Phase
Condition
Memory Loss
Neurologic Disorders
Scar Tissue
Treatment
RO7121932
RO7121932 IV - SAD
RO7121932 SC - SAD
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Expanded Disability Status Scale (EDSS) score ≤7.0 at Screening
Participants with relapsing multiple sclerosis (RMS) or progressive multiplesclerosis (PMS) who fulfil international panel criteria for diagnosis (McDonald 2017criteria)
Participants not treated with any approved MS treatment at Screening and notplanning to start on any MS therapy during the study (including follow-up)
Female participants must practice abstinence or otherwise use contraception
Exclusion
Exclusion Criteria:
Evidence of clinical disease activity as defined by any clinical relapse within 3months prior to screening, or by >1 clinical relapse within 12 months prior toscreening
Evidence of magnetic resonance imaging (MRI) activity as defined by the presence of ≥ 1 Gadolinium-enhancing T1 lesion in the screening MRI scan or by ≥ 4 new orenlarging T2 lesions in the screening scan as compared to a reference scan
Participants who have active progressive multifocal leukoencephalopathy (PML), havehad confirmed PML, or have a high degree of suspicion for PML
Known presence of other neurological disorders that may mimic MS including but notlimited to: neuromyelitis optica spectrum disease, Lyme disease, untreated VitaminB12 deficiency, neurosarcoidosis, cerebrovascular disorders, and untreatedhypothyroidism
Known active or uncontrolled bacterial, viral, fungal, mycobacterial infection orother infection, excluding fungal infection of nail beds, including participantsexhibiting 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 10years of screening. Basal or squamous cell carcinoma of the skin that has beenexcised and is considered cured and in situ carcinoma of the cervix treated withapparent success by curative therapy >1 year prior to screening is not exclusionary
Any concomitant disease that may require treatment with systemic corticosteroids orimmunosuppressants 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 theformulation
Only for cohorts where CSF samples are planned to be collected: Participants with ahistory of spinal cord compression, raised intra-cerebral pressure, clinicallysignificant vertebral joint pathology or any other current abnormalities in thelumbar region which could prevent the lumbar puncture procedure.
Prior/Concomitant Therapy:
Treatment with any approved MS treatment at Screening. Participants may becomeeligible after completion of a washout period prior to acquiring any screeninglaboratory tests but should not be withdrawn from therapies for the sole purpose ofmeeting eligibility for the trial
Previous treatment with RO7121932, alemtuzumab, cladribine, mitoxantrone,cyclophosphamide, total body irradiation, bone marrow transplantation, andhematopoietic stem cell transplantation. For the USA only, previous treatment withdaclizumab
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 areoutside the normal range, or not back to individual baseline ± 20% (if data areavailable),
If discontinuation of a prior B-cell depletion therapy was motivated by safetyreasons
Current or prior treatment with natalizumab (if <24 months prior to acquiring anyscreening laboratory tests)
Prior/Concurrent Clinical Study Experience:
- Participation in an investigational drug medicinal product or medical device studywithin 30 days before Screening or within five times the pharmacodynamic (PD) orpharmacokinetic (PK) half-life (if known), whichever is longer
Diagnostic Assessments:
Positive result on human immunodeficiency virus (HIV1) and HIV2, hepatitis C, orhepatitis B
Participants with suicidal ideation or behavior within 6 months prior to Screeningor participants who, in the Investigator's judgment, pose a suicidal or homicidalrisk
Vaccination with a live or live-attenuated vaccine within 6 weeks prior to Day 1
Study Design
Connect with a study center
Cliniques Universitaires St-Luc
Bruxelles, 1200
BelgiumActive - Recruiting
UZ Gent
Gent, 9000
BelgiumActive - Recruiting
Montreal Neurological Institute and Hospital
