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 Primary Progressive Multiple Sclerosis

STATUS

Recruiting
End date

Nov 14, 2028
participants needed

699
sponsor

Hoffmann-La Roche

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Updated on 27 October 2022

See if I qualify

MRI

methylprednisolone

brain mri

disease or disorder

oligoclonal bands

ocrelizumab

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 PPMS, in comparison to the approved 600 mg dose of ocrelizumab.

Description

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 lower limit 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.

Details

Condition	Multiple Sclerosis
Treatment	Methylprednisolone, Ocrelizumab, Antihistamine
Clinical Study Identifier	NCT04548999
Sponsor	Hoffmann-La Roche
Last Modified on	27 October 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Diagnosis of primary progressive multiple sclerosis (PPMS)
	Expanded disability status scale (EDSS) score at screening and baseline, from 3 to 6.5 inclusive
	Average T25FWT score over two trials at screening and over two trials at baseline respectively, up to 150 (inclusive) seconds
	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
	Average 9HPT score over four trials (two trials with each hand) at screening and over four trials (two trials with each hand) at baseline respectively, up to 250 (inclusive) seconds
	Participants must be neurologically stable for at least 30 days prior to randomization and baseline
	Score of >/= to 2.0 on the Functional Systems scale for the pyramidal system that was due to lower extremity findings at screening and baseline
	Documented MRI of brain with abnormalities consistent with MS
	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
	Disease duration from the onset of MS symptoms; if EDSS score at screening is less or equal to 5, disease duration must be less than 10 years; If EDSS score at screening is more than 5, disease duration must be less than 15 years
	Documented evidence of the presence of at least one cerebrospinal fluid-specific oligoclonal bands
Exclusion Criteria
	History of relapsing remitting or secondary 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
	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
	Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study
	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 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
	Any previous treatment with mitoxantrone, cladribine, atacicept, alemtuzumab, and daclizumab
	Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
	Any previous history of transplantation or anti-rejection therapy
	Previous treatment with fingolimod, siponimod, or ozanimod within 6 weeks of baseline
	Treatment with intravenous (IV) immunoglobulin (Ig) or plasmapheresis within 12 weeks prior to randomization
	Previous treatment with natalizumab within 4.5 months of baseline
	Systemic corticosteroid therapy within 4 weeks prior to screening
	Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2 weeks of baseline
	Positive screening tests for active, latent, or inadequately treated hepatitis B
	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 additional exclusionary criterion as per ocrelizumab local label, if more stringent than the above
	Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab

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Study Definition

Wikipedia

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 Primary Progressive Multiple Sclerosis