RecruitingPhase 1NCT05704361

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

A Multiple-center, Non-randomized, Open-label, Adaptive, Single-ascending Dose (Part 1 and Part 2) and Multiple-ascending Dose (Part 3), and Long-term Safety (Part 4), Parallel, Phase IB Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of RO7121932 Following Intravenous (Parts 1 and 4) and Subcutaneous (Parts 2, 3 and 4) Administration in Participants With Multiple Sclerosis

Sponsor

Hoffmann-La Roche

Enrollment

119 participants

Start Date

Aug 11, 2021

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis

Summary

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), and multiple-ascending SC doses following a single IV dose (Part 4) of RO7121932 in participants with multiple sclerosis (MS). Only Parts 1 and 2 of the study will be conducted in the United States, whereas Parts 1, 2, 3, and 4 will be conducted in all other participating countries outside the United States.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new experimental drug called RO7121932, given either by vein (IV) or by injection under the skin, in people with multiple sclerosis (MS). The study is primarily looking at how safely the body processes the drug and what doses are appropriate. **You may be eligible if...** - You have a diagnosis of relapsing MS or progressive MS meeting international criteria - Your disability level on a standard MS scale is 7.0 or below - You are not currently on any approved MS treatment - You are willing to use contraception if you can become pregnant **You may NOT be eligible if...** - You have had a clinical relapse in the past 3 months, or more than one relapse in the past year - Your recent brain MRI shows active disease (new lesions or enhancement) - You have active PML (a serious brain infection) - You have another neurological condition that could be confused with MS - You have an active, uncontrolled infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRO7121932 IV

Participants will receive RO7121932, as an IV infusion, per the schedule specified in the treatment arms.

DRUGRO7121932 SC

Participants will receive RO7121932, as SC injection, per the schedule specified in the treatment arms.

Locations(32)

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

View Full Details on ClinicalTrials.gov

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