Bullous pemphigoid (BP) is the most common of the autoimmune blistering skin diseases in Western Europe. \[Joly 2012\]The study will recruit the new onset or relapsing mild to moderate BP patients. The study population will consist of patients above the age of 18 years with an active episode of BP, confirmed by inclusion and exclusion criteria and who, in the opinion of the Investigator, would benefit from treatment with rVA576. Recombinant rVA576 is a small protein complement C5 and LTB4 inhibitor, which prevents the cleavage of C5 by C5 convertase and thereby inhibits generation of C5b-9 the membrane attack complex (MAC), as well as preventing the release of the anaphylatoxin C5a. rVA576 is effective in inhibiting terminal complement activity irrespective of the activating pathway (classical, lectin or alternative). This Phase IIa open-label single-arm study will evaluate the safety and efficacy of rVA576 in adult mild to moderate Bullous Pemphigoid patients
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult male or female ≥18-year-old patients
✓. Subject with newly presenting mild to moderate cutaneous bullous pemphigoid (BP)
✓. BPDAI global score at the screening of 10-56 (≥ 10 but \<56)
✓. Subjects with a relapse of mild to moderate bullous pemphigoid are eligible if their disease was quiescent for at least 2 months before the current relapse.
✓. Cutaneous bullous pemphigoid (BP) per standard diagnostic criteria:
✓. Clinical presentation (cutaneous blistering and/or itchy dermatosis), AND
✓. Direct immunofluorescence (DIF) studies.
✓. Karnofsky performance status ≥ 60%
Exclusion criteria
✕. Patients with severe BP. Severe disease to defined as global BPDAI ≥ 56.
✕. Concomitant skin conditions preventing physical evaluation of BP.
✕. Participation in a clinical trial of an investigational product within 6 weeks of screening.
✕. Known hypersensitivity to tick or to rVA576 and any of its excipients.
✕. BP patients on systemic corticosteroid or systemic immunomodulator or other treatment for the current BP episode (including azathioprine, dapsone, doxycycline, etc) provided the treatment cannot be discontinued before Day 1.
✕. Treatment with biologics (e.g. etanercept, adalimumab, ustekinumab, infliximab, intravenous immunoglobulin (IVIG) and rituximab or other anti-CD20 therapies) within 5 half-lives of the drugs prior to screening.