Two global Phase 3 clinical trials, both comparing Sanofi Genzyme’s investigational tolebrutinib with its approved therapy Aubagio, are enrolling a total of 1,800 people with relapsing multiple sclerosis (MS), the company said.
Enrollment is taking place at multiple clinical sites across the U.S, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, Korea, Estonia, Latvia, Puerto Rico, and Spain. More information and contacts can be found on the trials’ pages, here and here.
Tolebrutinib, previously known as SAR442168, is a small molecule inhibitor of the enzyme Bruton tyrosine kinase (BTK), which plays a key role in the activity and survival of immune B-cells. This subset of antibody-producing immune cells is thought to be one of the key drivers of inflammation in MS.
By blocking the activity of BTK and penetrating the brain, tolebrutinib is expected to help lower inflammation in the central nervous system (CNS), comprised of the brain and spinal cord.
The clinical trials, GEMINI 1 (NCT04410978) and GEMINI 2 (NCT04410991), are each enrolling 900 adults, ages 18 to 55, with relapsing MS, which includes relapsing-remitting MS and active secondary progressive MS.
The trials will assess the safety and efficacy of a daily oral dose of tolebrutinib compared to a 14 mg daily dose of Aubagio (teriflunomide), an approved MS therapy also marketed by Sanofi. The studies will be conducted for up to 36 months (three years).
The primary goal of these clinical studies is the reduction of MS relapses, as measured by the annualized relapse rate (ARR). Secondary goals include the effects of treatment on disability progression, disease activity on MRI scans, cognitive performance, quality of life, and laboratory biomarkers of immune and nervous system activity.
Since the studies will involve up to 16 in-person visits to a study site, precautions are being taken to reduce the risk of exposure to COVID-19. Of note, clinical site visits will include MRI scans, blood draws, clinical exams, and questionnaires.
To learn more about the enrollment and eligibility criteria of the GEMINI trials, call 1-800-633-1610 extension option 6, or email [email protected].
In June, the first participant was enrolled in the GEMINI 1 trial.
Sanofi also is conducting the HERCULES trial (NCT04411641), to assess the safety and efficacy of tolebrutinib, compared with a placebo, at delaying disability progression in up to 1,290 patients with non-relapsing (non-active) secondary progressive MS.
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