Multiple Sclerosis Clinical Trial

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

Summary

The primary purpose of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) doses of RO7121932 in participants with multiple sclerosis (MS)

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Expanded Disability Status Scale (EDSS) score ≤7.0 at Screening
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 clinical disease activity as defined by any clinical relapse within 3 months prior to screening, or by >1 clinical relapse within 12 months prior to screening
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 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-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 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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

129

Study ID:

NCT05704361

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 24 Locations for this study

See Locations Near You

Stanford University Medical Center; Stanford Neuroscience Health Center
Stanford California, 94305, United States
Yale University Multiple Sclerosis Center
New Haven Connecticut, 06473, United States
University of South Florida
Tampa Florida, 33612, United States
University of Massachusetts Medical School
Worcester Massachusetts, 01655, United States
UC Health, LLC.
Cincinnati Ohio, 45219, United States
UZ Gent
Gent , 9000, Belgium
Montreal Neurological Institute and Hospital; Pharmacy Department
Montreal Quebec, H3A 2, Canada
Universitätsklinikum "Carl Gustav Carus"; MS Center Dresden
Dresden , 01307, Germany
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Neurologie
Göttingen , 37075, Germany
Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum
München , 81675, Germany
Universitätsklinikum Münster Klinik u. Poliklinik f. Neurologie
Münster , 48149, Germany
Hadassah University Hospital - Ein Kerem
Jerusalem , 91120, Israel
Tel Aviv Sourasky Medical Center; Department of Neurology
Tel Aviv , 64239, Israel
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
Milano Lombardia, 20132, Italy
Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
Milano Lombardia, 20133, Italy
ARENSIA Exploratory Medicine Phase I, PMSI Republican Clinical Hospital
Chisinau , MD-20, Moldova, Republic of
Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz
Gda?sk , 80-21, Poland
Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Neurologiczny
Grudzi?dz , 86-30, Poland
MedPolonia
Poznan , 60-69, Poland
Osrodek Badan Klinicznych Euromedis
Szczecin , 70-11, Poland
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warszawa , 02-95, Poland
SPSK nr 1; Klinika Neurologii
Zabrze , 41-80, Poland
Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
Braga , 4710-, Portugal
ARENSIA Exploratory Medicine, County Emergency Hospital
Cluj-Napoca , 40000, Romania

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

129

Study ID:

NCT05704361

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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