A Multiple-center, Non-randomized, Open-label, Adaptive, Single-ascending Dose (Part 1 and Part 2) and Multiple-ascending Dose (Part 3) Parallel, Phase IB Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of RO7121932 Following Intravenous (Parts 1) and Subcutaneous Administration (Parts 2 and 3) in Participants With Multiple Sclerosis
Status: Recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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) of RO7121932 in participants with multiple sclerosis (MS).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Stanford University Medical Center
COMPLETED
Stanford
Connecticut
Yale University Multiple Sclerosis Center
COMPLETED
New Haven
Florida
University of South Florida
WITHDRAWN
Tampa
Massachusetts
University of Massachusetts Medical School
WITHDRAWN
Worcester
Ohio
UC Health, LLC.
WITHDRAWN
Cincinnati
Other Locations
Belgium
Cliniques Universitaires St-Luc
RECRUITING
Brussels
UZ Gent
RECRUITING
Ghent
Canada
Montreal Neurological Institute and Hospital
RECRUITING
Montreal
Germany
Universitätsklinikum Carl Gustav Carus
ACTIVE_NOT_RECRUITING
Dresden
Universitätsmedizin Göttingen Georg-August-Universität
COMPLETED
Göttingen
Klinikum rechts der Isar der TU Muenchen
COMPLETED
München
Universitätsklinikum Münster Klinik u. Poliklinik f. Neurologie
RECRUITING
Münster
Universitätsklinikum Tübingen, Zentrum für Neurologie
RECRUITING
Tübingen
Universitätsklinikum Ulm
RECRUITING
Ulm
Israel
Hadassah University Hospital - Ein Kerem
RECRUITING
Jerusalem
Tel Aviv Sourasky Medical Center
WITHDRAWN
Tel Aviv
Italy
Fond. Istituto Neurologico C.Besta
RECRUITING
Milan
IRCCS Ospedale San Raffaele
RECRUITING
Milan
Poland
Uniwersyteckie Centrum Kliniczne
WITHDRAWN
Gda?sk
Regionalny Szpital Specjalistyczny im. W. Bieganskiego
COMPLETED
Grudzi?dz
MedPolonia
RECRUITING
Poznan
Osrodek Badan Klinicznych Euromedis
RECRUITING
Szczecin
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
WITHDRAWN
Warsaw
SPSK nr 1
RECRUITING
Zabrze
Portugal
Hospital de Braga
RECRUITING
Braga
Hospital Santo Antonio dos Capuchos
RECRUITING
Lisbon
Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião
RECRUITING
Santa Maria Da Feira
Republic of Moldova
ARENSIA Exploratory Medicine Phase I, PMSI Republican Clinical Hospital
RECRUITING
Chisinau
Romania
ARENSIA Exploratory Medicine SRL - Bucharest (Monza Medical Center)
RECRUITING
Bucharest
ARENSIA Exploratory Medicine, County Emergency Hospital
RECRUITING
Cluj-napoca
Serbia
University Clinical Center of Serbia
RECRUITING
Belgrade
Spain
Hospital Universitari Vall dHebron (CEMCAT)
RECRUITING
Barcelona
Contact Information
Primary
Reference Study ID Number: BP42230 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date: 2021-08-11
Estimated Completion Date: 2027-07-08
Participants
Target number of participants: 129
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche