A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis

Part of paid clinical trials in Carlsbad, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT07667322
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Ocrelizumab Co-formulated With rHuPH20 — DRUG
    Participants will receive ocrelizumab co-formulated with rHuPH20, as a SC injection, per the schedule specified in the treatment arm.

Study Details

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.

Key Dates

Start date
Dec 17, 2024
Status verified
Jun 2026
Primary completion
Feb 15, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Ocrelizumab SC
    Participants will receive single ascending doses of ocrelizumab SC, co-formulated with recombinant human hyaluronidase (rHuPH20) on Day 1 of the 24 week dose-escalation phase. Participants who opt to continue treatment in the dose continuation phase will receive ocrelizumab SC at a dose determined in the dose escalation phase, every 24 weeks (Q24W) for 144 weeks.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 168 weeks ]

Central Contacts

  • Reference Study ID Number: WN45319 https://forpatients.roche.com/
    888-662-6728 (U.S. Only)
    [email protected]

Locations (6)

FacilityCityStateZIPSite coordinators
Profound Research, LLCCarlsbadCalifornia92011-
Neurology Associates, PAMaitlandFlorida32751-
University of South FloridaTampaFlorida33612-
Shepherd Center Inc.AtlantaGeorgia30309-
John Hopkins University School of MedicineBaltimoreMaryland21287-
Hope NeurologyKnoxvilleTennessee37922-

Find similar trials in Carlsbad, CA

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Profound Research, LLC· Carlsbad, CANeurology Associates, PA· Maitland, FLUniversity of South Florida· Tampa, FLShepherd Center Inc.· Atlanta, GAJohn Hopkins University School of Medicine· Baltimore, MDHope Neurology· Knoxville, TN

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