ClinicaliQ Trial Snapshot
- A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis — Recruiting • Phase I • Neurology • NCT07667322.
- Being tested: Safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of a new subcutaneous formulation of ocrelizumab (an anti-CD20 monoclonal antibody) in multiple sclerosis patients, with dose-escalation and dose-continuation phases to establish optimal dosing.
- Patient eligibility overview: The trial includes participants with multiple sclerosis across varying disease types; specific inclusion/exclusion criteria determine suitability (detailed in full protocol), with participants progressing through escalating doses under close monitoring.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The main purpose of this study is to evaluate the safety and tolerability of the ocrelizumab subcutaneous (SC) test formulation in participants with multiple sclerosis (MS). The study consists of two treatment phases: a dose-escalation and dose-continuation phase. Participants will receive single ascending doses of ocrelizumab SC during an initial dose-escalation phase, with the option to continue treatment with the selected dose of ocrelizumab SC in the dose-continuation phase.
Eligibility Snapshot
- : * Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018) * Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.