Health TrialsbyHealthPanel

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

ConditionRelapsing 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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • RO7845860

    Drug

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

Treatment groups

85 Participants
are divided into 3 treatment groups
Group A: Part 1: Single Ascending Dose EscalationExperimental treatment 1 intervention
Group B: Part 2: Multiple Ascending Dose EscalationExperimental treatment 1 intervention
Group C: Part 3: Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From Baseline up to approximately Week 96
2

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

Secondary outcomes

1

Part 1, 2 and 3: Serum Concentration of RO7845860

Time frame
At prespecified timepoints from Baseline up to approximately Week 96
2

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
3

Part 1, 2 and 3: B-Cell Levels Over Time in Blood

Time frame
From Baseline up to approximately Week 96
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: