Phase 1 Multiple Sclerosis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have been diagnosed with relapsing multiple sclerosis (MS) or progressive MS, confirmed using internationally recognised diagnostic guidelines (McDonald 2017 criteria)
- People whose MS-related physical disability falls within a certain range, measured by a standard disability scale called the EDSS, with a score of 7.0 or below at the screening stage
- People who are not currently taking any approved MS medication at the time of screening, and who do not plan to start any MS medication during the study period, including the follow-up phase
- Female participants who either abstain from sexual activity or use contraception during the trial
Who may not be able to join:
- People who have had a clinical MS relapse within the 3 months before screening, or more than one relapse within the 12 months before screening
- People whose screening brain MRI scan shows signs of active disease, such as one or more enhancing lesions or four or more new or growing lesions compared to a previous scan
- People who have, or are suspected of having, a serious brain infection called progressive multifocal leukoencephalopathy (PML)
- People with other known neurological conditions that can look similar to MS, such as neuromyelitis optica, Lyme disease, untreated vitamin B12 deficiency, neurosarcoidosis, stroke-related disorders, or untreated thyroid conditions
- People with an active or poorly controlled infection of any kind — bacterial, viral, fungal, or other — including those who have had COVID-19 symptoms within 6 weeks before the study start date (Day 1)
- People who currently have a diagnosis of epilepsy
- People with serious ongoing conditions affecting the heart, metabolism, blood, liver, immune system, kidneys, lungs, mental health, skin, or other major organ systems
- People who have had a cancer diagnosis — including blood cancers or solid tumours — within the 10 years before screening (certain treated skin cancers and cervical conditions may not be disqualifying — confirm with trial site)
- People who have, or may develop, a condition during the study that would require treatment with steroids or immune-suppressing medications
- People with a current or past primary or secondary immune deficiency not related to medication use
- People with a known allergic reaction to biological medicines or to any ingredient in the study drug formulation
- For certain parts of the trial involving spinal fluid collection: people with a history of spinal cord compression, elevated pressure in the brain, significant spinal joint problems, or any other condition in the lower back area that could make a lumbar puncture (spinal tap) unsafe (confirm with trial site)
- People who are currently taking, or have recently taken, approved MS treatments — a washout period may apply in some cases, but people should not stop their current treatment solely to become eligible for this trial
- People who have previously been treated with certain specific MS or immune-suppressing medications, including alemtuzumab, cladribine, mitoxantrone, cyclophosphamide, bone marrow or stem cell transplantation, or the trial's investigational drug RO7121932 (and daclizumab for participants in the USA)
- People who have previously received B-cell depleting therapies (such as rituximab, ocrelizumab, or ofatumumab) within the past 12 months, or longer ago if certain blood cell levels have not returned to normal, or if those therapies were stopped due to safety concerns
- People who have taken natalizumab within the 24 months before the screening blood tests
- People who have participated in another clinical drug or medical device trial within 30 days before screening, or within a longer period depending on how long the previous study drug stays active in the body, whichever is longer
- People who test positive for HIV, hepatitis B, or hepatitis C
- People who have had thoughts of suicide or self-harm within the 6 months before screening, or who the trial investigator believes may pose a risk of suicide or harm to others
- People who have received a live or live-attenuated vaccine within 6 weeks before the study start date (Day 1)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Clinical Trials, Hoffmann-La Roche
Phone: 888-662-6728 (U.S. Only)
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Parts 1, 2, and 3: 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); Parts 1, 2, and 3: Change From Baseline in Suicide Risk as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS); Parts 2 and 3: Percentage of Participants With Local Pain at the Site of Injection Assessed Using the Visual Analog Scale (VAS); Parts 2 and 3: Percentage of Participants With Local Injection-site Reaction Using Local Injecti...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.