Search Results
Master Protocol of Two Independent, Randomized, Double-Blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) To Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis
A study that looks at the efficacy of Frexalimab compared to standard of care drug, Teriflunomide, for adults with relapsing forms of MS.
The purpose of this clinical trial is to compare the efficacy and safety of investigational products in adult participants with relapsing forms of multiple sclerosis. There will be about 22 in person visits over 3.5 years that consist of monthly IV medication administration, monthly oral tablet medication dispensation, Magnetic resonance imaging (MRI) roughly every 6 months, monthly blood draws for lab work, vitals, ECG, and clinical outcome assessments. 13 of these visits are within the first 12 months of the study. All study activities will be done at the Penn State Health Hershey Medical Center in the Neurology Clinic at 30 Hope Drive and the Clinical Research Center (CRC) in the main hospital.
Up to $4300
Diagnosed with remitting relapsing multiple sclerosis (RRMS) with a documented relapse within the previous year, two documented relapses within two years, or one documented Gd enhancing lesion on an MRI scan within the previous year.
Must agree to use contraception for both male and female participants.
Must be able to sign informed consent or have a legally authorized representative to sign.
History of infectious disease/serious psychiatric illness/active substance use disorder/cirrhosis, acute liver disease/malignancy/autoimmune, cardiovascular, neurological disorders/any other history or presence of significant other concomitant illness.
Treatment with lymphoid irradiation, bone marrow transplantation, mitoxantrone, alemtuzumab, cladribine, daclizumab, cyclophosphamide, other strongly immunosuppressive treatments with very long-lasting effects, equal to or over 3 months of teriflunomide.
Previous exposure to frexalimab, other investigational drug trials, allergy or sensitivity to any of the study interventions.
Contraindication for MRI: pacemaker, metallic implants/presence of metallic material in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.
A randomized, double-blind, double-dummy, parallel-group study, comparing the efficacy and safety of remibrutinib versus teriflunomide in participants with relapsing multiple sclerosis, followed by extended treatment with open-label remibrutinib
The main purpose of the study is to find out if patients treated with remibrutinib may experience fewer MS relapses (also called clinical attacks, exacerbations or flare ups) than patients treated with teriflunomide (also known as Aubagio®). Teriflunomide is an approved medication for the treatment of relapsing MS
This study requires you to take a medication. This study consists of a core part (21 in person visits over 2.5 years) and an extension part (18 in person visits over 5 years). Study activities consist of blood draws for labs every 3 months, vitals (blood pressure readings, heart rate, height and weight), physical exam, electrocardiogram (ECG), clinical outcome assessments, a participant diary that will be filled out during treatment, and an optional magnetic resonance imaging (MRI) sub-study. All study activities will be done at the Penn State Health Hershey Medical Center in the neurology clinic at 30 Hope Drive and clinical research center (CRC) in the main hospital.
$3960
Diagnosed with remitting relapsing multiple sclerosis (RRMS) with a documented relapse within the previous year, two documented relapses within previous two years, or one documented Gd enhancing lesion on an MRI scan within the previous year.
Must be neurologically stable for 1 month prior to joining the study (including no MS relapse in this time period)
Must agree to use contraception for both male and female participants
Must be able to sign informed consent or have a legally authorized representative to sign.
MS disease duration of more than 10 years
Any history or presence of significant concomitant illness.
Treatment with some common MS medications such as cladribine, cyclophosphamide, remibrutinib or other BTKi, alemtuzumab
Optional sub-study: contraindication for MRI: any metal in the body or history of metal fragments, claustrophobia, known allergy to contrast medium.
A randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to placebo in adult participants with nonrelapsing secondary progressive multiple sclerosis.
A study that looks at the efficacy of Frexalimab compared to placebo in adults with nonrelapsing secondary progressive MS.
This study explores the efficacy and safety of Frexalimab compared to placebo in delaying disease disability progression in non-relapsing secondary progressive multiple sclerosis (nrSPMS). There will be about 53 in person visits over 4.5 years that consist of monthly IV medication administration, vitals, monthly blood draw for lab work, clinical outcome assessments, ECG, and Magnetic resonance imaging (MRI) roughly every 6 months. All study activities will be done at the Penn State Health Hershey Medical Center in the Neurology Clinic at 30 Hope Drive and Clinical Research Center (CRC) in the main hospital.
Up to $4300
Previous diagnosis of remitting relapsing multiple sclerosis (RRMS) AND absence of clinical relapses for at least 24 months
Current diagnosis of secondary progressive multiple sclerosis (SPMS) and documented evidence of disability progression observed during the 12 months before screening
Must agree to use contraception for male and female participants
Must be able to sign informed consent or have a legally authorized representative (LAR)
Treatment with lymphoid irradiation, bone marrow transplantation, mitoxantrone, alemtuzumab, cladribine, daclizumab, cyclophosphamide, other strongly immunosuppressive treatments with very long-lasting effects.
Previous exposure to frexalimab, other investigational drug trials, allergy or sensitivity to any of the study interventions.
Contraindication for MRI: pacemaker, metallic implants/presence of metallic material in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.