A Study of Subcutaneously Administered RO7845860 in Participants With
An Open-Label, Multicenter, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
What it found
No result yet.
What was tested
Treatment tested
- RO7845860
What it measured
Main measures
Part 1, 2 and 3: Incidence and Severity of Adverse Events (AEs)
From Baseline up to approximately Week 96
SafetyPart 1, 2 and 3: Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
From Baseline up to approximately Week 96
Other measures (6)
Part 1, 2 and 3: Serum Concentration of RO7845860
At prespecified timepoints from Baseline up to approximately Week 96
How the body handles the medicinePart 1, 2 and 3: Percentage of Participants Achieving B-Cell Levels Below the Lower Limit of Quantitation in Blood as per Employed High-Sensitive Flow Cytometry Assay
From Baseline up to approximately Week 96
Immune responsePart 1, 2 and 3: B-Cell Levels Over Time in Blood
From Baseline up to approximately Week 96
Immune responseParts 1, 2 and 3: Median Time to Repletion of B-Cells in Blood to the Lower Limit of Normal or to the Detection Limit of the B-cell Assays
From Baseline up to approximately Week 96
Immune responseParts 2 and 3: Change From Baseline in B-Cell Levels in Cerebrospinal Fluid (CSF)
From Baseline up to approximately Week 96
Blood or spinal fluid markersImmune responseParts 1, 2 and 3: Prevalence and Incidence of Anti-drug Antibodies (ADAs) to RO7845860
From Baseline up to approximately Week 96
Immune response
Who could take part
Relapsing and progressive · 18 to 60 · EDSS 0 to 6.5
Show the full criteria
Inclusion criteria
* Diagnosis of RMS (i.e., relapsing-remitting multiple sclerosis [RRMS] or a secondary progressive multiple sclerosis [SPMS] where patients still experience relapses) in accordance with the revised 2017 McDonald Criteria. * No relapse for 30 days prior to screening and neurologically stable with no relapse during screening. * Expanded Disability Status Scale (EDSS) score at screening (historical EDSS not older than 6 months may be used), from 0 to 6.5 inclusive. * From Part 2 onwards, 1. at least two documented clinical relapses within the last 2 years prior to screening, or 2. one documented clinical relapse in the year prior to screening or 3. one documented clinical relapse together with signs of Magnetic Resonance Imaging (MRI) activity (any T1 Gd+ and/or new or enlarging T2 lesion) between 12 and 24 months prior to screening. * Documented MRI of brain with abnormalities consistent with Multiple Sclerosis (MS) at screening.
Exclusion criteria
* History of primary progressive multiple sclerosis (PPMS) at screening. * Any of the following laboratory parameters: 1. CD4 levels below lower limit of normal (LLN) 2. Absolute neutrophil count (ANC) levels below LLN 3. Serum immunoglobulin G (IgG) levels below LLN 4. Absolute lymphocyte count \< 1000 cells per microliter (μL) 5. B-cell levels below LLN * Known presence of other neurologic disorders that may mimic MS, including but not limited to, neuromyelitis optica spectrum disease, myelin oligodendrocyte antibody associated disease, Lyme disease, untreated vitamin B-12 deficiency, cerebrovascular or spinal vascular disorders, and untreated hypothyroidism. * Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, dermatologic, psychiatric, allergic, renal or other major diseases that in the investigator's judgement, may affect interpretation of study results or participant safety. * Prior treatment with Chimeric antigen receptor (CAR) T-cell therapy, gene-therapy product, total body irradiation, bone marrow transplantation, allograft organ transplant, or hematopoietic stem cell transplant at any point. * Inability to complete an MRI scan (contraindications for MRI, including but not restricted to, pacemaker, cochlear implants, intracranial vascular clips, surgery within 6 weeks prior to screening coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc.) or contraindication to gadolinium administration.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and, pharmacodynamics (PD) of subcutaneously administered RO7845860 in participants with relapsing multiple sclerosis (RMS).
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History
- Completion date changed from 28 February 2031 to 28 December 2031
Started
Dec 2026
Main results due
Feb 2031
Finished
Dec 2031