A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis (NCT07667322)
A Phase 1b Multicenter, Non-randomized, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Single Ascending Doses of a New Subcutaneous Formulation of Ocrelizumab in Patients With Multiple Sclerosis
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Profound Research, LLC — Carlsbad, California
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- Profound Research, LLC — Carlsbad, California
- Neurology Associates, PA — Maitland, Florida
- University of South Florida — Tampa, Florida
- Shepherd Center Inc. — Atlanta, Georgia
- John Hopkins University School of Medicine — Baltimore, Maryland
- Hope Neurology — Knoxville, Tennessee
- Instituto de Neurologia de Curitiba — Curitiba, Paraná
- Centro de Pesquisas Clinicas — São Paulo, São Paulo
- Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C. — Guadalajara, Jalisco
- Inovacion y Desarrollo en ciencias de la salud — Mexico City, Mexico CITY (federal District)
- Nottingham University Hospitals NHS Trust — Nottingham,
- Morriston Hospital — Swansea,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Multiple Sclerosis
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- MSCopilot Users' Feedback in Real Life - Outcomes Regarding Integration in Patients' pathWay and Users' ExpeRience — New Orleans, Louisiana
- A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis — Phoenix, Arizona
- A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS) — Carlsbad, California
- The Synergistic Effects of AIH and FES in Persons With MS — Chicago, Illinois
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Explore by condition: All Multiple Sclerosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.