A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous RO7121932 in Participants With Multiple Sclerosis.
Multiple Sclerosis
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria: Expanded Disability Status Scale (EDSS) score ≤7.0 at Screening Participants with RMS or PMS who fulfil international panel criteria for diagnosis (McDonald 2017 criteria) Participants not treated with any approved MS treatment at Screening and not planning to start on any MS therapy during the study (including follow-up) Female participants must practice abstinence or otherwise use contraception Exclusion Criteria: Evidence of recent clinical disease activity Evidence of recent MRI activity 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 Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, or other major diseases 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 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 History of hypersensitivity to biologic agents or any of the excipients in the formulation Cohorts 5 and 6 and later cohorts, as appropriate: 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 period prior to acquiring any screening laboratory tests but should not be withdrawn from therapies for the sole purpose of meeting eligibility for the trial Previous treatment with alemtuzumab, cladribine, mitoxantrone, cyclophosphamide, total body irradiation, bone marrow transplantation, and hematopoietic stem cell transplantation. For the USA only, previous treatment with daclizumab 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 baseline ± 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 PD or PK half-life (if known), whichever is longer Diagnostic Assessments: Positive result on human immunodeficiency virus (HIV1) and HIV2, hepatitis C, or hepatitis B Participants with suicidal ideation or behavior within 6 months prior to Screening or participants who, in the Investigator's judgment, pose a suicidal or homicidal risk Vaccination with a live or live-attenuated vaccine within 6 weeks prior to Day 1
Sites / Locations
- Stanford University Medical Center; Stanford Neuroscience Health CenterRecruiting
- Yale University Multiple Sclerosis Center
- University of South FloridaRecruiting
- University of Massachusetts Medical School
- UC Health, LLC.Recruiting
- UZ GentRecruiting
- Montreal Neurological Institute and Hospital; Pharmacy DepartmentRecruiting
- Universitätsklinikum "Carl Gustav Carus"; MS Center DresdenRecruiting
- Universitätsmedizin Göttingen Georg-August-Universität; Klinik für NeurologieRecruiting
- Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-ZentrumRecruiting
- Universitätsklinikum Münster Klinik u. Poliklinik f. NeurologieRecruiting
- Hadassah University Hospital - Ein KeremRecruiting
- Tel Aviv Sourasky Medical Center; Department of Neurology
- IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi MultiplaRecruiting
- Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie NeuromuscolariRecruiting
- ARENSIA Exploratory Medicine Phase I, PMSI Republican Clinical HospitalRecruiting
- Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych FazRecruiting
- Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial NeurologicznyRecruiting
- MedPoloniaRecruiting
- Osrodek Badan Klinicznych Euromedis
- Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
- SPSK nr 1; Klinika NeurologiiRecruiting
- Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
- ARENSIA Exploratory Medicine, County Emergency HospitalRecruiting
Arms of the Study
Arm 1
Experimental
RO7121932: Dose Escalation Cohorts 1 to 6
Participants will receive a single IV dose of RO7121932 on treatment Day 1. The planned starting dose of RO7121932 is 7 milligrams (mg) and will be escalated up to 2000 mg. The maximum dose will not exceed 4000 mg. Doses may be repeated, adjusted downwards, or intermediate doses may be investigated based on emerging data.