Summary

Eligibility
for people ages 18-55 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with RMS, in comparison to the approved 600 mg dose of ocrelizumab.

Official Title

A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis

Details

Participants will be treated for a minimum of 120 weeks in the double-blind phase. Upon positive primary results after the double-blind phase, an optional higher dose extension treatment (OLE phase) is planned for eligible participants. The OLE will be carried out for approximately 96 weeks. Participants will be followed for safety for 48 weeks thereafter. Participants whose B-cell levels still did not replete to their baseline level or the low level of normal (LLN), whichever is lower, will move into the B-cell monitoring (BCM) phase following the safety follow-up phase. The study will end when all participants who were not treated with an alternative B-cell depleting therapy have repleted their B-cells to the baseline value or the lower limit of normal.

Keywords

Multiple Sclerosis Sclerosis Methylprednisolone Ocrelizumab Histamine Antagonists Histamine H1 Antagonists Antihistamine Ocrelizumab Higher Dose Ocrelizumab Approved Dose

Eligibility

You can join if…

Open to people ages 18-55

  • Diagnosis of relapsing multiple sclerosis (RMS) (i.e., RRMS or aSPMS where participants still experience relapses) in accordance with the revised McDonald Criteria 2017
  • At least two documented clinical relapses within the last 2 years prior to screening, or one clinical relapse in the year prior to screening. No relapse 30 days prior to screening and at baseline.
  • Participants must be neurologically stable for at least 30 days prior to randomization and baseline.
  • Expanded disability status scale (EDSS) score, at screening and baseline, from 0 to 5.5 inclusive.
  • Average T25FWT score over two trials at screening and over two trials at baseline respectively, up to 150 (inclusive) seconds
  • Average 9HPT score over four trials at screening and over four trials at baseline respectively, up to 250 (inclusive) seconds
  • Documented MRI of brain with abnormalities consistent with MS at screening.
  • Participants requiring symptomatic treatment for MS and/or physiotherapy must be treated at a stable dose. No initiation of symptomatic treatment for MS or physiotherapy within 4 weeks of randomization.
  • For females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods.
  • For female participants, without reproductive potential may be enrolled if post-menopausal, unless receiving a hormonal therapy for her menopause or if surgically sterile

You CAN'T join if...

  • History of primary progressive MS at screening.
  • Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks or treatment with oral antimicrobials within 2 weeks, prior to and during screening.
  • History of confirmed or suspected progressive multifocal leukoencephalopathy.
  • History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening.
  • Immunocompromised state.
  • Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization.
  • Inability to complete an MRI or contraindication to gadolinium administration.
  • Contraindications to mandatory pre-medications for IRRs.
  • Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
  • Significant, uncontrolled disease that may preclude participant from participating in the study.
  • History of or currently active primary or secondary, non-drug-related, immunodeficiency.
  • Pregnant or breastfeeding or intending to become pregnant
  • Lack of peripheral venous access.
  • History of alcohol or other drug abuse within 12 months prior to screening.
  • Treatment with any investigational agent within 24 weeks prior to screening or treatment with any experimental procedure for MS.
  • Previous use of anti-CD20s (including ocrelizumab), unless the last infusion was more than 2 years before screening, B-cell count is normal, and the stop of the treatment was not motivated by safety reasons or lack of efficacy.
  • Previous treatment with fingolimod, siponimod, or ozanimod within 6 weeks of baseline
  • Previous treatment with natalizumab within 4.5 months of baseline
  • Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2 weeks of baseline
  • Any previous treatment with mitoxantrone, cladribine, atacicept, alemtuzumab, and daclizumab
  • Previous treatment with any other immunomodulatory or immunosuppressive medication not already listed above without appropriate washout as described in the applicable local label. If the washout requirements are not described in the applicable local label, then the wash out period must be five times the half-life of the medication.
  • Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation.
  • Any previous history of transplantation or anti-rejection therapy.
  • Treatment with intravenous (IV) immunoglobulin (Ig) or plasmapheresis within 12 weeks prior to randomization.
  • Systemic corticosteroid therapy within 4 weeks prior to screening.
  • Positive screening tests for active, latent, or inadequately treated hepatitis B.
  • Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab.
  • Any additional exclusionary criterion as per ocrelizumab local label, if more stringent than the above.

Locations

  • University of California Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Stanford University Medical Center; Stanford Neuroscience Health Center accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
Links
Sign up for this study
ID
NCT04544436
Phase
Phase 3
Study Type
Interventional
Last Updated