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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHoffmann-La Roche

About this trial

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).

Eligibility criteria

Qualifiers

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,

Disqualifiers

History of primary progressive multiple sclerosis (PPMS) at screening.

CD4 levels below lower limit of normal (LLN)

Absolute neutrophil count (ANC) levels below LLN

Serum immunoglobulin G (IgG) levels below LLN

Trial design

Treatments tested in this trial

  • RO7845860

Treatment groups

85 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators