Japan, United Kingdom