A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis, Primary Progressive

In brief

This study will evaluate the efficacy and safety of ocrelizumab (Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study will consist of the following phases: screening, double-blind treatment, an optional post-double-progression ocrelizumab (PDP OCR) treatment, follow-up 1 (FU1), an optional open-label extension (OLE), and follow-up 2 (FU2).

Key facts

Study ID

NCT04035005

Run by

Hoffmann-La Roche

People needed

1013

Starts

2019-08-12

Expected to finish

2028-01-19

Last updated by the study team

2026-02-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• EDSS score at screening and baseline >= 3.0 to 8.0, inclusive
• Disease duration from the onset of MS symptoms relative to randomization date:
• Less than 20 years in participants with an EDSS score at screening 7.0 - 8.0 Less than 15 years in participants with an EDSS at screening 5.5 - 6.5 Less than 10 years in participants with an EDSS at screening <= 5.0
• Documented history or presence at screening of at least one of the following laboratory findings in a cerebrospinal fluid specimen: Elevated immunoglobulin G (IgG) index or one or more IgG oligoclonal bands detected by isoelectric focusing
• Screening and baseline 9-HPT completed in > 25 seconds (average of the two hands)
• Neurological stability for ≥ 30 days prior to baseline
• Ability to complete the 9-HPT within 240 seconds with each hand at screening and baseline
• Neurological stability for >/= 30 days prior to baseline
• Participants previously treated with immunosuppressants, immunomodulators, or other immunomodulatory therapies must undergo an appropriate washout period according to the local label of the immunosuppressant/immunomodulatory drug used
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods during the treatment period and for 6 or 12 months after the final dose of ocrelizumab. Adherence to local requirements, if more stringent, is required.
• For female participants without reproductive potential: Women may be enrolled if surgically sterile (i.e hysterectomy, complete bilateral oophorectomy) or post-menopausal unless the participant is receiving a hormonal therapy for her menopause or if surgically sterile

You may not qualify if…

• History of relapsing-remitting or secondary progressive MS at screening
• Confirmed serious opportunistic infection including: active bacterial, viral, fungal, mycobacterial infection or other infection, including tuberculosis or atypical mycobacterial disease
• Participants who have or have had confirmed or a high degree of suspicion of progressive multifocal leukoencephalopathy (PML)
• Known active malignancy or are being actively monitored for recurrence of malignancy
• Immunocompromised state
• Receipt of a live-attenuated vaccine within 6 weeks prior to randomization
• Inability to complete an MRI or contraindication to Gd administration.
• Participants requiring symptomatic treatment of MS and/or physiotherapy who are not on a stable regimen. Participants must not initiate symptomatic treatment of MS or physiotherapy within 4 weeks of randomization.
• Contraindications to mandatory premedications for infusion-related reactions, including:
• uncontrolled psychosis for corticosteroids and closed-angle glaucoma for antihistamines
• Known presence of other neurologic disorders
• Pregnant or breastfeeding, or intending to become pregnant during the study and for 6 or 12 months after last infusion of the study drug
• Lack of peripheral venous access
• Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participant from participating in the study
• Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
• History of alcohol or other drug abuse
• History of primary or secondary immunodeficiency
• Treatment with any investigational agent within 24 weeks prior to screening (Visit 1) or 5 half-lives of the investigational drug (whichever is longer), or treatment with any experimental procedure for MS
• Previous treatment with B-cell targeting therapies
• 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 serum human chorionic gonadotropin (hCG) measured at screening or positive urine β-hCG at baseline
• Positive screening tests for hepatitis B

Where it is running

• MS and Neuromuscular Center of Excellence — Clearwater, Florida, United States
• Neurological Services of Orlando — Orlando, Florida, United States
• Vero Neurology — Vero Beach, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company — Columbus, Ohio, United States
• Columbus Neuroscience — Westerville, Ohio, United States
• Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States
• Brain and Mind Research Institute — Camperdown, New South Wales, Australia
• Austin Hospital — Heidelberg, Victoria, Australia
• Royal Melbourne Hospital — Parkville, Victoria, Australia
• UZ Antwerpen — Edegem, Antwerpen, Belgium
• Cliniques Universitaires St-Luc — Brussels, Belgium
• MS & Neurologisch Revalidatie Centrum — Overpelt, Belgium
• Military Medical Academy HBAT — Pleven, Bulgaria
• Multiprofile Hospital For Active Treatment Avis Medica — Pleven, Bulgaria
• Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD — Sofia, Bulgaria
• University of Alberta — Edmonton, Alberta, Canada
• Dalhousie Multiple Sclerosis Research Unit — Halifax, Nova Scotia, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• Recherche Sepmus Inc. — Greenfield Park, Quebec, Canada
• Instituto Neurologico de Colombia INDEC — Medellín, Antioquia, Colombia
• Clinica Colsanitas S.A. sede Clinica Universitaria Colombia — Bogotá, Colombia
• General Hospital Varazdin — Varaždin, Croatia
• Clinical Hospital Sestre Milosrdnice — Zagreb, Croatia
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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