rVA576 in Adult Mild to Moderate Bullous Pemphigoid Subjects
Summary
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
Timeline
- Start
- 2018-09-25
- Primary completion
- 2020-03-12
- Completion
- 2020-04-29
Outcome
Met primary endpoint
release “By Day 7, 21 and 42 of treatment with Nomacopan (Coversin), the BPDAI global score fell by a mean of 31%, 45% and 52%, respectively.” akaritx.com ↗
release “The four patients saw a rapid and significant improvement in symptoms, with a mean 63% decline in Bullous Pemphigoid Disease Area Index” akaritx.com ↗
release “achieved the primary and secondary endpoints for nomacopan in its fully recruited Phase II trial in BP” akaritx.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rVA576 | Protein / enzyme biologic | 30 mg | Subcutaneous |