Today, we will be looking into the latest research and clinical trials focused on multiple sclerosis.

The following list has been carefully curated by evaluating the ongoing phase 3 trials for multiple sclerosis, targeting adults in the United States. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 12 months.

This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.

Now, let’s go ahead and explore the list of Multiple Sclerosis Clinical Trials!

Quick View Table of Multiple Sclerosis Clinical Trials
Study TitlePhaseEnrollmentStart DateLast Update Posted
A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis (OLIKOS)PHASE 311110/19/2020 12/27/2024
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)PHASE 38996/11/20209/19/2024
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)PHASE 39746/30/20209/19/2024
Study of Evobrutinib in Participants With RMS (evolutionRMS 1)PHASE 311246/12/20204/29/2024
Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)PHASE 311319/24/20202/3/2025
Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related EpilepsyPHASE 31284/1/202211/5/2024

Phase 3 Clinical Trials:

A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis (OLIKOS)

Study Details | Source

  • Sponsor: Novartis Pharmaceuticals
  • A single arm study evaluating the continued efficacy, safety and tolerability of ofatumumab in patients with relapsing multiple sclerosis who are transitioning from aCD20 mAb therapy
  • Interventions:
    • Drug: Ofatumumab
  • Primary Outcomes Measures:
    • Percentage of Participants With no Change or a Reduction From Baseline in the Number of Gadolinium Enhancing (GdE) Lesions at Month 12 Using Non-responder Imputation
      • Magnetic Resonance Imaging (MRI) was used to measure presence of new or reduction in number of gadolinium enhancing T1 lesions. Each MRI scan was previewed by a local neuroradiologist. The quality of each scan performed was assessed by a central MRI reading center and evaluated for quality, completeness and adherence to the protocol.
      • A nonresponder imputation (NRI) for missing data approach was applied. NRI assumes that a participant was a treatment failure, i.e. non-responder, if they did not have a valid Month 12 MRI assessment, or if they discontinued the study prematurely and did not have a valid Month 12 MRI assessment.
        • Time frame - Baseline (assessed at screening visit), Month 12
    • Percentage of Participants With no Change or a Reduction From Baseline in the Number of Gadolinium Enhancing (GdE) Lesions at Month 12 Based on Observed Data
      • Magnetic Resonance Imaging (MRI) was used to measure presence of new or reduction in number of gadolinium enhancing T1 lesions. Each MRI scan was previewed by a local neuroradiologist. The quality of each scan performed was assessed by a central MRI reading center and evaluated for quality, completeness and adherence to the protocol.
      • A sensitivity analysis of the primary endpoint was performed based on an observed data approach.
        • Time frame - Baseline (assessed at screening visit), Month 12

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)

Study Details | Source

  • Sponsor: Sanofi
  • Primary Objective: To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS
  • Secondary Objective: To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate pharmacodynamics (PD) of SAR442168
  • Interventions:
    • Drug: Tolebrutinib
    • Drug: Teriflunomide HMR1726
    • Drug: Placebo to match Tolebrutinib
    • Drug: Placebo to match Teriflunomide
  • Primary Outcomes Measures:
    • Annualized Adjudicated Relapse Rate : Number of confirmed protocol defined adjudicated relapses
      • Annualized Adjudicated Relapse Rate : Number of confirmed protocol defined adjudicated relapses
      • Time frame - Up to approximately 36 months

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)

Study Details | Source

  • Sponsor: Sanofi
  • Primary Objective: To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS
  • Secondary Objective: To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168
  • Interventions:
    • Drug: Tolebrutinib
    • Drug: Teriflunomide HMR1726
    • Drug: Placebo to match Tolebrutinib
    • Drug: Placebo to match Teriflunomide
  • Primary Outcomes Measures:
    • Annualized Adjudicated Relapse Rate : Number of confirmed adjudicated protocol defined relapses
      • Annualized Adjudicated Relapse Rate : Number of confirmed adjudicated protocol defined relapses
      • Time frame - Up to approximately 36 months

Study of Evobrutinib in Participants With RMS (evolutionRMS 1)

Study Details | Source

  • Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
  • The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants who complete the double-blind treatment period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period.
  • Results from the EVOLUTION clinical trials showed evobrutinib did not meet its primary endpoint of annualized relapse rate for up to 156 weeks compared to oral teriflunomide in both studies.
  • Interventions:
    • Drug: Evobrutinib
    • Drug: Placebo (match to Teriflunomide)
    • Drug: Teriflunomide
    • Drug: Placebo (match to Evobrutinib)
  • Primary Outcomes Measures:
    • DBTP: Annualized Relapse Rate (ARR)
      • The annualized relapse rates up to 156 weeks will be calculated based on qualified relapses. Qualifying relapse is defined as occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than 24 hours, no fever, infection, injury, adverse events, and preceded by a stable or improving neurological state for greater than or equal to (=>) 30 days).
      • Time frame - Up to 156 weeks
    • DBE Period: ARR
      • The annualized relapse rates up to 96 weeks will be calculated based on qualified relapses. Qualifying relapse is defined as occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than 24 hours, no fever, infection, injury, adverse events, and preceded by a stable or improving neurological state for greater than or equal to (=>) 30 days).
      • Time frame - Up to 96 weeks
    • OLE Period: Number of Participants with Adverse Events and Serious Adverse Events (SAE)s
      • Time frame - Baseline OLE up to 96 weeks

Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)

Study Details | Source

  • Sponsor: Sanofi
  • Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS
  • Secondary Objective: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites in NRSPMS and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168
  • Interventions:
    • Drug: Tolebrutinib
    • Drug: Placebo to match Tolebrutinib
  • Primary Outcomes Measures:
    • 6-month confirmed disability progression (CDP)
      • Time to onset of 6 months CDP defined as follows: -Increase of ≥1.0 point from the baseline expanded disability status scale (EDSS) score when the baseline score is ≤5.0, or -Increase of ≥0.5 point when the baseline EDSS score is >5.0 -
      • Time frame - Up to 48 approximately months

Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy

Study Details | Source

  • Sponsor: Marinus Pharmaceuticals
  • This is a Phase 3, global, double-blind, randomized, placebo-controlled study of adjunctive GNX treatment in children and adults with TSC-related epilepsy. The study consists of a 4-week prospective Baseline phase, defined as the first 28 days following screening, followed by a double-blind phase consisting of a 4-week titration period (Day 1 to Day 28) and a 12-week maintenance period (Day 29 to Week 16).
  • Interventions:
    • Drug: Ganaxalone
    • Drug: Placebo
  • Primary Outcomes Measures:
    • Double-blind phase: Percent change from Baseline in 28-day seizure frequency during titration and maintenance period
      • Seizure frequency will be calculated as the total number of seizures divided by the number of days with seizure data, multiplied by 28.
      • Time frame - Baseline (Day 1) through Week 16
Potential Guidelines That May Be Affected Include:

And there you have it - a roundup of Phase 3 clinical trials for multiple sclerosis as of March 2025. Stay tuned for our next Guidelines+ Trials Rundown! In the meantime, explore more clinical trials and sign up for alerts to stay up to date with the latest published guidelines and research.

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