A Multiple-center, Non-randomized, Open-label, Adaptive, Single-ascending Dose (Part 1 and Part 2) and Multiple-ascending Dose (Part 3) Parallel, Phase IB Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of RO7121932 Following Intravenous (Parts 1) and Subcutaneous Administration (Parts 2 and 3) in Participants With Multiple Sclerosis

Hoffmann-La Roche

Summary

The primary purpose of the study is to evaluate the safety and tolerability of a single-ascending intravenous (IV) dose (Part 1), a single-ascending subcutaneous (SC) dose (Part 2), and multiple ascending SC doses (Part 3) of RO7121932 in participants with multiple sclerosis (MS).

Eligibility

Age range: 18–65 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Expanded Disability Status Scale (EDSS) score ≤7.0 at Screening * Participants with relapsing multiple sclerosis (RMS) or progressive multiple sclerosis (PMS) who fulfil international panel criteria for diagnosis (McDonald 2017 criteria) * Participants not treated with any approved MS treatment at Screening and not planning to start on any MS therapy during the study (including follow-up) * Female participants must practice abstinence or otherwise use contraception Exclusion Criteria: * Evidence of clinical disease activity as defined by any clinical relapse within 3 m…

Interventions

Drug
RO7121932 IV
Participants will receive RO7121932, as an IV infusion, per the schedule specified in the treatment arms.
Drug
RO7121932 SC
Participants will receive RO7121932, as SC injection, per the schedule specified in the treatment arms.

Locations (32)

Stanford University Medical Center
Stanford, California
Yale University Multiple Sclerosis Center
New Haven, Connecticut
University of South Florida
Tampa, Florida
University of Massachusetts Medical School
Worcester, Massachusetts
UC Health, LLC.
Cincinnati, Ohio
Cliniques Universitaires St-Luc
Brussels