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Also known as RO7121932 IV
RO7121932 · 1 trial · 1 indication
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) IV: RO7121932- Dose Escalation Cohorts 1 to 7 | EXPERIMENTAL | 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. |
| Part 2: SAD SC: RO7121932- Dose Escalation Cohorts 1 to 2 | EXPERIMENTAL | 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. |
| Part 3: Multiple Ascending Dose (MAD) SC: RO7121932- Dose Escalation Cohorts 1 to 3 | EXPERIMENTAL | 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. |
| Part 4: Long-term Safety: RO7121932- Dose Escalation Cohorts 1 to 2 | EXPERIMENTAL | Participants will receive a single IV dose of RO7121932 on treatment Day 1 followed by multiple SC maintenance doses of RO7121932. Doses may be repeated, adjusted downwards, or intermediate doses may be investigated based on emerging data. |
| Name | Type | Description |
|---|---|---|
| RO7121932 IV | DRUG | Participants will receive RO7121932, as an IV infusion, per the schedule specified in the treatment arms. |
| RO7121932 SC | DRUG | Participants will receive RO7121932, as SC injection, per the schedule specified in the treatment arms. |
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 app...
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RO7121932 is an investigational small molecule being developed by Roche Holding AG for multiple sclerosis, a neurological disease. It is in Phase 1 clinical development and has not been approved by any regulatory authority. It is administered both intravenously and subcutaneously in clinical study settings.
RO7121932 is being studied as a treatment for multiple sclerosis. It is an investigational therapy in Phase 1 development, so it is not yet available as a prescribed treatment. The ongoing study enrolls adults with multiple sclerosis to evaluate safety, tolerability, and how the body processes the drug.
RO7121932 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is running the clinical development program for the drug in multiple sclerosis, including a Phase 1 study conducted across sites in the United States, Europe, Canada, and Israel.
RO7121932 is in Phase 1 clinical development. It is an investigational drug and is not FDA approved. The Phase 1 program is designed to assess safety, tolerability, and how the body processes the drug in participants with multiple sclerosis.
RO7121932 is being evaluated in one active clinical trial, NCT05704361, titled a study to investigate the safety, tolerability, and processing by the body of intravenous and subcutaneous RO7121932 administration in participants with multiple sclerosis. The trial is active but not recruiting, with an enrollment of 119 participants across multiple countries.
Yes, RO7121932 IV is an alternative name for RO7121932. The intravenous formulation is one of the routes being tested in the Phase 1 trial, which also evaluates subcutaneous administration. Both refer to the same investigational small molecule developed by Roche for multiple sclerosis.