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A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis

Study Purpose

This study will evaluate the pharmacokinetics, pharmacodynamics, safety, immunogenicity, and radiological and clinical effects of subcutaneous (SC) administration of ocrelizumab compared with the intravenous (IV) infusion of ocrelizumab in patients with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosis of PPMS or RMS according to the revised McDonald 2017 criteria (Thompson et al.

2018)

- EDSS score, 0-6.5, inclusive, at screening.

- Neurological stability for ≥30 days prior to both screening and baseline.

- Disease duration from onset of MS symptoms of less than 15 years for patients with EDSS score <2.0 at screening.

- For females participants, without reproductive potential may be enrolled if post-menopausal, unless receiving a hormonal therapy for menopause or if surgically sterile.

- For females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods.

Exclusion Criteria:

- 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 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-attenuated vaccine within 6 weeks prior to randomization Influenza vaccination is permitted if the inactivated vaccine formulation is administered.

- Inability to complete an MRI or contraindication to gadolinium administration.

- Contraindications to mandatory premedications for IRRs, including closed-angle glaucoma for antihistamines.

- Known presence of other neurologic disorders.

- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.

- Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant 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 and 6 or 12 months.

- 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 5 half-lives of the investigational drug (whichever is longer), or treatment with any experimental procedure for MS (e.g., treatment for chronic cerebrospinal venous insufficiency) - Participants who have previously received anti-CD20s if the last treatment was less than 2 years before screening, and/or if B-cell count is below lower limit of normal, and/or the discontinuation of the treatment was due to safety reasons or lack of efficacy.

- Previous treatment with cladribine, atacicept, and alemtuzumab.

- Previous treatment with fingolimod, siponimod, ponesimod, or ozanimod within 6 weeks of baseline.

- Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2 weeks of baseline.

- Previous treatment with natalizumab within 4.5 months of baseline.

- Treatment with mitoxantrone within 2 years prior to baseline visit or evidence of cardiotoxicity following mitoxantrone use or a cumulative lifetime dose of more than 60 mg/m2.

- 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 5 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 previous history of 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 stringent than the above

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05232825
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hoffmann-La Roche
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Trials
Principal Investigator Affiliation	Hoffmann-La Roche
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Brazil, Canada, Czechia, France, Italy, New Zealand, Poland, Spain, Turkey, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis

Arms & Interventions

Arms

Active Comparator: Ocrelizumab: Intravenous (IV) formulation

Participants will receive the first dose of ocrelizumab IV as two IV infusions given 14 days apart. The subsequent doses of study drug will be administered as SC injections. A minimum of 22 weeks should be kept between SC doses. Participants will undergo 48 weeks of study treatment.

Experimental: Ocrelizumab: Subcutaneous (SC) formulation

Participants will receive the first dose of ocrelizumab SC as one SC injection at a dose which is expected to result in non-inferior exposure to ocrelizumab IV. The subsequent doses of study drug will be administered as SC injections. A minimum of 22 weeks should be kept between the first and second SC doses, and between subsequent SC doses. Participants will undergo 48 weeks of study treatment.

Interventions

Drug: - Ocrelizumab IV

IV Injection

Drug: - Ocrelizumab SC

SC Injection

Drug: - Methylprednisolone IV

Participants will receive mandatory (corticosteroids and antihistamine) and optional (analgesic) prophylactic treatment before the start of each ocrelizumab infusion

Drug: - Diphenhydramine IV

Participants will receive mandatory (corticosteroids and antihistamine) and optional (analgesic) prophylactic treatment before the start of each ocrelizumab infusion

Drug: - Dexamethasone given orally

Participants will receive mandatory (corticosteroids and antihistamine) and optional (analgesic) prophylactic treatment before the start of each ocrelizumab injection

Drug: - Desloratadine given orally

Participants will receive mandatory (corticosteroids and antihistamine) and optional (analgesic) prophylactic treatment before the start of each ocrelizumab injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of South Florida, Tampa, Florida

Status

Active, not recruiting

Address

University of South Florida

Tampa, Florida, 33612

Site Contact

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