Interested men and women may qualify for a clinical trial if they are between the ages of 18 and 55, with a current diagnosis of relapsing MS or primary progressive MS (PPMS), or between ages 18 and 60 with a diagnosis of non-relapsing secondary progressive MS (SPMS).
To determine their eligibility, patients are invited to fill out an online pre-screening survey. It consists of nine questions related to their MS diagnosis, prior treatments and duration of treatment, additional diseases, use of a wheelchair, and geographical location.
The questionnaire should take about two minutes to complete and provides an immediate assessment of their qualifications, without the need to submit contact information. Those who qualify may then enter more information to be contacted by a trial representative.
Tolebrutinib is designed to reduce inflammation in the central nervous system (the brain and spinal cord) by blocking the action of an enzyme called Bruton tyrosine kinase, known as BTK. BTK plays a key role in the activity and survival of immune B-cells, thought to be one of the key drivers of MS-related inflammation.
Among the four ongoing Phase 3 clinical trials, the GEMINI 1 (NCT04410978) and GEMINI 2 (NCT04410991) are investigating tolebrutinib against the approved medication Aubagio (teriflunomide) in people with relapsing forms of MS.
These trials each seek to enroll approximately 900 adults who experienced at least one relapse in the last year, two or more relapses in the previous two years, or had at least one new inflammatory brain lesion in the year prior to enrollment.
The GEMINI studies primarily seek to assess if tolebrutinub reduces MS relapses among patients. Secondary goals include the evaluation of disability progression, disease activity on magnetic resonance imaging (MRI) scans, cognitive performance, quality of life, and laboratory biomarkers of immune and nervous system activity.
The other two trials, HERCULES (NCT04411641) and PERSEUS (NCT04458051), are testing the safety and efficacy of oral tolebrutinib against a placebo, given over 1-2 years, in people with progressive MS.
HERCULES aims to recruit approximately 1,290 participants with SPMS, ages 18 to 60 years, who have not experienced a relapse in the past two years. PERSEUS seeks 990 adults with PPMS, ages 18 to 55, whose first symptoms appeared up to 15 years earlier.
The two studies primarily aim to assess whether tolebrutinib performs better than a placebo at delaying patients’ disability progression, as measured by the Expanded Disability Status Scale. Secondary goals include safety and tolerability, as well as changes in walking speed, hand dexterity, cognitive function, quality of life, and disease activity, again measured by MRI.
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