What is RO7121932 studying for multiple sclerosis?

RO7121932 is being studied to evaluate its safety, tolerability, and how the body processes it in adults with multiple sclerosis. The research aims to understand these effects to inform future treatments. Hoffmann-La Roche is leading this study to assess different doses given by intravenous and subcutaneous routes.

Who may be eligible for this multiple sclerosis clinical trial?

Adults aged 18 to 65 years with relapsing or progressive multiple sclerosis who are not currently on MS treatment may be eligible. Participants should not have recent MS relapses or active infections and must be able to use contraception if female. Please review eligibility criteria for more details.

Is there any cost to participate in this multiple sclerosis clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation needs.

Actively Recruiting

Phase 1

Age: 18Years - 65Years

All Genders

ID05704361

Study of RO7121932 Given by Intravenous and Subcutaneous Routes to Assess Safety and Tolerability in Adults With Multiple Sclerosis

Led by Hoffmann-La Roche · Updated on 2026-05-27

129

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and tolerability of RO7121932 given by intravenous IV and subcutaneous SC routes in adults with multiple sclerosis MS. This Phase 1 study tests different single ascending doses and multiple ascending doses to understand how the body processes the drug and its effects on participants with relapsing or progressive MS who are not currently on approved MS treatments. Participants will receive RO7121932 either as a single IV dose starting at 7 mg and increasing up to 2000 mg, a single SC dose starting at 70 mg escalating to 200 mg, or multiple weekly SC doses ranging from 70 mg to 700 mg over 22 days. Dose adjustments may occur based on emerging safety and tolerability data. The study includes three parts Part 1 with single ascending IV doses, Part 2 with single ascending SC doses, and Part 3 with multiple ascending SC doses. During the study, participants will be monitored closely for adverse events and changes in suicide risk over several months. Assessments include injection site reactions, blood and cerebrospinal fluid sampling to measure drug concentration and immune cell changes, and antibody development against RO7121932. The study tracks pharmacokinetics and pharmacodynamics over up to 197 days depending on the treatment part, with safety and immune effects as key outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Expanded Disability Status Scale (EDSS) score 64 7.0 at Screening
Diagnosis of relapsing or progressive multiple sclerosis based on McDonald 2017 criteria
Not currently treated with any approved MS therapy and not planning to start MS treatment during the study
Female participants must use contraception or practice abstinence

You will not qualify if you...

Clinical relapse within 3 months prior to screening or more than 1 relapse within 12 months
MRI showing 65 1 Gadolinium-enhancing T1 lesion or 64 new/enlarging T2 lesions compared to reference
Active or history of progressive multifocal leukoencephalopathy (PML)
Other neurological disorders that mimic MS
Active or uncontrolled infections, including recent COVID-19 symptoms
Current diagnosis of epilepsy
Major systemic diseases including cardiac, metabolic, hepatic, psychiatric, and others
History of cancer within 10 years except certain cured skin or cervical cancers
Use of systemic corticosteroids or immunosuppressants during the study
History of active primary or secondary immunodeficiency
Hypersensitivity to biologic agents or formulation excipients
For lumbar puncture cohorts, conditions preventing safe cerebrospinal fluid collection
Prior treatment with specific MS therapies within defined washout periods
Participation in other investigational studies within 30 days or longer depending on drug half-life
Positive HIV, hepatitis B or C tests
Suicidal or homicidal risk within 6 months or judged unsafe by investigator
Recent vaccination with live or live-attenuated vaccines within 6 weeks before Day 1

Research Team

Reference Study ID Number: BP42230 https://forpatients.roche.com/

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