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Tests treatment safety and results for Multiple Sclerosis
Official title A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis
ClinicalTrials.gov ID: NCT05704361
What this study is testing
What is RO7121932 IV?
RO7121932 IV is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for multiple sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary purpose of the study is to evaluate the safety and tolerability of a single-ascending intravenous (IV) dose (Part 1), a single-ascending subcutaneous (SC) dose (Part 2), and multiple ascending SC doses (Part 3) of RO7121932 in participants with multiple sclerosis (MS).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Participants not treated with any approved MS treatment at Screening and not planning to start on any MS therapy during the study (including...
- Female participants must practice abstinence or otherwise use contraception
You likely can't join if
- Evidence of clinical disease activity as defined by any clinical relapse within 3 months prior to screening, or by \>1 clinical relapse within 12...
- Evidence of magnetic resonance imaging (MRI) activity as defined by the presence of ≥ 1 Gadolinium (Gd)-enhancing T1 lesion in the screening MRI 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...
- Known active or uncontrolled bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds, including...
- Participants with a current diagnosis of epilepsy
See the full eligibility 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
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Previous treatment with RO7121932, alemtuzumab, cladribine, mitoxantrone, cyclophosphamide, total body irradiation, bone marrow transplantation, and hematopoietic stem cell transplantation. For the USA only, previous...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- New Haven, Connecticut, United States
- Tampa, Florida, United States
- Worcester, Massachusetts, United States
- Cincinnati, Ohio, United States
- Brussels, Belgium
- Ghent, Belgium
- Montreal, Quebec, Canada
- Dresden, Germany
- Göttingen, Germany
- München, Germany
- Münster, Germany
- Tübingen, Germany
- Ulm, Germany
- Jerusalem, Israel
- Tel Aviv, Israel
- Milan, Lombardy, Italy
- Chisinau, Moldova
- Gda?sk, Poland
- Grudzi?dz, Poland
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; New Haven, Connecticut, United States; Tampa, Florida, United States; Worcester, Massachusetts, United States; Cincinnati, Ohio, United States; Brussels, Belgium and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.