First patient is enrolled in phase IV, multi-center, multiple-dose, open-label study to assess the effects of Acthar Gel as a therapy option in patients with severe keratitis.- Mallinckrodt

Mallinckrodt Plc, confirmed enrollment of the first patient in the company's Phase IV, multi-center, multiple-dose, open-label study to assess the effects of Acthar Gel as a therapy option in patients with severe keratitis.

About the Trial : The Phase IV clinical study is titled "A Multicenter, Open-Label Study to Assess the Efficacy and Safety of Acthar Gel in Subjects with Severe Keratitis." This is a Phase IV, multicenter, multiple dose, open label study to examine the effects of Acthar in adult subjects, with a target enrollment of 30. Subjects with current severe keratitis who meet entry criteria will be treated with Acthar Gel 1 mL (80 units [U]) subcutaneously (SC) two times per week for 12 weeks. Initial treatment will be followed by a taper to Acthar 1 mL (80 U) SC once a week for two weeks, then 0.5 mL (40 U) SC once a week for two weeks. Response will be evaluated by determining the proportion of patients who improved on the Impact of Dry Eye on Everyday Life scale (time frame: from baseline to 12 weeks) and the proportion of subjects who show improvement from baseline in the IDEEL symptom bother score at 12 weeks.

Comment: Acthar Gel is approved by the FDA for the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa � such as keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation � one of the product's 19 indications.