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

Part of paid clinical trials in Carlsbad, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT07074886
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ocrelizumab Test Formulation — DRUG
    Ocrelizumab test formulation will be administered as per the schedule specified in the respective arm.
  • Ocrelizumab Reference Formulation — DRUG
    Ocrelizumab reference formulation will be administered as per the schedule specified in the respective arm.

Study Details

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.

Key Dates

Start date
Nov 13, 2025
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Oct 30, 2030

Study Design

Enrollment
182 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ocrelizumab Test Formulation
    Participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the controlled phase and continuation phase.
  • Active Comparator: Ocrelizumab Reference Formulation
    Participants will receive ocrelizumab reference formulation, 920 mg, as SC injection, on Day 1 during the controlled phase. Thereafter, participants will receive ocrelizumab test formulation, as SC injection, as per a pre-defined dosing regimen during the continuation phase.

Primary Outcome Measure

Area Under the Serum Concentration-time Curve Over the First 12 Weeks Post-dose (AUC0-12W) of Ocrelizumab [ Time Frame: Up to 12 weeks ]

Central Contacts

  • Reference Study ID Number: CN45320 https://forpatients.roche.com/
    888-662-6728 (U.S.)
    [email protected]

Locations (9)

FacilityCityStateZIPSite coordinators
Profound Research, LLCCarlsbadCalifornia92011-
Advanced Neurology of Colorado, LLCFort CollinsColorado80528-
Neurology Associates PAMaitlandFlorida32751-
University of South FloridaTampaFlorida33612-
Johns Hopkins University School Of MedicineBaltimoreMaryland21287-
University of Massachusetts Medical SchoolWorcesterMassachusetts01605-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Hope NeurologyKnoxvilleTennessee37922-
Swedish Medical CenterSeattleWashington98104-

Find similar trials in Carlsbad, CA

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Multiple sclerosis
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By research site
Profound Research, LLC· Carlsbad, CAAdvanced Neurology of Colorado, LLC· Fort Collins, CONeurology Associates PA· Maitland, FLUniversity of South Florida· Tampa, FLJohns Hopkins University School Of Medicine· Baltimore, MDUniversity of Massachusetts Medical School· Worcester, MA

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