Comparing 4 approaches for multiple sclerosis

Exclusion

• −Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, gastrointestinal or other major diseases
• −History of hypersensitivity to biologic agents or any of the excipients in the formulation
• −Positive result on human immunodeficiency virus (HIV1) and HIV2, hepatitis C, or hepatitis B
• −Evidence of clinical disease activity as defined by any clinical relapse within 3 months prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, or by \>1 clinical relapse within 12 months prior to screening
• −Evidence of brain magnetic resonance imaging (MRI) activity as defined by the presence of ≥ 1 Gadolinium (Gd)-enhancing T1 lesion in the screening MRI scan or by ≥ 4 new or enlarging T2 lesions in the screening scan as compared to a reference scan
• −Participants who have active progressive multifocal leukoencephalopathy (PML), have had confirmed PML, or have a high degree of suspicion for PML
• −Known presence of other neurological disorders that may mimic MS including but not limited to: neuromyelitis optica spectrum disease, Lyme disease, untreated Vitamin B12 deficiency, neurosarcoidosis, cerebrovascular disorders, and untreated hypothyroidism
• −Known active or uncontrolled bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds, including participants exhibiting symptoms consistent with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 6 weeks prior to Day 1
• −Participants with a current diagnosis of epilepsy
• −History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening. Basal or squamous cell carcinoma of the skin that has been excised and is considered cured and in situ carcinoma of the cervix treated with apparent success by curative therapy \>1 year prior to screening is not exclusionary
• −History of inflammatory bowel disease or other clinically significant gastrointestinal disorders
• −Any concomitant disease that may require treatment with systemic corticosteroids or immunosuppressants during course of the study
• −History of currently active primary or secondary (non-drug-related) immunodeficiency
• −Only for cohortsCohortA group of participants sharing a characteristic, followed together.Read more → where CSF samples are planned to be collected: Participants with a history of spinal cord compression, raised intra-cerebral pressure, clinically significant vertebral joint pathology or any other current abnormalities in the lumbar region which could prevent the lumbar puncture procedure.
• −Prior/Concomitant Therapy:
• −Treatment with any approved MS treatment at Screening. Participants may become eligible after completion of a washout periodWashout periodA gap with no treatment, so the previous one clears your system.Read more → prior to acquiring any screening laboratory tests but should not be withdrawn from therapies for the sole purpose of meeting eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → for the trial
• −Previous treatment with anti-CD20 B-cell-depleting therapies (e.g., rituximab, ocrelizumab, or ofatumumab)
• −\<12 months prior to acquiring any screening laboratory tests,
• −≥12 months prior to acquiring any screening laboratory tests, if B-cells are outside the normal range, or not back to individual baselineBaselineYour starting measurements, taken before treatment begins.Read more → ± 20% (if data are available),
• −If discontinuation of a prior B-cell depletion therapy was motivated by safety reasons
• −Current or prior treatment with natalizumab (if \<24 months prior to acquiring any screening laboratory tests)
• −Prior/Concurrent Clinical Study Experience:
• −\- Participation in an investigational drug medicinal product or medical device study within 30 days before Screening or within five times the pharmacodynamic (PD) or pharmacokineticPharmacokineticsThe study of how the body absorbs, distributes, and clears a treatment.Read more → (PK) half-life (if known), whichever is longer
• −Diagnostic Assessments:
• −Participants with SI or behavior within 6 months prior to Screening or participants who, in the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s judgment, pose a suicidal or homicidal risk
• −Vaccination with a live or live-attenuated vaccine within 6 weeks prior to Day 1
• −Previous treatment with RO7121932, alemtuzumab, cladribine, mitoxantrone, cyclophosphamide, total body irradiation, bone marrow transplantation, and hematopoietic stem cell transplantation. For the USA only, previous treatment with daclizumab