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
- Conditions
- MSMultiple Sclerosis10012303
- Registration Number
- NL-OMON55134
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
• Ages 18-55 years at time of screening
• Ability to comply with the study protocol
• Diagnosis of RMS (i.e., RRMS or aSPMS where patients 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 (with no
relapse 30 days prior to screening and at baseline)
• Patients must be neurologically stable for at least 30 days prior to
randomization and baseline assessments
• 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 method.
• For female patients without reproductive potential: Females may be enrolled
if post menopausal unless the patient is receiving a hormonal therapy for her
menopause or if surgically sterile.
• History of primary progressive MS at screening
• Any known or suspected active infection at screening or baseline, or any
major episode of infection requiring hospitalization or treatment with IV anti
microbials within 8 weeks prior to and during screening or treatment with oral
anti microbials within 2 weeks prior to and during screening
• 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
• 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, including
uncontrolled psychosis for corticosteroids or closed angle glaucoma for
antihistamines
• Known presence of other neurologic disorders that could interfere withthe
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 patient 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 during the study
• 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), if in the last 2 years
before screening, or if B-cell count is not normal, or if the stop of the
treatment was motivated by safety reasons or lack of efficacy
• Any previous treatment with mitoxantrone, cladribine, atacicept, and
alemtuzumab
• 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
• Previous treatment with any other immunomodulatory or immunosuppressive
medication not already listed above without appropriate washout as described in
the applicable local label (washout to be completed prior to baseline). 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. The PD
effects of the previous medication must also be considered when determining the
required time for washout.
• Any previous treatment with bone marrow transplantation and hematopoietic
stem cell transplantation
• Any of previous history transplantation or anti-rejection therapy
• Treatment with IV 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 (Ocrevus) local
label, if more
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy objective is to demonstrate the superiority of a higher<br /><br>dose of ocrelizumab over the approved dose of ocrelizumab as assessed by risk<br /><br>reduction in cCDP sustained for at least 12 weeks.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary efficacy objective is to demonstrate superiority of a higher dose<br /><br>of ocrelizumab over the approved dose of ocrelizumab on the basis of the<br /><br>endpoints stated in protocol section 2.1.2<br /><br><br /><br>The exploratory efficacy objective for this study is to evaluate the efficacy<br /><br>of a higher dose of ocrelizumab compared with the approved dose of ocrelizumab<br /><br>on the basis of, but not limited to, the endpoints described in protocol<br /><br>section 2.1.3</p><br>