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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
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