Comparing remibrutinib and teriflunomide for Multiple Sclerosis

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    What is this study about?

    This study is all about comparing two treatments for relapsing multiple sclerosis (RMS)—a medicine called remibrutinib and another one called teriflunomide. Initially, researchers will do what’s known as a ‘double-blind, which means neither the participants nor the researchers know which treatment the participant takes. This part of the study will involve about 800 people and will go for up to 30 months. After this, the participants can continue the study openly taking remibrutinib for up to 5 years. The study will measure things like how often the MS relapses, changes in disability scale, amount of new lesions, changes in blood markers, walking and arm function, mood, pain, and deviations in various health parameters. There will be a lesser version trial simultaneously, with results from both pooled for analysis.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Edegem , Belgium

      Jette , Belgium

      Antwerpen , Belgium

      Ath , Belgium

      Brasschaat , Belgium

      Brugge , Belgium

      Lier , Belgium

      Melsbroek , Belgium

      Pelt , Belgium

      Pleven , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Slagelse , Denmark

      Montichiari , Italy

      Milano , Italy

      Roma , Italy

      Roma , Italy

      Verona , Italy

      Napoli , Italy

      Breda , Netherlands

      Hertogenbosch , Netherlands

      Rotterdam , Netherlands

      Wroclaw , Poland

      Bydgoszcz , Poland

      Kielce , Poland

      Lodz , Poland

      Lodz , Poland

      Piotrkow Trybunalski , Poland

      Poznan , Poland

      Rzeszow , Poland

      Szczecin , Poland

      Kosice , Slovakia

      Bratislava , Slovakia

      Nitra , Slovakia

      Trnava , Slovakia

      Cadiz , Spain

      Cordoba , Spain

      Malaga , Spain

      Sant Joan Despi , Spain

      Salt , Spain

      La Coruna , Spain

      Alcorcon , Spain

      Getafe , Spain

      El Palmar , Spain

      Baracaldo , Spain

      Barcelona , Spain

      Las Palmas de Gran Canaria , Spain

      Leon , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Westbruy On Trym , United Kingdom

      Winchester , United Kingdom


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      In this clinical trial, the steps a patient has to take are as follows:

      1. The Core Part:
        • This is a randomized, double-blind, double-dummy, active comparator-controlled, fixed-dose, parallel-group, multi-center study targeting approximately 800 participants with relapsing multiple sclerosis (RMS).
        • Eligible participants will be randomized in a 1:1 ratio to receive either the study drug remibrutinib (as a tablet) coupled with a matching placebo for the comparator drug teriflunomide (as a capsule), or vice versa, with teriflunomide as the actual medication and a placebo for remibrutinib.
        • Participants are treated up to a maximum of 30 months.
        • Blinding will be maintained using a double-dummy design, meaning all participants receive both drug and placebo in different forms to preserve the blinding.
      2. The Extension Part:
        • This part follows an open-label, single-arm design where eligible participants are treated with the study drug remibrutinib for up to 5 years.
        • Participants on remibrutinib during the Core Part will continue on it, while those initially on teriflunomide will switch to remibrutinib.

      Please note that there are additional details and procedures involved in the clinical trial, including but not limited to visits for monitoring and assessments specific to the objectives of the study.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have a diagnosis of Relapsing Multiple Sclerosis (RMS) according to the 2017 McDonald diagnostic criteria. Additionally, you must have at least one of the following:

      1. 1 documented relapse within the previous year,
      2. 2 documented relapses within the previous 2 years, or
      3. 1 active Gadolinium (Gd)-enhancing lesion in the last 12 months.

      .


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here are the conditions that you must meet to join the study, along with explanations for medical terms where applicable:

      1. Age between 18 to 55 years
      2. Diagnosis of Relapsing Multiple Sclerosis (RMS)
        • This diagnosis should be made according to the 2017 McDonald diagnostic criteria, which are specific guidelines used for diagnosing multiple sclerosis (MS).
      3. Documented Relapses
        • You must have had at least one documented relapse within the previous year, or two documented relapses within the previous two years.
      4. Active Gadolinium (Gd)-Enhancing Lesion
        • If you have not had the relapses mentioned above, you can also qualify if you have had at least one active lesion in the brain or spinal cord that enhances when a special dye called gadolinium is used during an MRI scan within the last 12 months. Gadolinium-enhancing lesions indicate active inflammation in the central nervous system.
      5. EDSS Score of 0 to 5.5 (inclusive)
        • The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. An EDSS score between 0 to 5.5 indicates that the person has a range of disability levels from no noticeable disability (0) to some disability but can walk without aid or rest for at least 200 meters (5.5).
      6. Neurologically Stable within 1 Month
        • This means that your neurological status has not changed significantly in the month before joining the study, indicating no recent major relapses or new neurological symptoms.

      These are the inclusion criteria for the study based on the provided document.

      What Reasons Could Exclude Me from the Study?

      Here is a list of conditions that would exclude you from taking part in the study, along with explanations of the medical terms:

      1. Diagnosis of primary progressive multiple sclerosis (PPMS): PPMS is a type of MS that steadily worsens from its onset with no relapses or remissions.
      2. Disease duration of more than 10 years in participants with EDSS score of 2 or less at screening: EDSS (Expanded Disability Status Scale) measures disability in MS. A score of 2 or less indicates minimal disability.
      3. History of clinically significant CNS disease other than MS: CNS (Central Nervous System) diseases include conditions affecting the brain and spinal cord.
      4. Ongoing substance abuse (drug or alcohol): Regular misuse of drugs or alcohol that could affect study participation or results.
      5. History of malignancy: A history of cancer, except for treated non-spreading skin cancer or cervical cancer in situ (early stage).
      6. Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that is usually fatal or leads to severe disability.
      7. Suicidal ideation or behavior: Thoughts or actions related to self-harm or suicide.
      8. Evidence of clinically significant cardiovascular, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders or gastrointestinal disease: Serious conditions related to the heart, lungs, kidneys, liver, hormone-producing glands, metabolism, blood, or digestive system could affect the study.
      9. Participants who have had a splenectomy: Surgical removal of the spleen, an organ involved in immune response and blood filtration.
      10. Active systematic infections: Ongoing bacterial, viral, parasitic, or fungal infections that are significant.
      11. Positive results for syphilis or tuberculosis testing: Indicates presence of these infectious diseases.
      12. Uncontrolled disease states where flares are commonly treated with oral or parenteral corticosteroids: Conditions like asthma or inflammatory bowel disease that require steroids to manage sudden worsening of symptoms.
      13. Active, chronic disease of the immune system other than MS: Conditions such as rheumatoid arthritis, lupus, etc., that affect the immune system.
      14. Immunodeficiency syndrome or HIV positive: Compromised immune system or infection with the HIV virus.
      15. History or current treatment for hepatic disease: Including liver diseases like hepatitis or cirrhosis.
      16. Severe renal disease or abnormal creatinine level: Indicates kidney dysfunction.
      17. Risk of hepatitis reactivation: Potential for the hepatitis virus to become active again in the body.
      18. Abnormal hematology parameters: Imbalances in blood components like hemoglobin, platelets, lymphocytes, white blood cells, and neutrophils.
      19. Significant ECG abnormalities: Irregularities in the heart’s electrical activity detected by an electrocardiogram.
      20. Use of other investigational drugs: Participation in other drug trials that could interfere with this study.
      21. Requirement for anticoagulant medication or significant bleeding risk or coagulation disorders: Use of blood thinners or conditions that affect blood clotting.
      22. Major surgery within 8 weeks prior to screening: Recent surgery that might affect study participation.
      23. History of hypersensitivity to any of the study drugs or excipients: Allergies to the study medication or its ingredients.
      24. Pregnant or nursing females
      25. Women of childbearing potential not using highly effective contraception
      26. Sexually active males not agreeing to use a condom
      27. Use of strong CYP3A4 inhibitors or strong CYP3A4 inducers within two weeks prior to randomization: These are drugs that significantly affect how drugs are metabolized in the body.

      This information is derived from the study’s exclusion criteria.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are:

      1. Remibrutinib (LOU064) – This is a tablet taken orally that belongs to the experimental arm of the study. Remibrutinib is an active substance known as Bruton’s tyrosine kinase (BTK) inhibitor. It is used to potentially reduce the activity of B-cells and myeloid cells, which play a role in the inflammation and neuronal damage associated with multiple sclerosis.
      2. Teriflunomide – This drug is used as an active comparator in the study. It is a capsule taken orally. The active substance, teriflunomide, is an immunomodulatory agent with anti-inflammatory properties. It is believed to reduce the number of activated lymphocytes in the central nervous system (CNS), which may be involved in the pathogenesis of multiple sclerosis.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substances participating in the clinical trial are known to medicine and the medical literature. Here is a list of the substances along with a description for each:

      1. Remibrutinib: Remibrutinib is used in this clinical trial in a tablet form taken orally. While I don’t have information in my current source about its previous use in medical literature, this compound is involved in the core experimental treatment as well as the extension phases of the trial.
      2. Teriflunomide: Teriflunomide is an active comparator in the clinical trial and is known to the medical community, as it is currently used for treating relapsing forms of multiple sclerosis under the brand name Aubagio. In this trial, it is used in capsule form taken orally.

      Both substances are part of a study to compare the efficacy and safety in participants with relapsing multiple sclerosis.


      Study ID

      CT-EU-00057167

      Recruitment status

      Recruting new patients

      Start of the trial

      3 years ago

      Study phase

      Phase
      III

      Medicinal Product