Actively Recruiting
A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis
Led by Hoffmann-La Roche · Updated on 2026-04-27
129
Participants Needed
32
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary purpose of the study is to evaluate the safety and tolerability of a single-ascending intravenous (IV) dose (Part 1), a single-ascending subcutaneous (SC) dose (Part 2), and multiple ascending SC doses (Part 3) of RO7121932 in participants with multiple sclerosis (MS).
CONDITIONS
Official Title
A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Expanded Disability Status Scale (EDSS) score �37.0 at Screening
- Diagnosis of relapsing or progressive multiple sclerosis according to McDonald 2017 criteria
- Not currently treated with any approved MS therapy and no plans to start during the study
- Female participants must use contraception or practice abstinence
You will not qualify if you...
- Clinical relapse within 3 months or more than 1 relapse within 12 months prior to screening
- MRI showing �37 1 Gadolinium-enhancing T1 lesion or �4 new or enlarging T2 lesions at screening
- Active or suspected progressive multifocal leukoencephalopathy (PML)
- Other neurological disorders mimicking MS such as neuromyelitis optica, Lyme disease, untreated Vitamin B12 deficiency, neurosarcoidosis, cerebrovascular disorders, untreated hypothyroidism
- Active or uncontrolled infections including recent symptoms of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
- Current diagnosis of epilepsy
- Major diseases affecting heart, metabolism, blood, liver, immune system, urinary, endocrine, nervous, lung, psychiatric, skin, allergy, kidney, or other major systems
- Cancer history within 10 years except cured skin basal/squamous cell carcinoma or treated cervical carcinoma
- Need for systemic corticosteroids or immunosuppressants during the study
- History of active primary or secondary immunodeficiency
- Hypersensitivity to biologic agents or excipients
- For lumbar puncture cohorts: spinal cord compression, raised brain pressure, vertebral joint problems or lumbar abnormalities preventing lumbar puncture
- Prior treatments including RO7121932, alemtuzumab, cladribine, mitoxantrone, cyclophosphamide, total body irradiation, bone marrow or stem cell transplant, certain anti-CD20 therapies within specified timeframes, natalizumab within 24 months
- Participation in other investigational drug or device studies within 30 days or longer depending on drug half-life
- Positive tests for HIV, hepatitis B or C
- Suicidal or homicidal risk within 6 months prior to screening
- Vaccination with live or live-attenuated vaccine within 6 weeks prior to Day 1
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
Stanford University Medical Center
Stanford, California, United States, 94305
Completed
2
Yale University Multiple Sclerosis Center
New Haven, Connecticut, United States, 06473
Completed
3
University of South Florida
Tampa, Florida, United States, 33612
Withdrawn
4
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Withdrawn
5
UC Health, LLC.
Cincinnati, Ohio, United States, 45267
Withdrawn
6
Cliniques Universitaires St-Luc
Brussels, Belgium, 1200
Actively Recruiting
7
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
8
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada, H3A 2B4
Actively Recruiting
9
Universitätsklinikum "Carl Gustav Carus"
Dresden, Germany, 01307
Active, Not Recruiting
10
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, Germany, 37075
Completed
11
Klinikum rechts der Isar der TU Muenchen
München, Germany, 81675
Completed
12
Universitätsklinikum Münster Klinik u. Poliklinik f. Neurologie
Münster, Germany, 48149
Actively Recruiting
13
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, Germany, 72076
Actively Recruiting
14
Universitätsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
15
Hadassah University Hospital - Ein Kerem
Jerusalem, Israel, 9112001
Actively Recruiting
16
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Withdrawn
17
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy, 20132
Actively Recruiting
18
Fond. Istituto Neurologico C.Besta
Milan, Lombardy, Italy, 20133
Actively Recruiting
19
ARENSIA Exploratory Medicine Phase I, PMSI Republican Clinical Hospital
Chisinau, Moldova, MD-2025
Completed
20
Uniwersyteckie Centrum Kliniczne
Gda?sk, Poland, 80-214
Withdrawn
21
Regionalny Szpital Specjalistyczny im. W. Bieganskiego
Grudzi?dz, Poland, 86-300
Completed
22
MedPolonia
Poznan, Poland, 60-693
Actively Recruiting
23
Osrodek Badan Klinicznych Euromedis
Szczecin, Poland, 70-111
Actively Recruiting
24
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warsaw, Poland, 02-957
Withdrawn
25
SPSK nr 1
Zabrze, Poland, 41-800
Completed
26
Hospital de Braga
Braga, Portugal, 4710-243
Actively Recruiting
27
Hospital Santo Antonio dos Capuchos
Lisbon, Portugal, 1169-050
Actively Recruiting
28
Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião
Santa Maria da Feira, Portugal, 4520-211
Actively Recruiting
29
ARENSIA Exploratory Medicine SRL - Bucharest (Monza Medical Center)
Bucharest, Romania, 011658
Actively Recruiting
30
ARENSIA Exploratory Medicine, County Emergency Hospital
Cluj-Napoca, Romania, 40006
Actively Recruiting
31
University Clinical Center of Serbia
Belgrade, Serbia, 11000
Actively Recruiting
32
Hospital Universitari Vall dHebron (CEMCAT)
Barcelona, Spain, 08035
Actively Recruiting
Research Team
R
Reference Study ID Number: BP42230 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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