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Clinical Trial Summary

Topical rVA576 for treatment of atopic keratoconjunctivitis: a randomised placebo-controlled double masked parallel trial (TRACKER)


Clinical Trial Description

Recombinant rVA576 is a small protein (16.7kDa) which has two independent actions. It inhibits the activation and cleavage of complement C5 and it binds and inactivates leukotriene B4 (LTB4). It acts on the complement system by preventing the cleavage of C5 by C5 convertase into C5a and C5b and so is effective in inhibiting terminal complement activity irrespective of the activating pathway. Atopic keratoconjunctivitis (AKC) is a type of allergic conjunctivitis which involves mast cell activation due to the predominance of inflammatory mediators such as eosinophils and Th2-generated cytokines (Mishra et al. 2011). Recombinant rVA576 eye drops solution is the investigational medicinal product. It is intended for ophthalmic use by topical administration to the eye. Recombinant rVA576 is a compact small protein molecule with a lipocalin-like structure consisting of alpha helices and a beta barrel. There is a surface-active site which binds to the complement C5 molecule with a high affinity (KD 1.85 x 10-8 M) and an internalised active site which binds the small eicosinoid molecule leukotriene B4 (Hepburn et al. 2007). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04037891
Study type Interventional
Source AKARI Therapeutics
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date February 20, 2019
Completion date December 15, 2020