A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis
Condition(s) studied
Investigational drug(s) / intervention(s)
RO7121932 IV: Participants will receive RO7121932, as an IV infusion, per the schedule specified in the treatment arms.
RO7121932 SC: Participants will receive RO7121932, as SC injection, per the schedule specified in the treatment arms.
Study 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
Primary outcome measure(s)
- Parts 1, 2, 3, and 4: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) With Severity of AEs Measured According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE V5) — Day 1 to Day 169 for Part 1 and Part 2; Day 1 to Day 197 for Part 3; Day 1 to Day 253 for Part 4
- Parts 1, 2, 3, and 4: Change From Baseline in Suicide Risk as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS) — Day 1 to Day 169 for Part 1 and Part 2; Day 1 to Day 197 for Part 3; Day 1 to Day 253 for Part 4
The C-SSRS is an interview-based instrument used to assess baseline incidence of suicidal ideation (SI) and behavior. The assessment includes "yes" or "no" responses for 5 questions, each related to SI (wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent, active SI with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings are provided for severity of ideation (if present), from 0 to 5. A score of 0 is assigned if no suicide risk is present. A score of 1 or higher indicates SI or behavior, with 5 being the most severe. - Parts 2 and 3: Percentage of Participants With Local Pain at the Site of Injection Assessed Using the Visual Analog Scale (VAS) — Day 1, 2, 5, 8 for Part 2; Day 1, 2, 5, 8, 15, 22, 29, 36 for Part 3
VAS is a 100 millimetre (mm) horizontal visual analog scale with values 0 to 100 mm to indicate pain. The following cutpoints on the VAS will be considered in the interpretation of the pain data: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). A higher score indicates greater pain intensity. - Parts 2 and 3: Percentage of Participants With Local Injection-site Reaction Using Local Injection-site Symptom Assessment (LISSA) — Day 1,2, 5, 8 for Part 2; Day 1, 2, 5, 8, 15, 22, 29, 36 for Part 3
LISSA form will be used to assess the participant's injection site for the following categories of reactions: Burning, Itching, Bruising, Erythema (redness), Hive formation, Induration, Swelling, Ecchymosis, Sensitivity, Papules, Stinging, Blister, Cold sensation, and Other. These reactions will be described using the following scale: Unable to assess, less than a dime (\<18 mm/\<0.7 inches), a dime (18 mm/0.7 inches), a nickel (21 mm/0.8 inches), a quarter (24 mm/1 inch), a half dollar (31 mm/1.2 inches), larger than a half dollar (\>31 mm/\>1.2 inches). A higher score indicates high injection site reactions. - Part 4: Percentage of Participants With Local Injection-site Reactions — Day 1 to Day 253
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| Stanford University Medical Center | Stanford | California | |
| Yale University Multiple Sclerosis Center | New Haven | Connecticut | |
| Cliniques Universitaires St-Luc | Brussels | Belgium | |
| UZ Gent | Ghent | Belgium | |
| Montreal Neurological Institute and Hospital | Montreal | Quebec | |
| 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 | |
| IRCCS Ospedale San Raffaele | Milan | Lombardy | |
| Fond. Istituto Neurologico C.Besta | Milan | Lombardy | |
| ARENSIA Exploratory Medicine Phase I, PMSI Republican Clinical Hospital | Chisinau | Moldova | |
| Regionalny Szpital Specjalistyczny im. W. Bieganskiego | Grudzi?dz | Poland | |
| MedPolonia | Poznan | Poland | |
| Osrodek Badan Klinicznych Euromedis | Szczecin | 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 |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05704361 on ClinicalTrials.gov ↗ ← All trials in Italy