Relapsing Multiple Sclerosis
Conditions
Brief summary
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
DRUGRO7845860
Participants will receive RO7845860 as an subcutaneous (SC) injection per the schedule in the protocol.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) | From Baseline up to approximately Week 96 |
| Part 1, 2 and 3: Incidence and Severity of Adverse Events (AEs) | From Baseline up to approximately Week 96 |
Secondary
| Measure | Time frame |
|---|---|
| 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 | From Baseline up to approximately Week 96 |
| Parts 2 and 3: Change From Baseline in B-Cell Levels in Cerebrospinal Fluid (CSF) | From Baseline up to approximately Week 96 |
| Parts 1, 2 and 3: Prevalence and Incidence of Anti-drug Antibodies (ADAs) to RO7845860 | 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 | From Baseline up to approximately Week 96 |
| Part 1, 2 and 3: Serum Concentration of RO7845860 | At prespecified timepoints from Baseline up to approximately Week 96 |
| Part 1, 2 and 3: B-Cell Levels Over Time in Blood | From Baseline up to approximately Week 96 |
Contacts
CONTACTReference Study ID Number BP46580 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed