A study to assess the safety and efficacy of BIIB091 in participants with relapsing multiple sclerosis

Kriterien zur Teilnahme
1. The participant must be between 18 and 55 years old and must be able to provide a diagnosis of RMS with MS symptoms that occurred less than 20 years ago. At screening, the participant must have an EDSS score of 0 to 5.0 and at least one of the following points must have occurred: - at least 2 clinical relapses in the last 24 months with at least one relapse in the last 12 months prior to randomization AND/OR - at least 1 clinical relapse in the last 24 months and at least 1 new brain MRI lesion within the last 12 months prior to randomization AND/OR - at least 1 GdE (Gadolinium-enhancing) lesion on brain MRI in the last 6 months prior to randomization. 2. The participant and/or their legal representative must be able to understand the purpose and risks of the study, provide informed consent, and approve the use of confidential health data in accordance with national and local data protection regulations. 3. Contraception: Female participants of childbearing potential and male participants must use a highly effective or effective method of contraception during the study and for at least 30 days after the last dose of the study treatment. Additionally, all participants should not donate eggs or sperm during the study and for at least 30 days after the last dose of the study treatment. (BASEC)

Ausschlusskriterien
1. Medical history and current health status Diagnosis of primary progressive multiple sclerosis (PPMS) History of or ongoing - Severe allergic, anaphylactic reactions or hypersensitivity reactions to BIIB091, DRF or any of the components of the study medication - Malignant diseases, including solid and hematological tumors - Clinically relevant cardiac, endocrinological, hematological, immunological, infectious, metabolic, urological, pulmonary, neurological (other than MS), dermatological, psychiatric, renal or other serious diseases that are not well controlled and determined by the investigator. - Gilbert's syndrome or any other clinically relevant liver disease, as determined by the investigator, including but not limited to viral hepatitis, alcoholic hepatitis and steatosis, non-alcoholic steatohepatitis, cirrhosis or autoimmune hepatitis. - Any clinically significant pancreatic disease determined by the investigator, including (but not limited to) acute provoked pancreatitis in the last 12 months, idiopathic acute pancreatitis or chronic pancreatitis. - Gastrointestinal surgery (except appendectomy or cholecystectomy that occurred more than 6 months before screening), irritable bowel syndrome, inflammatory bowel disease (Crohn's disease, ulcerative colitis) or any other clinically relevant and active GI disease at the discretion of the investigator. - ECG abnormalities - Torsade de pointes or additional risk factors for torsade de pointes or ventricular arrhythmias - Bleeding due to diathesis, gastrointestinal bleeding or severe bleeding. - Receipt of a vaccination within 30 days prior to screening or plans to receive a vaccination up to 30 days after the last study visit (a non-live COVID-19 vaccine is allowed if completed at least 21 days before the study start) - Contraindications for MRI - Mental or physical condition that excludes the conduct of efficacy and safety assessments. - Any major surgical procedures within 4 weeks prior to screening or planned elective procedures or surgeries 2. Infection risk - Signs of a SARS-CoV-2 infection in the last 4 weeks prior to study start, including (but not limited to) symptoms indicating a SARS-CoV-2 infection or close contact with a person with a SARS-CoV-2 infection within 14 days prior to study start - Past or current positive test result on screening for HIV, hepatitis C or hepatitis B (participants with immunity to hepatitis B after vaccination may participate in the study) - Chronic or recurrent severe infection - Symptoms of a bacterial, fungal or viral infection - Tuberculosis in history or positive tuberculosis test result prior to study start 3. Medications Previous treatments with: - BTK inhibitors (including BIIB091) - Anti-CD20 antibodies - DMF, DRF, or MMF-containing medications within 2 months prior to study start - Alemtuzumab, Mitoxantrone, Cyclophosphamide, Cladribine, T-cell or T-cell receptor vaccines, total body or lymphoid irradiation or stem cell transplantation - Other immunosuppressive medications within 1 year prior to study start - Teriflunomide within 3 months after study start - Natalizumab and others within 3 months prior to study start - Treatment with Dalfampridine (Ampyra®), unless you have been receiving a constant dose for at least 30 days prior to study start - Symptomatic therapies including (but not limited to) therapies for spasticity, depression or fatigue, unless you have been receiving a constant treatment regimen for at least 30 days prior to study start - Opioid treatment within 28 days prior to screening - Participation in another clinical study in the last 90 days prior to study start (or within 5 half-lives of the other drug or therapy, whichever period is longer) Use of: - Substances known to inhibit or induce drug-metabolizing enzymes (e.g., barbiturates, phenothiazines) - Traditional and/or unapproved drugs (or therapies) or herbal preparations that affect MS - All prescription medications that prolong the QT/QTc interval - Anticoagulants or antiplatelet agents (low-dose aspirin up to 100 mg is allowed) - CYP3A4 inducers or inhibitors, including hormonal contraceptives (BASEC)