A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis

NCT07749157 | Not Yet Recruiting Phase 1

• 2 other identifiers: BP465802026-526353-34-00
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Part 1, 2 and 3: Incidence and Severity of Adverse Events (AEs)

  From Baseline up to approximately Week 96

• Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)

  From Baseline up to approximately Week 96

Secondary Outcomes (6)

• Part 1, 2 and 3: Serum Concentration of RO7845860

  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

  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

• 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

Study Arms (3)

Part 1: Single Ascending Dose Escalation

EXPERIMENTAL

Participants will receive single dose of RO7845860.

Drug: RO7845860

Part 2: Multiple Ascending Dose Escalation

EXPERIMENTAL

Participants will receive multiple doses of RO7845860.

Drug: RO7845860

Part 3: Dose Expansion

EXPERIMENTAL

Participants will receive multiple doses of RO7845860.

Drug: RO7845860

Interventions

RO7845860 DRUG

Participants will receive RO7845860 as an subcutaneous (SC) injection per the schedule in the protocol.

Part 1: Single Ascending Dose Escalation; Part 2: Multiple Ascending Dose Escalation; Part 3: Dose Expansion

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Related Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number BP46580 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): November 23, 2026
• Primary Completion (Estimated): February 28, 2031
• Study Completion (Estimated): February 28, 2031
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share