A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis
NCT ID: NCT05704361
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
129 participants
INTERVENTIONAL
2021-08-11
2027-07-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Single Ascending Dose (SAD) IV: RO7121932- Dose Escalation Cohorts 1 to 6 and Later Cohorts
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.
RO7121932 IV
Participants will receive RO7121932, as an IV infusion, per the schedule specified in the treatment arms.
Part 2: SAD SC: RO7121932- Dose Escalation Cohorts 1 to 2
Participants will receive a single SC dose of RO7121932 on treatment Day 1. The planned starting dose of RO7121932 is 70 mg and will be escalated up to 200 mg. Doses may be repeated, adjusted downwards, or intermediate doses may be investigated based on emerging data.
RO7121932 SC
Participants will receive RO7121932, as SC injection, per the schedule specified in the treatment arms.
Part 3: Multiple Ascending Dose (MAD) SC: RO7121932- Dose Escalation Cohorts 1 to 3
Participants will receive multiple SC doses of RO7121932, once weekly on treatment Day 1 through Day 22. The planned starting dose of RO7121932 is 70 mg and will be escalated up to 700 mg. Doses may be repeated, adjusted downwards, or intermediate doses may be investigated based on emerging data.
RO7121932 SC
Participants will receive RO7121932, as SC injection, per the schedule specified in the treatment arms.
Interventions
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RO7121932 IV
Participants will receive RO7121932, as an IV infusion, per the schedule specified in the treatment arms.
RO7121932 SC
Participants will receive RO7121932, as SC injection, per the schedule specified in the treatment arms.
Eligibility Criteria
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Inclusion Criteria
* Participants with relapsing multiple sclerosis (RMS) or progressive multiple sclerosis (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 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
* 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
* Only for cohorts 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 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 RO7121932, 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-cluster of differentiation 20 (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 pharmacodynamic (PD) or pharmacokinetic (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 SI 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
18 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Stanford University Medical Center
Stanford, California, United States
Yale University Multiple Sclerosis Center
New Haven, Connecticut, United States
University of South Florida
Tampa, Florida, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
UC Health, LLC.
Cincinnati, Ohio, United States
Cliniques Universitaires St-Luc
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
Universitätsklinikum "Carl Gustav Carus"
Dresden, , Germany
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, , Germany
Klinikum rechts der Isar der TU Muenchen
München, , Germany
Universitätsklinikum Münster Klinik u. Poliklinik f. Neurologie
Münster, , Germany
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy
Fond. Istituto Neurologico C.Besta
Milan, Lombardy, Italy
ARENSIA Exploratory Medicine Phase I, PMSI Republican Clinical Hospital
Chisinau, , Moldova
Uniwersyteckie Centrum Kliniczne
Gda?sk, , Poland
Regionalny Szpital Specjalistyczny im. W. Bieganskiego
Grudzi?dz, , Poland
MedPolonia
Poznan, , Poland
Osrodek Badan Klinicznych Euromedis
Szczecin, , Poland
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warsaw, , Poland
SPSK nr 1
Zabrze, , Poland
Hospital de Braga
Braga, , Portugal
Hospital Santo Antonio dos Capuchos
Lisbon, , Portugal
Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião
Santa Maria da Feira, , Portugal
ARENSIA Exploratory Medicine SRL - Bucharest (Monza Medical Center)
Bucharest, , Romania
ARENSIA Exploratory Medicine, County Emergency Hospital
Cluj-Napoca, , Romania
University Clinical Center of Serbia
Belgrade, , Serbia
Hospital Universitari Vall dHebron (CEMCAT)
Barcelona, , Spain
Countries
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Central Contacts
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Reference Study ID Number: BP42230 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. Only)
Email: [email protected]
Other Identifiers
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2020-004122-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-509357-31-00
Identifier Type: CTIS
Identifier Source: secondary_id
BP42230
Identifier Type: -
Identifier Source: org_study_id