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Investigating a new treatment for Multiple Sclerosis

A Multiple-center, Non-randomized, Open-label, Adaptive, Single-ascending Dose (Part 1 and Part 2) and Multiple-ascending Dose (Part 3) Parallel, Phase IB Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of RO7121932 Following Intravenous (Parts 1) and Subcutaneous Administration (Parts 2 and 3) in Participants With Multiple Sclerosis

PHASE1 · Hoffmann-La Roche · NCT05704361

This study is testing a new medication for Multiple Sclerosis to see how safe it is and how well the body handles it when given in different ways.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment129 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorHoffmann-La Roche (industry)
Drugs / interventionsalemtuzumab, daclizumab, rituximab, ocrelizumab, ofatumumab, natalizumab, cyclophosphamide
Locations32 sites (Stanford, California and 31 other locations)
Trial IDNCT05704361 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of a new medication, RO7121932, administered both intravenously and subcutaneously in participants with Multiple Sclerosis. It consists of three parts: the first part assesses single ascending doses via IV, the second part examines single ascending doses via SC, and the third part focuses on multiple ascending doses via SC. The goal is to determine how well the body processes this medication and its safety profile in patients with relapsing or progressive forms of the disease.

Who should consider this trial

Good fit: Ideal candidates are individuals with relapsing or progressive Multiple Sclerosis who have not been treated with any approved MS therapies recently.

Not a fit: Patients with recent clinical disease activity or those currently on MS treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with Multiple Sclerosis.

How similar studies have performed: Other studies have shown promise with similar approaches in treating Multiple Sclerosis, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)
* 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 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, 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
* 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-cluster of differentiation 20 (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

Where this trial is running

Stanford, California and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Multiple Sclerosis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.