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A clinical trial to look at the safety and effectiveness of a higher dose of ocrelizumab to treat patients with primary progressive multiple sclerosis.
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)
- Autoimmune Disorder
- Multiple Sclerosis (MS)
Please note that the recruitment status of the trial at your site may differ.
Trial Status:
Active, not recruiting
This trial runs in
Cities
- Aalborg
- Ankara
- Athina
- Aurora
- Barcelona
- Bern
- Besançon
- Birmingham
- Boston
- Braga
- Brest
- Budapest
- Buenos Aires
- Bydgoszcz
- Caen
- Cherkasy
- Ciudad de México
- Clearwater
- Clermont-Ferrand
- Cleveland
- Dallas
- Denver
- Distrito Federal
- Dnipro
- Dresden
- El Palmar
- Farmington
- Farmington Hills
- Franklin
- Gallarate
- Gdańsk
- Glostrup
- Goiás
- Great Neck
- Greifswald
- Guadalajara
- Győr
- Hannover
- highland-beach
- Irvine
- İstanbul
- Ivano-Frankivs'k
- İzmir
- Kaposvár
- Katowice
- Kayseri
- Kazan
- Kharkiv
- kirov-oblast
- Kistarcsa
- Knoxville
- kocaeli
- Kraków
- Krasnodar
- Krasnoyarsk
- Kyiv
- La Victoria
- Larissa
- Lazio
- Leipzig
- Lille
- Lima
- Lisboa
- Lisbon
- Lombardia
- Lombardy
- London
- Lublin
- Luts'k
- Lviv
- Lévis
- Madrid
- Majadahonda
- Memphis
- mersin
- Milwaukee
- Montréal
- Moscow Oblast
- Münster
- Nancy
- Napoli
- neptune-township
- New York
- Newcastle upon Tyne
- nicholasville
- Novosibirsk
- o_wi_cim
- Paraná
- Pavia
- Pelt
- Perm
- Phoenix
- Pleven
- Plewiska
- Plymouth
- Porto
- Porto Alegre
- Poznań
- Pozuelo de Alarcón
- Rio Grande do Sul
- Rosario
- Rybnik
- Rzeszów
- Saint Petersburg
- Samsun
- San Antonio
- San Luis Potosí
- Sankt-Peterburg
- Santa Catarina
- Sherman
- sivas
- Sofia
- St. Louis
- St. Petersburg
- Stanford
- Strasbourg
- Sumy
- Szczecin
- São Paulo
- Tampa
- Thessaloniki
- timonium
- Torino
- Tübingen
- Ulm
- ulyanovsk
- Vinnytsia
- Warszawa
- Wiesbaden
- windsor
- Worcester
- Yekaterinburg
- Zaporizhzhia
- Łódź
- Πειραιας
Trial Identifier:
NCT04548999 2020-000894-26 BN42083
Trial 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.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04548999,BN42083,2020-000894-26
Trial Identifier
All
Gender
≥18 Years & ≤ 55 Years
Age
No
Healthy Volunteers
How does the BN42083 clinical trial work?
This clinical trial is recruiting people who have a type of multiple sclerosis. In order to take part, patients must have been diagnosed with primary progressive multiple sclerosis.
The purpose of this clinical trial is to compare the effects, good or bad, of the currently approved dose of ocrelizumab with a higher dose of ocrelizumab in patients with primary progressive multiple sclerosis. If you take part in this clinical trial, you will receive either the approved dose or a higher dose of ocrelizumab.
How do I take part in this clinical trial?
To be able to take part in this clinical trial, you must have been diagnosed with primary progressive multiple sclerosis, and not have any other significant health conditions.
You cannot join the trial if you are pregnant or breastfeeding. If you have previously received certain treatments for your multiple sclerosis within a certain amount of time, you may not be able to take part.
If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can find the locations of the clinical sites where you can enrol in this clinical trial on this page.
You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.
Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.
While taking part in the clinical trial, women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons.
What treatment will I be given if I join this clinical trial?
The treatment in this clinical trial will start with an initial screening period of between 6–24 weeks, followed by Part 1 (see below). If Part 1 is successful, the study will continue with Part 2 (see below).
Part 1
Everyone who joins this clinical trial will be split into two groups and given either
- Group 1: A higher dose of ocrelizumab, given as an infusion into the vein, every 24 weeks for at least 5 doses for a minimum of 120 weeks. See section 4 for details of how long treatment and follow up will last.
- OR Group 2: The currently approved dose of ocrelizumab, given as an infusion into the vein, every 24 weeks for at least 5 doses for a minimum of 120 weeks. See section 4 for details of how long treatment and follow up will last.
Twice as many people will be assigned to Group 1, meaning that you will have a 2 in 3 chance of receiving the higher dose of ocrelizumab, and a 1 in 3 chance of being assigned to Group 2 and receiving the approved dose.
This part of the study is called ‘double-blind’, which means that both doctors and patients will not know which treatment a patient is being given.
If Part 1 shows that the higher dose of ocrelizumab is superior to the currently approved dose, you may be able to join the second part of the study (Part 2).
Part 2
- Everyone will receive a higher dose of ocrelizumab, given as an infusion into the vein, every 24 weeks for 4 doses over 96 weeks
This part of the study is called ‘open-label’, which means that both doctors and patients will know which treatment patients are being given.
How often will I be seen in follow-up appointments and for how long?
You will be given the clinical trial treatment ocrelizumab at either a higher dose or approved dose every 24 weeks for a minimum of 120 weeks. Treatment will continue until study data for Part 1 can be analysed, so the length of Part 1 will depend on when you enter the study. The estimated maximum length of Part 1 can exceed 4 years. If Part 1 finds that a higher dose of ocrelizumab is superior to the currently approved dose, you may be given the opportunity to join Part 2 of the study and receive a higher dose every 24 weeks for 96 weeks. You are free to stop this treatment at any time and this will not change your standard medical care.
Although treatment will only be given every 24 weeks, you will still have scheduled visits every 12 weeks during the trial, where doctors will perform tests and checks to see how you are responding to the treatment and any side effects that you may be having. You will continue to be seen regularly by the clinical trial doctor after your last treatment for at least 48 weeks, for safety reasons.
What happens if I am unable to take part in this clinical trial?
If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.
For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov
Trial-identifier: NCT04548999
Trial 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.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04548999,BN42083,2020-000894-26
Trial Identifier
Ocrelizumab, Ocrelizumab, Antihistamine, Methylprednisolone
Treatments
Multiple Sclerosis
Condition
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 Primary Progressive Multiple Sclerosis
Eligibility Criteria
All
Gender
≥18 Years & ≤ 55 Years
Age
No
Healthy Volunteers
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
- 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
- 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
- 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.
- Participants must be neurologically stable for at least 30 days prior to randomization and baseline.
- 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.
- 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.
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.
- 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 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
- 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. 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.
For the latest version of this information please go to www.forpatients.roche.com