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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04544436




Registration number
NCT04544436
Ethics application status
Date submitted
4/09/2020
Date registered
10/09/2020
Date last updated
7/05/2021

Titles & IDs
Public title
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)
Scientific 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
Secondary ID [1] 0 0
2020-000893-69
Secondary ID [2] 0 0
BN42082
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ocrelizumab
Treatment: Drugs - Ocrelizumab
Treatment: Drugs - Antihistamine
Treatment: Drugs - Methylprednisolone

Experimental: Ocrelizumab Higher Dose - Participants will be randomized to receive a minimum of 5 higher treatment doses (1200 mg or 1800 mg) of ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the double blind treatment (DBT) phase. During the optional open-label extension (OLE) phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.

Active Comparator: Ocrelizumab Approved Dose - Participants will be randomized to receive a minimum of 5 treatment doses of 600 mg ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the DBT phase. During the optional OLE phase, participants will be offered a higher dose of ocrelizumab (either 1200 or 1800 mg), based on their body weight at OLE baseline, for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.


Treatment: Drugs: Ocrelizumab
The actual higher dose of ocrelizumab will be assigned to participants based on their body weight at baseline: 1200 mg (participants's body weight <75 kg) or 1800 mg (participant's body weight >/=75 kg). The first dose of ocrelizumab will be administered as two 600 mg or 900 mg intravenous (IV) infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 1200 mg or 1800 mg IV infusion every 24 weeks.

Treatment: Drugs: Ocrelizumab
Ocrelizumab will be administered at a dose of 600 milligram (mg) every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg intravenous (IV) infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks.

Treatment: Drugs: Antihistamine
Premedication with oral or IV antihistaminic drug (i.e., diphenhydramine 50 mg or an equivalent dose of an alternative) will be administered prior to each ocrelizumab infusion.

Treatment: Drugs: Methylprednisolone
Premedication with 100 mg of methylprednisolone (or equivalent) will be administered by IV infusion prior to each ocrelizumab infusion.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction in cCDP sustained for at least 12 weeks, measured by time to onset of cCDP sustained for at least 12 weeks. - Time to onset of cCDP is defined as the first occurrence of a predefined confirmed progression event measured by EDSS, T25FWT or 9-HPT.
Timepoint [1] 0 0
Baseline up to approximately 4.3 years
Secondary outcome [1] 0 0
Time to Onset of 24-week cCDP (cCDP24) - Time to onset of cCDP is defined as the first occurrence of a predefined confirmed progression event measured by EDSS, T25FWT or 9-HPT.
Timepoint [1] 0 0
Up to Week 120
Secondary outcome [2] 0 0
Time to Onset of 12-week CDP (CDP12) - CDP, defined as a sustained increase from baseline in EDSS score of >/=1.0 point in participants with a baseline EDSS score of </=5.5 or a sustained increase of >/=0.5 points in participants with a baseline EDSS score of >5.5.
Timepoint [2] 0 0
Up to Week 120
Secondary outcome [3] 0 0
Time to Onset of 24-week CDP (CDP24) - CDP, defined as a sustained increase from baseline in EDSS score of >/=1.0 point in participants with a baseline EDSS score of </=5.5 or a sustained increase of >/=0.5 points in participants with a baseline EDSS score of >5.5.
Timepoint [3] 0 0
Up to Week 120
Secondary outcome [4] 0 0
Time to >/= 20% Increase in 12-week Confirmed by Timed 25-Foot Walk Test (T25FWT) - The T25FWT is a performance measure used to assess walking speed based on a timed 25-foot walk. The participant is directed to start at one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly and safely as possible.
Timepoint [4] 0 0
Up to Week 120
Secondary outcome [5] 0 0
Time to >/= 20% Increase in 24-week Confirmed T25FWT - The T25FWT is a performance measure used to assess walking speed based on a timed 25-foot walk. The participant is directed to start at one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly and safely as possible.
Timepoint [5] 0 0
Up to Week 120
Secondary outcome [6] 0 0
Annual rate of change from baseline in Multiple Sclerosis Impact Scale (MSIS-29) physical scale - The MSIS-29 is a 29-item participant-reported measure of the physical and psychological impacts of MS. Participants are asked to rate how much their functioning and well-being has been impacted over the past 14 days on a 4-point scale, from "Not at all" (1) to "Extremely" (4).
Timepoint [6] 0 0
Baseline to Week 120
Secondary outcome [7] 0 0
Annual rate of percent change from baseline in total brain volume
Timepoint [7] 0 0
Week 24 to Week 120
Secondary outcome [8] 0 0
Time to 12-week Confirmed 4-point Worsening in Symbol Digit Modality Test (SDMT) - The SDMT is a performance measure that has demonstrated sensitivity in detecting not only the presence of cognitive impairment but also changes in cognitive functioning over time and in response to treatment. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Responses will be collected orally. A four-point change from baseline is typically considered clinically meaningful.
Timepoint [8] 0 0
Baseline up to approximately 4.3 years
Secondary outcome [9] 0 0
Serum Concentration of Ocrelizumab at Specified Timepoints
Timepoint [9] 0 0
Week 0, 2, 12, 24, 36, 48, 60, 72, 84, 96, 120
Secondary outcome [10] 0 0
Change in B-cell Levels in Blood
Timepoint [10] 0 0
Baseline up to approximately 4.3 years
Secondary outcome [11] 0 0
Proportion of Participants Achieving 5 or Less B-cells per Microliter of Blood
Timepoint [11] 0 0
Baseline up to approximately 4.3 years
Secondary outcome [12] 0 0
Proportion of Participants Achieving 5 or Less B-cells per Microliter of Blood in Participants with the High versus Low Affinity Fcgamma Receptor 3A (FcgR3A) Genotype per Arm
Timepoint [12] 0 0
Week 0, 2, 12, 24, 36, 48, 60, 72, 84, 96, 120
Secondary outcome [13] 0 0
Change from Baseline in the Anti-Drug Antibody (ADA) Levels
Timepoint [13] 0 0
Week 0, 24, 48, 72, 96, 120
Secondary outcome [14] 0 0
Levels of Neurofilament Light Chain (NfL) in Blood
Timepoint [14] 0 0
Baseline up to approximately 4.3 years
Secondary outcome [15] 0 0
Levels of Interleukin-6 (IL-6) in Blood
Timepoint [15] 0 0
Baseline up to approximately 4.3 years
Secondary outcome [16] 0 0
Levels of Blood B-cells - Levels of blood B-cells is based on a highly sensitive assay that can accurately measure below 5 B-cells per microliter in blood
Timepoint [16] 0 0
Baseline up to approximately 4.3 years
Secondary outcome [17] 0 0
Levels of Lymphocytes in Blood
Timepoint [17] 0 0
Baseline up to approximately 4.3 years
Secondary outcome [18] 0 0
Proportion of Participants with Different DNA Genotypes
Timepoint [18] 0 0
Week 0, 2, 12, 24, 48, 72, 96, 120

