A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis (NOVA-BEAM)

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Relapsing Multiple Sclerosis
• Intervention / Treatment: Drug: RO7845860

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
• Study Contact Backup: Name: Reference Study ID Number BP46580 https://forpatients.roche.com/ No attachments to email below.; Phone Number: 888-662-6728 (U.S. and Canada); Email: global-roche-genentech-trials@gene.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Single Ascending Dose Escalation; Participants will receive single dose of RO7845860.	Drug: RO7845860; Participants will receive RO7845860 as an subcutaneous (SC) injection per the schedule in the protocol.
Experimental: Part 2: Multiple Ascending Dose Escalation; Participants will receive multiple doses of RO7845860.	Drug: RO7845860; Participants will receive RO7845860 as an subcutaneous (SC) injection per the schedule in the protocol.
Experimental: Part 3: Dose Expansion; Participants will receive multiple doses of RO7845860.	Drug: RO7845860; Participants will receive RO7845860 as an subcutaneous (SC) injection per the schedule in the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Parts 1, 2 and 3: Prevalence and Incidence of Anti-drug Antibodies (ADAs) to RO7845860	From Baseline up to approximately Week 96

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

Helpful 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 record dates

Study Major Dates

• Study Start (Estimated): November 23, 2026
• Primary Completion (Estimated): February 28, 2031
• Study Completion (Estimated): February 28, 2031

Study Registration Dates

• First Submitted: August 3, 2026
• First Submitted That Met QC Criteria: August 3, 2026
• First Posted (Actual): August 6, 2026

Study Record Updates

• Last Update Posted (Actual): September 3, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BP46580; 2026-526353-34-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No