Policy & Regulation
Merck commences two global Phase III trials of Evobrutinib
12 September 2019 -

United States-based Merck has started two global pivotal Phase III trials named EVOLUTION RMS one and two for the study of Evobrutinib, it was reported yesterday.

The product is an oral, highly selective Bruton's Tyrosine Kinase inhibitor aimed at treating relapsing multiple sclerosis in adults. It is entering Phase III trials following the results of the Phase II clinical trial that met its primary endpoint over 24 weeks of treatment, where the total cumulative number of T1 gadolinium-enhancing (Gd+) lesions fell against placebo. The reduction of T1 gadolinium-enhancing lesions was observed at 12 weeks and maintained through 48 weeks with evobrutinib 75mg and 75mg BID twice daily.

Both the trials are multicentre, randomised, parallel group, double-blind, active-controlled studies comparing the product twice-daily with interferon beta-1a offered intramuscularly once a week. The primary endpoint of both studies is annualised relapse rate at Week 96. Secondary endpoints include time to first occurrence of 12- and 24-week confirmed Expanded Disability Status Scale Progression and total number of Gd+ T1 lesions and new or enlarging T2 lesions evaluated by MRI.

Trial recruitment is underway with the aim of having 1,900 patients enrolled. The company aims to complete the target in June 2023.

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