Not yet recruiting NCT07749157
A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RO7845860.
- Who it may be relevant to
- Registry conditions: Relapsing Multiple Sclerosis. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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).
Interventions
- Drug RO7845860
Participants will receive RO7845860 as an subcutaneous (SC) injection per the schedule in the protocol.
Primary outcome measures
- Part 1, 2 and 3: Incidence and Severity of Adverse Events (AEs) [Time frame: From Baseline up to approximately Week 96]
- Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) [Time frame: From Baseline up to approximately Week 96]
Secondary outcome measures (6)
- Part 1, 2 and 3: Serum Concentration of RO7845860 [Time frame: At prespecified timepoints from Baseline up to approximately Week 96]
- Part 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 [Time frame: From Baseline up to approximately Week 96]
- Part 1, 2 and 3: B-Cell Levels Over Time in Blood [Time frame: From Baseline up to approximately Week 96]
- Parts 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 [Time frame: From Baseline up to approximately Week 96]
- Parts 2 and 3: Change From Baseline in B-Cell Levels in Cerebrospinal Fluid (CSF) [Time frame: From Baseline up to approximately Week 96]
- Parts 1, 2 and 3: Prevalence and Incidence of Anti-drug Antibodies (ADAs) to RO7845860 [Time frame: From Baseline up to approximately Week 96]
Eligibility 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,
- at least two documented clinical relapses within the last 2 years prior to screening, or
- one documented clinical relapse in the year prior to screening or
- 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:
- CD4 levels below lower limit of normal (LLN)
- Absolute neutrophil count (ANC) levels below LLN
- Serum immunoglobulin G (IgG) levels below LLN
- Absolute lymphocyte count < 1000 cells per microliter (μL)
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07749157 · BP46580 · 2026-526353-34-00