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

Recruiting

Trial ID: NCT05704361

Purpose

The primary purpose of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) doses of RO7121932 in participants with multiple sclerosis (MS)

Official Title

A Multiple-center, Non-randomized, Open-label, Adaptive, Single Ascending Dose, Phase I Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of RO7121932 Following Intravenous Administration in Patients With Multiple Sclerosis

Stanford Investigator(s)

Christopher Lock
Christopher Lock

Clinical Associate Professor, Neurology & Neurological Sciences

Eligibility


Inclusion Criteria:

   - Expanded Disability Status Scale (EDSS) score ≤7.0 at Screening

   - Participants with RMS or 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 recent clinical disease activity

   - Evidence of recent MRI activity

   - 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

   - Cohorts 5 and 6 and later cohorts, as appropriate: 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 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 PD or 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 suicidal ideation 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

Intervention(s):

drug: RO7121932

Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305