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Study of RO7121932 for Multiple Sclerosis

This study is looking at a new treatment called RO7121932 for people with multiple sclerosis (MS). Researchers want to understand how safe RO7121932 is and how your body processes it when given through a vein (intravenous or IV) or as an injection under the skin (subcutaneous or SC). The study will look for any side effects and how severe they are. You may be able to join if you are 18 to 65 years old, have relapsing or progressive MS, and have not been treated with other MS medications recently. The study aims to enroll 129 participants.

Study design
This interventional study is testing different ways to give RO7121932 (IV and SC) and different doses. The phase of the study is not specified, and it plans to enroll 129 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for up to 169 days in Parts 1 and 2, and up to 197 days in Part 3.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05704361

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

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Hoffmann-La Roche
~119 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:RO7121932 IVRO7121932 SC

At a glance

Recruiting sites
18 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over 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
+4 more outcomes measured

Conditions

Multiple Sclerosis

Explore related trials

Multiple Sclerosis

Where it's being run

32 sites across 16 states
Germany6
Poland6
Portugal3
Belgium2
Israel2
Lombardy2
Romania2
California1

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: BP42230 https://forpatients.roche.com/ No attachments to email below.
[email protected]
888-662-6728 (U.S. Only)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)
Biological male and female participants
Female participants must practice abstinence or otherwise use contraception

Exclusion

Evidence of clinical disease activity as defined by any clinical relapse within 3 months prior to screening, or by \>1 clinical relapse within 12 months prior to screening
Evidence of brain magnetic resonance imaging (MRI) activity as defined by the presence of ≥ 1 Gadolinium (Gd)-enhancing T1 lesion in the screening MRI scan or by ≥ 4 new or enlarging T2 lesions in the screening scan as compared to a reference scan
Participants who have active progressive multifocal leukoencephalopathy (PML), have had confirmed PML, or have a high degree of suspicion for PML
Known presence of other neurological disorders that may mimic MS including but not limited to: neuromyelitis optica spectrum disease, Lyme disease, untreated Vitamin B12 deficiency, neurosarcoidosis, cerebrovascular disorders, and untreated hypothyroidism
Known active or uncontrolled bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds, including participants exhibiting symptoms consistent with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 6 weeks prior to Day 1
Participants with a current diagnosis of epilepsy
Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, gastrointestinal or other major diseases
History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening. Basal or squamous cell carcinoma of the skin that has been excised and is considered cured and in situ carcinoma of the cervix treated with apparent success by curative therapy \>1 year prior to screening is not exclusionary
History of inflammatory bowel disease or other clinically significant gastrointestinal disorders
Any concomitant disease that may require treatment with systemic corticosteroids or immunosuppressants during course of the study
History of currently active primary or secondary (non-drug-related) immunodeficiency
History of hypersensitivity to biologic agents or any of the excipients in the formulation
Only for cohorts where CSF samples are planned to be collected: Participants with a history of spinal cord compression, raised intra-cerebral pressure, clinically significant vertebral joint pathology or any other current abnormalities in the lumbar region which could prevent the lumbar puncture procedure.
Treatment with any approved MS treatment at Screening. Participants may become eligible after completion of a washout period prior to acquiring any screening laboratory tests but should not be withdrawn from therapies for the sole purpose of meeting eligibility for the trial
Previous treatment with RO7121932, alemtuzumab, cladribine, mitoxantrone, cyclophosphamide, total body irradiation, bone marrow transplantation, and hematopoietic stem cell transplantation. For the USA only, previous treatment with daclizumab
Previous treatment with anti-CD20 B-cell-depleting therapies (e.g., rituximab, ocrelizumab, or ofatumumab)
\<12 months prior to acquiring any screening laboratory tests,
≥12 months prior to acquiring any screening laboratory tests, if B-cells are outside the normal range, or not back to individual baseline ± 20% (if data are available),
If discontinuation of a prior B-cell depletion therapy was motivated by safety reasons
Current or prior treatment with natalizumab (if \<24 months prior to acquiring any screening laboratory tests)
Positive result on human immunodeficiency virus (HIV1) and HIV2, hepatitis C, or hepatitis B
Participants with SI or behavior within 6 months prior to Screening or participants who, in the Investigator's judgment, pose a suicidal or homicidal risk
Vaccination with a live or live-attenuated vaccine within 6 weeks prior to Day 1

What this trial measures

  • 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 ReactionsDay 1 to Day 253