Open Label, Phase IIa of ALXN1007 for Antiphospholipid Syndrome
Research type
Research Study
Full title
AN OPEN-LABEL PROOF OF CONCEPT PHASE IIA TRIAL OF ALXN1007 FOR THE TREATMENT OF NON-CRITERIA MANIFESTATIONS OF ANTIPHOSPHOLIPID SYNDROME
IRAS ID
135830
Contact name
Hannah Cohen
Contact email
Sponsor organisation
Alexion Pharmaceuticals Inc.
Eudract number
2013-003588-73
Research summary
This is an open-label, proof of concept, non-randomised, single arm, multi-center clinical study designed to evaluate ALXN1007 (study drug) when administered intravenously in adult patients with selected non-criteria manifestations of Antiphospholipid Syndrome (APS).
Antiphospholipid syndrome (APS) is sometimes known as ‘sticky blood syndrome’ or Hughes syndrome. APS can cause blood clotting in the arteries or veins and is a major cause of recurrent miscarriage. It’s also one of the most common causes of strokes in young people. It’s estimated that 1 in 5 people who’ve had a stroke before the age of 40 may have APS. APS affects all age groups but is most common between the ages of 20 and 50. It seems to affect the health of women more than men because of its effect in pregnancy. It was first diagnosed in people who had lupus (systemic lupus erythematosus - a systemic autoimmune disease that causes inflammation in various parts of the body) but it was later discovered that APS can exist in people who don’t have lupus or any other disease. APS that exists on its own is called primary APS.
There are 3 periods to this study: Screening Period (6 weeks), Treatment Period (24 weeks) and Follow-up Period (12 weeks).
ALXN1007 will be administered as a continuous intravenous infusion over 60 minutes every 2 weeks. Patients will receive a total of 12 doses.
20 patients aged between 18-75 years of age and will be recruited from approximately 6 study centers in North America and Europe, with 1 planned site in the UK.REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/0851
Date of REC Opinion
28 Jul 2014
REC opinion
Further Information Favourable Opinion