This is a long-term extension trial of RAY121 in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
144
Injection
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Westmead Hospital
Sydney, New South Wales, Australia
Campbelltown Public Hospital
Sydney, New South Wales, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Box Hill Hospital
Melbourne, Victoria, Australia
AKH - Medizinische Universitaet Wien, Abteilung fuer Klinische Pharmakologie
Adverse events (AEs)
Incidence, severity, and causal relationship of AEs
Time frame: Baseline to Week 52
RAY121 concentration
Serum RAY121 concentration
Time frame: Baseline to Week 52
Change from baseline in active C1s
Concentration of active C1s will be measured and assessed against baseline values
Time frame: Baseline to Week 52
Change from baseline in total C1s
Concentration of total C1s will be measured and assessed against baseline values
Time frame: Baseline to Week 52
Change from baseline in complement activity (classical pathway)
Level of complement activity (classical pathway) will be measured and assessed against baseline values
Time frame: Baseline to Week 52
Anti-RAY121 antibodies
Titer of anti-RAY121 antibodies
Time frame: Baseline to Week 52
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