🏛️ Verified NIH Record • Updated 2026-08-05

A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS) (NCT07074886)

A Phase II, Randomized, Open-label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients With Multiple Sclerosis

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

🩺 Plain-English Summary (8th-Grade Level)

The main purpose of this study is to assess the bioequivalence of ocrelizumab SC test formulation to the marketed ocrelizumab SC reference formulation in participants with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The study consists of 2 phases: a controlled phase, where participants in each group will receive one dose of test or reference formulation and a continuation phase, where all participants in both groups will receive ocrelizumab SC test formulation.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (15 items).

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 Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Participants who have previously received anti-cluster of differentiation (CD) 20s (including ocrelizumab) less than 2 years before screening
  • Participants who have previously received anti-CD20s (including ocrelizumab) more than 2 years before screening if one of the following conditions is met: B-cell count is below lower limit of normal (LLN), or the discontinuation of the treatment was due to safety reasons
  • History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
  • History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
  • Immunocompromised state
  • Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participation in the study
  • Lack of peripheral venous access
  • Previous treatment with cladribine, atacicept, and alemtuzumab

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (50 Sites)

Showing the first 25 of 50 sites.

  • Profound Research, LLC — Carlsbad, California
  • Advanced Neurology of Colorado, LLC — Fort Collins, Colorado
  • Neurology Associates PA — Maitland, Florida
  • University of South Florida — Tampa, Florida
  • Johns Hopkins University School Of Medicine — Baltimore, Maryland
  • University of Massachusetts Medical School — Worcester, Massachusetts
  • SUNY Upstate Medical University — Syracuse, New York
  • Hope Neurology — Knoxville, Tennessee
  • Swedish Medical Center — Seattle, Washington
  • Centro de Especialidades Neurológicas y Rehabilitación - CENyR — CABA, Buenos Aires
  • Focus CECIC — CABA, CABA / Buenos Aires
  • INECO Neurociencias Orono — Rosario, Santa Fe Province
  • IME - Instituto Médico Especializado — Buenos Aires,
  • Centro de Investigacion en Enfermedades Reumaticas CIER — Ciudad Autonoma Buenos Aires,
  • Sanatorio del Sur S.A. — San Miguel de Tucumán,
  • Santa Casa de Misericordia de Salvador — Salvador, Estado de Bahia
  • Instituto de Neurologia de Curitiba — Curitiba, Paraná
  • Cpn - Centro de Pesquisa Neurologica Porto Alegre Ltda — Porto Alegre, Rio Grande do Sul
  • Instituto do Cerebro do Rio Grande do Sul — Porto Alegre, Rio Grande do Sul
  • Clinica Neurológica e Neurocirúrgica de Joinville — Joinville, Santa Catarina
  • Centro de Pesquisas Clinicas - CPCLIN — São Paulo, São Paulo
  • Hôpital Guillaume et René Laënnec — Nantes,
  • CHU de Nimes - Hopital Universitaire Caremeau — Nîmes,
  • Charite - Universitätsmedizin Berlin — Berlin,
  • St. Josef-Hospital, Klinik für Neurologie — Bochum,

💰 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.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