RO7121932 IV
DrugParticipants will receive RO7121932, as an IV infusion, per the schedule specified in the treatment arms.
NCT Number: NCT05704361
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 1
Cliniques Universitaires St-Luc, Brussels, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prior/Concomitant Therapy:
Prior/Concurrent Clinical Study Experience:
Diagnostic Assessments:
Participants will receive RO7121932, as an IV infusion, per the schedule specified in the treatment arms.
Participants will receive RO7121932, as SC injection, per the schedule specified in the treatment arms.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 to Day 253
Time frame: Day 1 to Day 169 for Part 1 and Part 2; Days 1, 2, 5 and, 22 for Part 3
Time frame: Day 1 to Day 169 for Part 1 and Part 2; Days 1, 2, 5 and, 22 for Part 3
Time frame: Day 1 (predose) to Day 8 (168 hours post-dose) for Parts 1, 2, and 3 (Week 1) and Day 22 (predose) to Day 29 (168 hours post-dose) for Part 3 (Week 4)
Time frame: Day 1 to Day 169 for Part 1 and Part 2
Time frame: Day 1 to Day 169 for Part 1 and Part 2
Time frame: Day 1 to Day 169
Time frame: Day 1 to Day 169 for Part 2; Day 22 to Day 29 for Part 3
Time frame: Day 1 to Day 169 for Part 1 and Part 2; Day 22 to Day 197 for Part 3
Time frame: Day 1 to Day 169 for Part 1 and Part 2; Day 22 to Day 197 for Part 3
Time frame: Day 1 to Day 197
Time frame: Day 1, 2, 5 and 22
Time frame: Day 1 to Day 253
Time frame: Screening, Day 2 to Day 169 for Part 1; Screening, Day 2 to Day 197 for Part 3; Screening, Day 85 and Day 169 for Part 4
Time frame: Days 1, 8, 22, 29, 57, 85,169 for Part 1; Days 1, 8, 22, 57, 85, 169 for Part 2; Days 1, 8, 15, 22, 29, 57, 85, 120 & 197 for Part 3; Days 1 to 253 for Part 4
Time frame: Screening, Days 1, 2, 8, 22, 57, 85, 169 for Part 1; Screening, Days 1, 2, 8, 22, 57, 85, 169 for Part 2; Screening, Days 1, 2, 8, 15, 22, 57, 85, 120, 197 for Part 3; Screening up to Day 253 for Part 4
Time frame: Screening, Day 2 to 169; Screening, Day 85 and Day 169 for Part 4
Time frame: Screening, Days 1, 2, 8, 22, 57, 85, 169 for Part 1; Screening, Days 1, 2, 8, 22, 57, 85, 169 for Part 2; Screening, Days 1, 2, 8, 15, 22, 57, 85, 120, 197 for Part 3; Screening up to Day 253 for Part 4
Time frame: Screening, Day 2 to 169 for Part 1; Screening, Day 2 to 197 for Part 3; Screening, Day 85 and Day 169 for Part 4
Contact information is provided by the study sponsor or research team.
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
Reference Study ID Number: BP42230 https://forpatients.roche.com/ No attachments to email below.
CONTACT
888-662-6728 (U.S. Only)
Hoffmann-La Roche
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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