drugset / Trial / NCT04037891

Topical rVA576 for Treatment of Atopic Keratoconjunctivitis

NCT04037891 ↗

Phase 1/2 Terminated 12 enrolled AKARI Therapeutics
RandomizedParallel-groupDouble-blindTreatment

Summary

Topical rVA576 for treatment of atopic keratoconjunctivitis (AKC), vernal keratoconjunctivitis (VKC),and severe allergic conjunctivitis (seasonal (SAC) or perennial (PAC)): a randomised placebo-controlled double masked parallel trial (TRACKER)

Timeline

Start
2019-03-04
Primary completion
2020-04-30
Completion
2020-04-30

Outcome

Met primary endpoint

Stopped: “The trial has terminated early due to the disruptions caused by the ongoing COVID-19 pandemic. The decision was not related to any efficacy, safety or clinical concerns regarding rVA576.”

release “Improvement in mean composite clinical efficacy score of 35% by Day 14 and 55% by Day 56.” akaritx.com ↗

release “Part A of AKC Phase I/II study completed with a rapid mean 55% improvement in the composite clinical score at day 56” akaritx.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject rVA576 Protein / enzyme biologic — Topical