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New MS drug candidate enters early safety testing

NCT ID NCT05704361

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 6 times

Summary

This early-stage study is testing a new drug called RO7121932 in 129 people with multiple sclerosis (MS). The goal is to check if the drug is safe and how the body handles it when given as a single or multiple doses, either through a vein or under the skin. Participants are not on other MS treatments during the study. The results will help decide if further testing is warranted.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 119 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 Criteria: * 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. Prior/Concomitant Therapy: * 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) Prior/Concurrent Clinical Study Experience: \- Participation in an investigational drug medicinal product or medical device study within 30 days before Screening or within five times the pharmacodynamic (PD) or pharmacokinetic (PK) half-life (if known), whichever is longer Diagnostic Assessments: * 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

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Conditions

The condition(s) this trial relates to.

multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • ARENSIA Exploratory Medicine Phase I, PMSI Republican Clinical Hospital

    Chisinau, MD-2025, Moldova

  • ARENSIA Exploratory Medicine SRL - Bucharest (Monza Medical Center)

    Bucharest, 011658, Romania

  • ARENSIA Exploratory Medicine, County Emergency Hospital

    Cluj-Napoca, 40006, Romania

  • Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião

    Santa Maria da Feira, 4520-211, Portugal

  • Cliniques Universitaires St-Luc

    Brussels, 1200, Belgium

  • Fond. Istituto Neurologico C.Besta

    Milan, Lombardy, 20133, Italy

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001, Israel

  • Hospital Santo Antonio dos Capuchos

    Lisbon, 1169-050, Portugal

  • Hospital Universitari Vall dHebron (CEMCAT)

    Barcelona, 08035, Spain

  • Hospital de Braga

    Braga, 4710-243, Portugal

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Klinikum rechts der Isar der TU Muenchen

    München, 81675, Germany

  • MedPolonia

    Poznan, 60-693, Poland

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec, H3A 2B4, Canada

  • Osrodek Badan Klinicznych Euromedis

    Szczecin, 70-111, Poland

  • Regionalny Szpital Specjalistyczny im. W. Bieganskiego

    Grudzi?dz, 86-300, Poland

  • SPSK nr 1

    Zabrze, 41-800, Poland

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • UZ Gent

    Ghent, 9000, Belgium

  • University Clinical Center of Serbia

    Belgrade, 11000, Serbia

  • Universitätsklinikum "Carl Gustav Carus"

    Dresden, 01307, Germany

  • Universitätsklinikum Münster Klinik u. Poliklinik f. Neurologie

    Münster, 48149, Germany

  • Universitätsklinikum Tübingen, Zentrum für Neurologie

    Tübingen, 72076, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Universitätsmedizin Göttingen Georg-August-Universität

    Göttingen, 37075, Germany

  • Yale University Multiple Sclerosis Center

    New Haven, Connecticut, 06473, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.