Recent Updates
Recently added Catalysts

RO7845860

Phase 1

Relapsing Multiple Sclerosis | Small molecule | Neurology |Roche Holding AG|Last Updated: Sep 3, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment85

FDA Designations

No designations recorded

Clinical trial landscape

RO7845860 · 1 trial · 1 indication

Phase 1 1
NCT07749157A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple SclerosisRelapsing Multiple Sclerosis
NOT YET_RECRUITING85 Analytics
PHASE1NOT YET_RECRUITING
A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis
NCT0774915785
Unlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Single Ascending Dose EscalationEXPERIMENTALParticipants will receive single dose of RO7845860.
Part 2: Multiple Ascending Dose EscalationEXPERIMENTALParticipants will receive multiple doses of RO7845860.
Part 3: Dose ExpansionEXPERIMENTALParticipants will receive multiple doses of RO7845860.

Interventions

NameTypeDescription
RO7845860DRUGParticipants will receive RO7845860 as an subcutaneous (SC) injection per the schedule in the protocol.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo

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 neuro...

Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWSep 3, 2026NCT07749157lastUpdatePostDate: changed
LOWSep 3, 2026NCT07749157lastUpdatePostDate: changed
LOWAug 6, 2026NCT07749157NEW_TRIAL: changed
LOWAug 6, 2026NCT07749157NEW_TRIAL: changed

Frequently asked questions about RO7845860

What is RO7845860 used for in relapsing multiple sclerosis?

RO7845860 is an investigational small molecule being developed for the treatment of relapsing multiple sclerosis. It is administered subcutaneously and is currently in Phase 1 clinical development. The drug is not yet approved and is being studied in a controlled clinical trial to evaluate its safety and effects in participants with this condition.

Who makes RO7845860?

RO7845860 is being developed by Roche Holding AG, a multinational healthcare company. Roche is conducting a Phase 1 clinical trial to investigate the drug's potential in treating relapsing multiple sclerosis. The company is responsible for the research, development, and potential future commercialization of this investigational therapy.

What phase is RO7845860 in?

RO7845860 is in Phase 1 clinical development. This early-stage trial is designed to assess the safety, tolerability, and pharmacokinetics of the drug in participants with relapsing multiple sclerosis. The study is not yet recruiting and is a controlled, non-randomized trial with an estimated enrollment of 85 participants.

What clinical trials is RO7845860 in?

RO7845860 is being studied in a single Phase 1 clinical trial with the identifier NCT07749157. The trial is titled 'A Study of Subcutaneously Administered RO7845860 in Participants With Relapsing Multiple Sclerosis' and is currently in the not-yet-recruiting stage. The study plans to enroll 85 participants aged 18 years and older.

How is RO7845860 administered?

RO7845860 is administered subcutaneously, meaning it is given as an injection under the skin. This route of administration is specified in the ongoing Phase 1 clinical trial for relapsing multiple sclerosis. The study is designed to evaluate the drug's safety and effects when delivered via this method.