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A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy (OSSIA)

4. september 2026 oppdatert av: Genentech, Inc.

A Prospective, Multicenter, Single-arm Study of Ocrelizumab Administered Subcutaneously in Patients With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy

The purpose of this study is to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) after switching from another anti-cluster of differentiation 20 (aCD20) therapy approved for RMS (ofatumumab SC, ublituximab-xiiy intravenous [IV], ocrelizumab IV) or PPMS (ocrelizumab IV).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Georgia
      • Atlanta, Georgia, Forente stater, 30327
        • Rekruttering
        • Atlanta Neuroscience Institute
    • Tennessee
      • Cordova, Tennessee, Forente stater, 38108
        • Rekruttering
        • Neurology Clinic PC
  • Puerto Rico
      • Guaynabo, Puerto Rico, 00968
        • Rekruttering
        • Caribbean Center for Clinical Research

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria
  • Documented Expanded Disability Status Scale (EDSS) score of 0-6.5, inclusive, at screening (or within 6 months of screening)
  • Participants discontinuing aCD20 therapy for reasons including, but not limited to, physician/participant preference, access to commercial drug (e.g., insurance coverage issues), or other logistical reasons (such as geographical relocation, travel, etc.) are eligible for this study
  • Prior treatment with ofatumumab SC, ublituximab-xiiy IV, or ocrelizumab IV aCD20 therapy

Exclusion Criteria:

  • Participants who have demonstrated suboptimal response to aCD20 therapy
  • Discontinuing aCD20 therapy because of any of the following treatment emergent adverse events (TEAEs): 1) Grade ≥3 severe infusion-related reaction (IRRs) or injection reactions (IRs); 2) Recurrent Grade ≥3 infections, or the need for ≥2 courses of antibiotics in the 12 months prior to screening, if the investigator believes infection is related to therapy
  • Participants with contraindication to Gd+ and participants who for any reason cannot tolerate MRI procedure
  • Known presence of active, recurrent, or chronic infection (e.g., human immunodeficiency virus [HIV], syphilis, human papillomavirus [HPV], tuberculosis [TB])
  • History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
  • Known presence of neurologic disorders that may interfere with the diagnosis of RMS or PPMS
  • Any concomitant disease that may require treatment with systemic corticosteroids (e.g., mineralocorticoids and glucocorticoids) or immunosuppressants during the study
  • Known allergy or hypersensitivity to ocrelizumab, rHuPH20, or excipients of the OCR SC formulation
  • Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
  • Treatment with any live-attenuated vaccine within 6 weeks prior to baseline
  • Treatment with any experimental procedures for RMS or PPMS (e.g., treatment for chronic cerebrospinal venous insufficiency)
  • Previous treatment with cladribine, atacicept, alemtuzumab or mitoxantrone
  • Positive hepatitis B virus (HBV) and hepatitis C virus (HCV) antibody test at screening

Other protocol defined inclusion and exclusion criteria may apply.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: OCR SC
Participants will receive OCR SC, 920 milligrams (mg) at Day 1 and at Week 24.
Legemiddel: OCR SC
Participants will receive OCR SC as per the schedule specified in the arm and the United States Prescribing Information (USPI).
Andre navn:
  • RO4964913
  • Ocrevus Zunovo® USPI;

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Percentage of Participants With no Change or Reduction From Baseline in Number of T1 Gadolinium-enhanced (Gd+) Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) at Week 24
Tidsramme: Baseline, Week 24
Baseline, Week 24

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Antall deltakere med bivirkninger (AES)
Tidsramme: Opp til uke 48
Opp til uke 48
Percentage of Participants With no New or Enlarging T2 Lesions as Detected by Brain MRI at Week 24
Tidsramme: At Week 24
At Week 24
Percentage of Participants With no Change or Reduction From Baseline in Number of T1 Gd+ Lesions as Detected by Brain MRI at Week 48
Tidsramme: Baseline, Week 48
Baseline, Week 48
Percentage of Participants With no New or Enlarging T2 Lesions as Detected by Brain MRI at Week 48
Tidsramme: At Week 48
At Week 48
Change From Baseline in Cluster of Differentiation 19 (CD19+) B-cell Counts at Week 24 and Week 48
Tidsramme: Baseline, Weeks 24 and 48
Baseline, Weeks 24 and 48
Treatment Satisfaction Score With Prior aCD20 Therapy, as Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM-II)
Tidsramme: At Day 1 (Baseline)
TSQM-II is an 11-item questionnaire with a 2- to 3-week recall period or since last use of medication. The questionnaire includes 4 domains: an effectiveness scale, a side effects scale, a convenience scale, and a global satisfaction scale. Each item is rated using Likert-type scales of 5 or 7 points and dichotomous (Yes/No) responses with higher scores corresponding to higher satisfaction in that domain.
At Day 1 (Baseline)
Treatment Administration Satisfaction Score After Dose of OCR SC at Day 1 and Week 24, as Assessed Using Treatment Administration Satisfaction Questionnaire - Subcutaneous Injection (TASQ SC)
Tidsramme: At Day 1 (Baseline) and Week 24
TASQ SC is a 13-item questionnaire to evaluate participants' experience on their most recent OCR SC administration. The questionnaire consists of items related to SC injections, each rated on a 3- or 5-point Likert scale with higher scores corresponding to higher satisfaction and/or a more positive experience.
At Day 1 (Baseline) and Week 24
Treatment Satisfaction Score With OCR SC at Week 24 and Week 48, as Assessed Using TSQM-II
Tidsramme: At Weeks 24 and 48
TSQM-II is an 11-item questionnaire with a 2- to 3-week recall period or since last use of medication. The questionnaire includes 4 domains: an effectiveness scale, a side effects scale, a convenience scale, and a global satisfaction scale. Each item is rated using Likert-type scales of 5 or 7 points and dichotomous (Yes/No) with higher scores corresponding to higher satisfaction in that domain.
At Weeks 24 and 48
Change From Baseline in Multiple Sclerosis Impact Scale (MSIS-29) Scores at Week 24 and Week 48
Tidsramme: Baseline, Weeks 24 and 48
MSIS-29 is a 29-item questionnaire to examine the impact of MS on physical and psychological functioning from a participant's perspective. Participants are asked to rate how much their functioning and well-being have been impacted over the past 14 days on a 4-point scale, from 1 = "Not at all" to 4 = "Extremely". The physical score is the sum of items 1-20, which is then transformed to a 0-100 scale. The psychological score is the sum of items 21-29, transformed to a 0-100 scale. Higher scores indicate a greater impact of MS.
Baseline, Weeks 24 and 48
Number of Participants who Switched From Approved aCD20 Therapy to OCR SC, Categorized by Reasons for Switching
Tidsramme: At Baseline
At Baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Genentech, Inc.

Etterforskere

  • Studieleder: Clinical Trials, Hoffmann-La Roche

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. september 2026

Primær fullføring (Antatt)

28. februar 2029

Studiet fullført (Antatt)

28. februar 2029

Datoer for studieregistrering

Først innsendt

20. mai 2026

Først innsendt som oppfylte QC-kriteriene

20. mai 2026

Først lagt ut (Faktiske)

27. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ML46740

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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