A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 in Participants With Multiple Sclerosis.

Last updated: May 12, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

1

Condition

Memory Loss

Neurologic Disorders

Scar Tissue

Treatment

RO7121932

RO7121932 IV - SAD

RO7121932 SC - SAD

Clinical Study ID

NCT05704361
BP42230
2020-004122-33
  • Ages 18-65
  • All Genders

Study Summary

The primary purpose of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) (Part 1) and subcutaneous (SC) (Part 2) doses of RO7121932 and multiple ascending SC (Part 3) doses of RO7121932 in participants with multiple sclerosis (MS).

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

Total Participants: 129
Treatment Group(s): 4
Primary Treatment: RO7121932
Phase: 1
Study Start date:
August 11, 2021
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Cliniques Universitaires St-Luc

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec H3A 2B4
    Canada

    Active - Recruiting

  • Montreal Neurological Institute and Hospital; Pharmacy Department

    Montreal, Quebec H3A 2B4
    Canada

    Active - Recruiting

  • Universitätsklinikum "Carl Gustav Carus"

    Dresden, 01307
    Germany

    Site Not Available

  • Universitätsklinikum "Carl Gustav Carus"; MS Center Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Universitätsmedizin Göttingen Georg-August-Universität

    Göttingen, 37075
    Germany

    Completed

  • Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Neurologie

    Göttingen, 37075
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar der TU Muenchen

    München, 81675
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum

    München, 81675
    Germany

    Active - Recruiting

  • Universitätsklinikum Münster Klinik u. Poliklinik f. Neurologie

    Münster, 48149
    Germany

    Active - Recruiting

  • Universitätsklinikum Tübingen, Zentrum für Neurologie

    Tübingen, 72076
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm

    Ulm, 89081
    Germany

    Active - Recruiting

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center; Department of Neurology

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Fond. Istituto Neurologico C.Besta

    Milano, Lombardia 20133
    Italy

    Active - Recruiting

  • Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

    Milano, Lombardia 20133
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele

    Milano, Lombardia 20132
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

    Milano, Lombardia 20132
    Italy

    Active - Recruiting

  • ARENSIA Exploratory Medicine Phase I, PMSI Republican Clinical Hospital

    Chisinau, MD-2025
    Moldova, Republic of

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz

    Gda?sk, 80-214
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz

    Gdańsk, 80-214
    Poland

    Site Not Available

  • Regionalny Szpital Specjalistyczny im. W. Bieganskiego

    Grudzi?dz, 86-300
    Poland

    Completed

  • Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Neurologiczny

    Grudzi?dz, 86-300
    Poland

    Completed

  • Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Neurologiczny

    Grudziądz, 86-300
    Poland

    Site Not Available

  • MedPolonia

    Poznan, 60-693
    Poland

    Site Not Available

  • Osrodek Badan Klinicznych Euromedis

    Szczecin, 70-111
    Poland

    Active - Recruiting

  • Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

    Warszawa, 02-957
    Poland

    Site Not Available

  • SPSK nr 1

    Zabrze, 41-800
    Poland

    Active - Recruiting

  • SPSK nr 1; Klinika Neurologii

    Zabrze, 41-800
    Poland

    Active - Recruiting

  • Hospital de Braga

    Braga, 4710-243
    Portugal

    Active - Recruiting

  • Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)

    Braga, 4710-243
    Portugal

    Active - Recruiting

  • Hospital Santo Antonio dos Capuchos

    Lisboa, 1169-050
    Portugal

    Active - Recruiting

  • Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião

    Santa Maria Da Feira, 4520-211
    Portugal

    Active - Recruiting

  • ARENSIA Exploratory Medicine SRL - Bucharest (Monza Medical Center)

    Bucharest, 011658
    Romania

    Active - Recruiting

  • Arensia Clinics S.R.L.

    Bucuresti, 011658
    Romania

    Site Not Available

  • Monza Medical Center

    Bucuresti, 011658
    Romania

    Active - Recruiting

  • ARENSIA Exploratory Medicine, County Emergency Hospital

    Cluj Napoca, 40006
    Romania

    Active - Recruiting

  • ARENSIA Exploratory Medicine, County Emergency Hospital

    Cluj-Napoca, 400006
    Romania

    Site Not Available

  • University Clinical Center of Serbia

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • Hospital Universitari Vall dHebron (CEMCAT)

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Completed

  • Stanford University Medical Center; Stanford Neuroscience Health Center

    Stanford, California 94305
    United States

    Site Not Available

  • Yale University Multiple Sclerosis Center

    New Haven, Connecticut 06473
    United States

    Completed

  • University of South Florida

    Tampa, Florida 33612
    United States

    Site Not Available

  • University of Massachusetts Medical School

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • UC Health, LLC.

    Cincinnati, Ohio 45267
    United States

    Site 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.