Eligibility
Key inclusion criteria
- 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), 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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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) if in the last 2 years before
screening, or if B-cell count is not normal, or if treatment was stopped due to safety
reasons or lack of efficacy.

- Any previous treatment with mitoxantrone, cladribine, atacicept, alemtuzumab, and
daclizumab

- 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 use of mitoxantrone, cladribine, atacicept, and alemtuzumab.

- 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.

- 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 of ocrelizumab.

- Any additional exclusionary criterion as per ocrelizumab local label, if more
stringent than the above.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Specialists on College; Neurology - Kent Town
Recruitment hospital [3] 0 0
Austin Hospital; Department of Neurology - Heidelberg
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
5067 - Kent Town
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Arizona
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Indiana
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??a????a
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Istanbul
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Lzmir
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Trabzon
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Chernihiv Governorate
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Katerynoslav Governorate
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Kharkiv Governorate
Country [149] 0 0
Ukraine
State/province [149] 0 0
Kherson Governorate
Country [150] 0 0
Ukraine
State/province [150] 0 0
KIEV Governorate
Country [151] 0 0
Ukraine
State/province [151] 0 0
Tavria Okruha
Country [152] 0 0
Ukraine
State/province [152] 0 0
Cherkasy
Country [153] 0 0
Ukraine
State/province [153] 0 0
Chernihiv
Country [154] 0 0
Ukraine
State/province [154] 0 0
Chernivtsi
Country [155] 0 0
Ukraine
State/province [155] 0 0
Ivano-Frankivsk
Country [156] 0 0
Ukraine
State/province [156] 0 0
Kharkov
Country [157] 0 0
Ukraine
State/province [157] 0 0
Lutsk
Country [158] 0 0
United Kingdom
State/province [158] 0 0
Coventry
Country [159] 0 0
United Kingdom
State/province [159] 0 0
London
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Nottingham
Country [161] 0 0
United Kingdom
State/province [161] 0 0
Plymouth
Country [162] 0 0
United Kingdom
State/province [162] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT04544436
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BN42082 www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
Global-Roche-Genentech-Trials@gene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04544436