Montreal, Quebec H3A 2B4
CanadaActive - Recruiting
Montreal Neurological Institute and Hospital; Pharmacy Department
Montreal, Quebec H3A 2B4
CanadaActive - Recruiting
Universitätsklinikum "Carl Gustav Carus"
Dresden, 01307
GermanySite Not Available
Universitätsklinikum "Carl Gustav Carus"; MS Center Dresden
Dresden, 01307
GermanySite Not Available
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, 37075
GermanyCompleted
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Neurologie
Göttingen, 37075
GermanyActive - Recruiting
Klinikum rechts der Isar der TU Muenchen
München, 81675
GermanyActive - Recruiting
Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum
München, 81675
GermanyActive - Recruiting
Universitätsklinikum Münster Klinik u. Poliklinik f. Neurologie
Münster, 48149
GermanyActive - Recruiting
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, 72076
GermanyActive - Recruiting
Universitätsklinikum Ulm
Ulm, 89081
GermanyActive - Recruiting
Hadassah University Hospital - Ein Kerem
Jerusalem, 9112001
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
IsraelSite Not Available
Tel Aviv Sourasky Medical Center; Department of Neurology
Tel Aviv, 6423906
IsraelSite Not Available
Fond. Istituto Neurologico C.Besta
Milano, Lombardia 20133
ItalyActive - Recruiting
Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
Milano, Lombardia 20133
ItalyActive - Recruiting
IRCCS Ospedale San Raffaele
Milano, Lombardia 20132
ItalyActive - Recruiting
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
Milano, Lombardia 20132
ItalyActive - Recruiting
ARENSIA Exploratory Medicine Phase I, PMSI Republican Clinical Hospital
Chisinau, MD-2025
Moldova, Republic ofActive - Recruiting
Uniwersyteckie Centrum Kliniczne
Gda?sk, 80-214
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz
Gda?sk, 80-214
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz
Gdańsk, 80-214
PolandSite Not Available
Regionalny Szpital Specjalistyczny im. W. Bieganskiego
Grudzi?dz, 86-300
PolandCompleted
Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Neurologiczny
Grudzi?dz, 86-300
PolandCompleted
Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Neurologiczny
Grudziądz, 86-300
PolandSite Not Available
MedPolonia
Poznan, 60-693
PolandSite Not Available
Osrodek Badan Klinicznych Euromedis
Szczecin, 70-111
PolandActive - Recruiting
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warszawa, 02-957
PolandSite Not Available
SPSK nr 1
Zabrze, 41-800
PolandActive - Recruiting
SPSK nr 1; Klinika Neurologii
Zabrze, 41-800
PolandActive - Recruiting
Hospital de Braga
Braga, 4710-243
PortugalActive - Recruiting
Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
Braga, 4710-243
PortugalActive - Recruiting
Hospital Santo Antonio dos Capuchos
Lisboa, 1169-050
PortugalActive - Recruiting
Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião
Santa Maria Da Feira, 4520-211
PortugalActive - Recruiting
ARENSIA Exploratory Medicine SRL - Bucharest (Monza Medical Center)
Bucharest, 011658
RomaniaActive - Recruiting
Arensia Clinics S.R.L.
Bucuresti, 011658
RomaniaSite Not Available
Monza Medical Center
Bucuresti, 011658
RomaniaActive - Recruiting
ARENSIA Exploratory Medicine, County Emergency Hospital
Cluj Napoca, 40006
RomaniaActive - Recruiting
ARENSIA Exploratory Medicine, County Emergency Hospital
Cluj-Napoca, 400006
RomaniaSite Not Available
University Clinical Center of Serbia
Belgrade, 11000
SerbiaActive - Recruiting
Hospital Universitari Vall dHebron (CEMCAT)
Barcelona, 08035
SpainActive - Recruiting
Stanford University Medical Center
Stanford, California 94305
United StatesCompleted
Stanford University Medical Center; Stanford Neuroscience Health Center
Stanford, California 94305
United StatesSite Not Available
Yale University Multiple Sclerosis Center
New Haven, Connecticut 06473
United StatesCompleted
University of South Florida
Tampa, Florida 33612
United StatesSite Not Available
University of Massachusetts Medical School
Worcester, Massachusetts 01655
United StatesSite Not Available
UC Health, LLC.
Cincinnati, Ohio 45267
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.