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Oditrasertib

Oditrasertib, also known as SAR443820, is a promising drug currently being studied in clinical trials for its potential benefits in treating multiple sclerosis (MS). This article explores the ongoing research on Oditrasertib, focusing on its effects on serum neurofilament levels and other important aspects of MS progression. The trial aims to assess the drug’s efficacy, safety, and long-term effects in patients with various forms of MS.

Table of Contents

What is ODITRASERTIB?

ODITRASERTIB, also known as SAR443820 or DNL-788, is a new medication being studied for the treatment of multiple sclerosis (MS). Multiple sclerosis is a chronic disease that affects the central nervous system, including the brain, spinal cord, and optic nerves.[1]

This medication is currently undergoing clinical trials to evaluate its effectiveness and safety in treating various forms of MS, including relapsing-remitting MS (RRMS), secondary progressive MS (SPMS), and primary progressive MS (PPMS).

How ODITRASERTIB Works

ODITRASERTIB is classified as a small molecule drug. While the exact mechanism of action is not fully described in the provided information, small molecule drugs typically work by targeting specific proteins or pathways in the body that are involved in the disease process.[1]

In the case of multiple sclerosis, ODITRASERTIB may help reduce inflammation and protect nerve cells from damage, which are key factors in the progression of the disease.

Potential Benefits of ODITRASERTIB

The ongoing clinical trial aims to assess several potential benefits of ODITRASERTIB for MS patients, including:

  • Reduction in serum neurofilament levels (sNfL), which are markers of nerve cell damage[1]
  • Decrease in the number of new or enlarging brain lesions detected by MRI[1]
  • Slowing down of disability progression[1]
  • Improvement in physical function and quality of life[1]
  • Reduction in brain volume loss[1]

Ongoing Research

ODITRASERTIB is currently being studied in a Phase 2 clinical trial. This trial is divided into two parts:

  1. Part A: A 48-week double-blind, randomized, placebo-controlled study to evaluate the effect of ODITRASERTIB on serum neurofilament levels and other measures of disease activity.[1]
  2. Part B: A long-term extension period to assess the durability of the treatment effects and long-term safety.[1]

The study will use various methods to measure the effectiveness of ODITRASERTIB, including:

  • MRI scans: To detect changes in brain lesions and brain volume[1]
  • Clinical assessments: Such as the Expanded Disability Status Scale (EDSS), 9-Hole Peg Test, and timed 25-foot walk test[1]
  • Patient-reported outcomes: To evaluate the impact on quality of life[1]

Who Can Participate in the Study?

The study is open to adults aged 18 to 60 with a diagnosis of RRMS, SPMS, or PPMS. Some key eligibility criteria include:

  • An EDSS score between 2 and 6[1]
  • Stable on allowed disease-modifying therapies or untreated[1]
  • No recent relapses or significant cognitive impairment[1]

It’s important to note that there are additional inclusion and exclusion criteria that a healthcare provider would review with potential participants.

Safety Considerations

As with any new medication, safety is a crucial aspect of the ODITRASERTIB clinical trial. The study will closely monitor for any side effects or adverse events. Some safety measures include:

  • Regular monitoring of laboratory tests[1]
  • Electrocardiogram (ECG) assessments[1]
  • Tracking of adverse events and serious adverse events[1]

It’s important to remember that ODITRASERTIB is still an investigational drug, and its full safety profile is not yet known. Patients considering participation in the clinical trial should discuss the potential risks and benefits with their healthcare provider.

Aspect Details
Drug Name Oditrasertib (SAR443820)
Study Type Phase 2 double-blind, randomized, placebo-controlled study
Main Objective Assess effect on serum neurofilament levels in MS patients
Study Duration Part A: 48 weeks, Part B: up to 96 weeks (long-term extension)
Participant Criteria 18-60 years old, diagnosed with RRMS, SPMS, or PPMS, EDSS score 2-6
Key Outcomes Measured sNfL levels, brain lesions, disability progression, brain volume loss, relapses
Drug Administration Oral, film-coated tablet, max daily dose 20 mg
Safety Assessments Adverse events, laboratory tests, ECG, vital signs

FAQ

  • What is Oditrasertib? Oditrasertib, also known as SAR443820, is an investigational drug being studied for its potential benefits in treating multiple sclerosis. It is a small molecule that is taken orally in the form of a film-coated tablet.
  • What is the main goal of the clinical trial studying Oditrasertib? The main goal of the clinical trial is to assess the effect of Oditrasertib compared to placebo on serum neurofilament (sNfL) levels in participants with multiple sclerosis. The study also aims to evaluate the drug's long-term effects and durability.
  • Who can participate in this clinical trial? Participants must be between 18 and 60 years old, diagnosed with relapsing-remitting MS (RRMS), secondary progressive MS (SPMS), or primary progressive MS. They must have an Expanded Disability Status Scale (EDSS) score between 2 and 6, and meet other specific inclusion criteria.
  • How long does the clinical trial last? The trial consists of two parts: Part A, which lasts 48 weeks, and Part B, an open-label long-term extension period that continues up to 96 weeks. This allows researchers to study both short-term and long-term effects of Oditrasertib.
  • What are some of the key outcomes being measured in this trial? The trial measures several outcomes, including changes in serum neurofilament levels, the number of new brain lesions detected by MRI, disability progression, walking ability, brain volume loss, and the occurrence of relapses. It also assesses the safety and tolerability of Oditrasertib.

Ongoing Clinical Trials on Oditrasertib

  • Study on the Effects of SAR443820 and Gadobutrol in Patients with Multiple Sclerosis

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria France Germany Italy Poland +1

Glossary

  • Serum Neurofilament (sNfL): A protein found in the blood that can indicate damage to nerve cells. In multiple sclerosis, higher levels of sNfL may suggest more active disease or progression.
  • Multiple Sclerosis (MS): A chronic disease affecting the central nervous system, where the immune system mistakenly attacks the protective covering of nerve fibers, causing communication problems between the brain and the rest of the body.
  • Relapsing-Remitting MS (RRMS): A type of MS characterized by clearly defined attacks of new or increasing neurologic symptoms, followed by periods of partial or complete recovery.
  • Secondary Progressive MS (SPMS): A type of MS that initially follows a relapsing-remitting course, but later transitions to a more steadily progressive form of the disease.
  • Primary Progressive MS (PPMS): A type of MS characterized by worsening neurologic function from the onset of symptoms, without early relapses or remissions.
  • Expanded Disability Status Scale (EDSS): A method of quantifying disability in multiple sclerosis, ranging from 0 to 10 in 0.5 unit increments.
  • Gadolinium (Gd)-enhancing lesions: Areas of active inflammation in the brain or spinal cord that can be seen on MRI scans after the injection of a contrast agent called gadolinium.
  • T2 hyperintense lesions: Areas of damage in the brain or spinal cord that appear bright on certain types of MRI scans, indicating past or present inflammation or tissue damage.
  • Brain Volume Loss (BVL): The decrease in overall brain size that can occur in MS, which may be associated with cognitive decline and disability progression.
  • Annualized Relapse Rate (ARR): The average number of relapses a person with MS experiences in a year, used to measure disease activity.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-sar443820-and-gadobutrol-in-patients-with-multiple-sclerosis/