Relapsing Multiple SclerosisPhase 1NOVA-BEAMNCT07749157
A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
A Phase 1 study testing RO7845860 in people with Relapsing Multiple Sclerosis, run by Hoffmann-La Roche.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- RO7845860
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2026to 28 Dec 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number BP46580 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
About this study
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
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
- Being tested
- RO7845860
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7845860Drug
Participants will receive RO7845860 as an subcutaneous (SC) injection per the schedule in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single Ascending Dose Escalation | Experimental | Participants will receive single dose of RO7845860. Receives: Drug: RO7845860 |
| Part 2: Multiple Ascending Dose Escalation | Experimental | Participants will receive multiple doses of RO7845860. Receives: Drug: RO7845860 |
| Part 3: Dose Expansion | Experimental | Participants will receive multiple doses of RO7845860. Receives: Drug: RO7845860 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1, 2 and 3: Incidence and Severity of Adverse Events (AEs)
Measured: From Baseline up to approximately Week 96
Part 1, 2 and 3: Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: From Baseline up to approximately Week 96
Secondary outcomes (6)
Part 1, 2 and 3: Serum Concentration of RO7845860
Measured: 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
Measured: From Baseline up to approximately Week 96
Part 1, 2 and 3: B-Cell Levels Over Time in Blood
Measured: 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
Measured: From Baseline up to approximately Week 96
Parts 2 and 3: Change From Baseline in B-Cell Levels in Cerebrospinal Fluid (CSF)
Measured: From Baseline up to approximately Week 96
Parts 1, 2 and 3: Prevalence and Incidence of Anti-drug Antibodies (ADAs) to RO7845860
Measured: From Baseline up to approximately Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start14 Dec 2026 (estimated)
- Primary completion28 Feb 2031 (estimated)
- Study completion28 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749157
- Sponsor's protocol ID
- BP46580
- Other IDs
- 2026-526353-34-00
- Acronym
- NOVA-BEAM
- Status last verified
- Nov 2026
- First submitted
- 3 Aug 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07749157
- Acronym / sponsor ID
- NOVA-BEAM / BP46580
- Conditions
- Relapsing Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2026 (estimated)
- Primary completion
- 28 Feb 2031 (estimated)
- Study completion
- 28 Dec 2031 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single Ascending Dose Escalation | Experimental | Drug: RO7845860Participants will receive single dose of RO7845860. |
| Part 2: Multiple Ascending Dose Escalation | Experimental | Drug: RO7845860Participants will receive multiple doses of RO7845860. |
| Part 3: Dose Expansion | Experimental | Drug: RO7845860Participants will receive multiple doses of RO7845860. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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,
- Documented MRI of brain with abnormalities consistent with Multiple Sclerosis (MS) at screening.
Key exclusion criteria (11 listed)
- History of primary progressive multiple sclerosis (PPMS) at screening.
- Any of the following laboratory parameters:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7845860Participants will receive RO7845860 as an subcutaneous (SC) injection per the schedule in the protocol. | Drug | Part 1: Single Ascending Dose Escalation, Part 2: Multiple Ascending Dose Escalation, Part 3: Dose Expansion |
Primary outcome
Part 1, 2 and 3: Incidence and Severity of Adverse Events (AEs)
Time frame: From Baseline up to approximately Week 96
Part 1, 2 and 3: Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: From Baseline up to approximately Week 96
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number BP46580 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Hoffmann-La Roche
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7845860 in people with Relapsing Multiple Sclerosis, run by Hoffmann-La Roche.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number BP46580 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1, 2 and 3: Incidence and Severity of Adverse Events (AEs) (time frame: From Baseline up to approximately Week 96). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.