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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05704361
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hoffmann-La Roche
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trials
Principal Investigator Affiliation Hoffmann-La Roche
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Canada, Germany, Israel, Italy, Moldova, Republic of, Poland, Portugal, Romania, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis
Arms & Interventions

Arms

Experimental: 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.

Experimental: 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.

Experimental: 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.

Interventions

Drug: - RO7121932 IV - SAD

Part 1: Participants will receive a single dose of RO7121932 administered as IV infusion.

Drug: - RO7121932 SC - SAD

Part 2: Participants will receive a single dose of RO7121932 administered as SC injection.

Drug: - RO7121932 - MAD

Part 3: Participants will receive multiple doses of RO7121932 administered as SC injections.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford, California

Status

Active, not recruiting

Address

Stanford University Medical Center; Stanford Neuroscience Health Center

Stanford, California, 94305

Site Contact

[email protected]

888-662-6728 (U.S. Only)

New Haven, Connecticut

Status

Recruiting

Address

Yale University Multiple Sclerosis Center

New Haven, Connecticut, 06473

Site Contact

[email protected]

888-662-6728 (U.S. Only)

University of South Florida, Tampa, Florida

Status

Active, not recruiting

Address

University of South Florida

Tampa, Florida, 33612

Site Contact

[email protected]

888-662-6728 (U.S. Only)

Worcester, Massachusetts

Status

Recruiting

Address

University of Massachusetts Medical School

Worcester, Massachusetts, 01655

Site Contact

[email protected]

888-662-6728 (U.S. Only)

UC Health, LLC., Cincinnati, Ohio

Status

Recruiting

Address

UC Health, LLC.

Cincinnati, Ohio, 45219

Site Contact

[email protected]

888-662-6728 (U.S. Only)

International Sites

UZ Gent, Gent, Belgium

Status

Recruiting

Address

UZ Gent

Gent, , 9000

Site Contact

[email protected]

888-662-6728 (U.S. Only)

Montreal, Quebec, Canada

Status

Recruiting

Address

Montreal Neurological Institute and Hospital; Pharmacy Department

Montreal, Quebec, H3A 2B4

Site Contact

[email protected]

888-662-6728 (U.S. Only)

Dresden, Germany

Status

Active, not recruiting

Address

Universitätsklinikum "Carl Gustav Carus"; MS Center Dresden

Dresden, , 01307

Site Contact

[email protected]

888-662-6728 (U.S. Only)

Göttingen, Germany

Status

Recruiting

Address

Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Neurologie

Göttingen, , 37075

Site Contact

[email protected]

888-662-6728 (U.S. Only)

München, Germany

Status

Recruiting

Address

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

München, , 81675

Site Contact

[email protected]

888-662-6728 (U.S. Only)

Münster, Germany

Status

Recruiting

Address

Universitätsklinikum Münster Klinik u. Poliklinik f. Neurologie

Münster, , 48149

Site Contact

[email protected]

888-662-6728 (U.S. Only)

Hadassah University Hospital - Ein Kerem, Jerusalem, Israel

Status

Active, not recruiting

Address

Hadassah University Hospital - Ein Kerem

Jerusalem, , 9112001

Site Contact

[email protected]

888-662-6728 (U.S. Only)

Tel Aviv, Israel

Status

Withdrawn

Address

Tel Aviv Sourasky Medical Center; Department of Neurology

Tel Aviv, , 6423906

Site Contact

[email protected]

888-662-6728 (U.S. Only)

Milano, Lombardia, Italy

Status

Recruiting

Address

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

Milano, Lombardia, 20132

Site Contact

[email protected]

888-662-6728 (U.S. Only)

Milano, Lombardia, Italy

Status

Recruiting

Address

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

Milano, Lombardia, 20133

Site Contact

[email protected]

888-662-6728 (U.S. Only)

Chisinau, Moldova, Republic of

Status

Recruiting

Address

ARENSIA Exploratory Medicine Phase I, PMSI Republican Clinical Hospital

Chisinau, , MD-2025

Site Contact

[email protected]

888-662-6728 (U.S. Only)

Gda?sk, Poland

Status

Withdrawn

Address

Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz

Gda?sk, , 80-214

Site Contact

[email protected]

888-662-6728 (U.S. Only)

Grudzi?dz, Poland

Status

Completed

Address

Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Neurologiczny

Grudzi?dz, , 86-300

Site Contact

[email protected]

888-662-6728 (U.S. Only)

MedPolonia, Poznan, Poland

Status

Recruiting

Address

MedPolonia

Poznan, , 60-693

Site Contact

[email protected]

888-662-6728 (U.S. Only)

Osrodek Badan Klinicznych Euromedis, Szczecin, Poland

Status

Recruiting

Address

Osrodek Badan Klinicznych Euromedis

Szczecin, , 70-111

Site Contact

[email protected]

888-662-6728 (U.S. Only)

Warszawa, Poland

Status

Withdrawn

Address

Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

Warszawa, , 02-957

Site Contact

[email protected]

888-662-6728 (U.S. Only)

SPSK nr 1; Klinika Neurologii, Zabrze, Poland

Status

Recruiting

Address

SPSK nr 1; Klinika Neurologii

Zabrze, , 41-800

Site Contact

[email protected]

888-662-6728 (U.S. Only)

Braga, Portugal

Status

Recruiting

Address

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

Braga, , 4710-243

Site Contact

[email protected]

888-662-6728 (U.S. Only)

Cluj-Napoca, Romania

Status

Recruiting

Address

ARENSIA Exploratory Medicine, County Emergency Hospital

Cluj-Napoca, , 400006

Site Contact

[email protected]

888-662-6728 (U.S. Only)

Resources

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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