Patients who
are diagnosed with Relapsing Multiple Sclerosis may qualify for a new study
titled “Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis”.
are diagnosed with Relapsing Multiple Sclerosis may qualify for a new study
titled “Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis”.
The study’s
objective is to assess the safety and effectiveness of the study medication in
reducing the number of new active brain lesions reported with Magnetic
Resonance Imaging (MRI) with patients with Relapsing MS.
objective is to assess the safety and effectiveness of the study medication in
reducing the number of new active brain lesions reported with Magnetic
Resonance Imaging (MRI) with patients with Relapsing MS.
Inclusion
Criteria :
▪ The participant must be aged between 18 to 55 years of age and
have been diagnosed with Relapsing Multiple Sclerosis.
have been diagnosed with Relapsing Multiple Sclerosis.
▪ The participant must have at least 1 documented relapse within the
previous year, ≥2 documented relapses within the previous 2 years, or ≥1 active
Gd- enhancing brain lesion on an MRI scan in the past 6 months and prior to screening.
previous year, ≥2 documented relapses within the previous 2 years, or ≥1 active
Gd- enhancing brain lesion on an MRI scan in the past 6 months and prior to screening.
Exclusion Criteria :
▪ The participant has been diagnosed with Primary-Progressive MS
(PPMS) or with non-relapsing Secondary-Progressive MS (SPMS)
(PPMS) or with non-relapsing Secondary-Progressive MS (SPMS)
▪ The participant has an EDSS score >5.5 at the first screening visit
▪ The participant has had a relapse in the 30 days prior to randomization
Study
medication:
medication:
The study
medication belongs to
a class of
medicines called Bruton’s
tyrosine kinase inhibitors (BTKi), which can reduce the activity of the
BTK enzyme in cells from the body’s immune system.
medication belongs to
a class of
medicines called Bruton’s
tyrosine kinase inhibitors (BTKi), which can reduce the activity of the
BTK enzyme in cells from the body’s immune system.
BTK is a molecule involved in the development of B cells and
microglia, which can be involved in the disease process of MS. By reducing the
B cells and microglia activation, this may decrease inflammation in
the brain.
microglia, which can be involved in the disease process of MS. By reducing the
B cells and microglia activation, this may decrease inflammation in
the brain.
The proposed mechanism of action for the
study medication is to prevent the formation
of new brain lesions in MS.
study medication is to prevent the formation
of new brain lesions in MS.
The study medication will be administered orally (by mouth) as a
tablet.
tablet.
To learn
more about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03889639?term=dri15928&rank=1
more about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03889639?term=dri15928&rank=1
Article Provided by: #MSViewsandNews
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