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Multiple SclerosisPhase 4LEGATONCT05208840

A Study To Determine The Effect Of Ocrelizumab On Leptomeningeal Inflammation In Multiple Sclerosis

A Phase 4 study testing Ocrelizumab in people with Multiple Sclerosis, run by Hoffmann-La Roche at 2 sites in Russia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will evaluate the evolution of leptomeningeal lesions via leptomeningeal contrast enhancement (LMCE) presence/disappearance after treatment administration in patients with active progressive multiple sclerosis (MS). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Ocrelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesRussia
Study dates
15 Sep 2023to 31 Jan 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients of both genders with active progressive multiple sclerosis, defined with Lublin 2013 classification: primary progressive multiple sclerosis with subsequent relapses or MRI activity (McDonald 2017 criteria), secondary progressive multiple sclerosis with relapses or MRI activity during 2 years prior to initiation of ocrelizumab.
  • It is indicated to treat patients with ocrelizumab according to local regulations.
  • EDSS ≤ 6.0.
  • Readiness for blood sampling from peripheral vein puncture.
  • Neurological stability (no clinically significant worsening according to neurological examination) for ≥30 days prior to both screening and baseline

Who cannot join

  • Inability to undergo MRI due to devices or metallic foreign bodies considered unsafe in the MRI magnet (contraindications for MRI include but are not restricted to claustrophobia, weight ≥ 140 kg, pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc.).
  • Known presence of other neurological disorders which may mimic MS including but not limited to: neuromeylitis optica, Lyme disease, untreated vitamin B12 deficiency, neurosarcoidosis and cerebrovascular disorders.
  • Known allergies to contrast agent.
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 6 months after the final dose of ocrelizumab.
  • Women of childbearing potential must have a negative serum pregnancy test result at screening.
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
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  • History or currently active primary or secondary immunodeficiency.
  • Moderately to severe kidney function decreased or severe kidney failure (Glomerular filtration rate <45 mL/min/1.73 m2 as calculated through use of the Chronic Kidney Disease Epidemiology Collaboration equation).
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
  • Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study.
  • Congestive heart failure (NYHA III or IV functional severity).
  • Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds.
  • Infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to the Baseline visit or oral antibiotics within 2 weeks prior to the Baseline visit.
  • History or known presence of recurrent or chronic infection (e.g., hepatitis B or C, HIV, syphilis, tuberculosis).
  • History of progressive multifocal leukoencephalopathy (PML).
  • History of malignancy, including solid tumors and hematological malignancies, except basal cell carcinoma, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix of the uterus that have been previously completely excised with documented, clear margins.
  • History of illicit drug or alcohol abuse within 24 weeks prior to screening, in the investigator's judgment.
  • History or laboratory evidence of coagulation disorders.
  • Receipt of a live vaccine within 6 weeks prior to baseline.
  • Treatment with any investigational agent within screening period or five half-lives of the investigational drug (whichever is longer).
  • Contraindications to or intolerance of oral or intravenous corticosteroids, including methylprednisolone administered intravenously, according to the country label, including: psychosis not yet controlled by a treatment and hypersensitivity to any of the constituents.
  • Previous therapy with B-cell depleting agents (i.e. rituximab, ocrelizumab, atacicept, belimumab or ofatumumab).
  • Systemic corticosteroid therapy within 4 weeks prior to screening.
  • Any previous treatment with alemtuzumab, anti-CD4 antibodies, cladribine, mitoxantrone, daclizumab, dimethyl fumarate, teriflunomide, laquinimod, total body irradiation or bone marrow transplantation.
  • Treatment with cyclophosphamide, azathioprine, mycophenolate mofetil (MMF), cyclosporine, methotrexate or natalizumab within 24 months prior to screening.
  • Treatment with fingolimod or other S1P receptor modulator within 24 weeks prior to screening.
  • Treatment with intravenous immunoglobulin within 12 weeks prior to baseline.
  • Positive screening tests for hepatitis B (hepatitis B surface antigen [HBsAg] positive, or positive hepatitis B core antibody [total HBcAb] confirmed by a positive viral deoxyribonucleic acid [DNA] polymerase chain reaction [PCR]) or hepatitis C (HepCAb).
  • Positive syphilis (RPR) test
  • Positive HIV infection serological test

Trial locations and contacts

2 sites in 1 country.

Russia2 sites

  • City Clinical Hospital #24; Multipal Sclerosis department

    Moskva, Moscow Oblast, 127015

  • National Center of Socially Significant Diseases

    Saint Petersburg, Sankt-Peterburg, 197110

Other trials in Russia

About this study

Official title: Open-Label Multicenter Study To Determine The Effect Of Ocrelizumab On Leptomeningeal Inflammation In Multiple Sclerosis

This study will evaluate the evolution of leptomeningeal lesions via leptomeningeal contrast enhancement (LMCE) presence/disappearance after treatment administration in patients with active progressive multiple sclerosis (MS). In addition, this study will investigate if the presence of leptomeningeal inflammation is associated with alterations of B cell repertoire and whether therapy with ocrelizumab will lead to change of B cell repertoire in LMCE-positive patients.

Being tested
Ocrelizumab
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OcrelizumabDrug

    Also called RO4964913

    Ocrelizumab will be given as slow intravenous infusion. Each treatment cycle has a duration of 6 months (5 cycles are planned in the study). The first cycle will consist of 2 infusions of 300 mg ocrelizumab (second infusion will be performed 14 days after first infusion). Cycles 2 through 5 will consist of one infusion of 600 mg ocrelizumab administered on Day 1 of each cycle.

Study groups in NCT05208840
Study groupRoleWhat they receive
LMCE-positiveExperimentalLMCE-positive participants enrolled in the study will receive therapy with ocrelizumab for 2 years.
Receives: Drug: Ocrelizumab
LMCE-negativeExperimentalLMCE-negative participants enrolled in the study will receive therapy with ocrelizumab for 2 years.
Receives: Drug: Ocrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of LMCE foci at the Month 24 visit compared to the number of LMCE foci at the Baseline visit in the LMCE-positive group

    Measured: Baseline, Month 24

Secondary outcomes (8)

  1. The change from the Baseline visit in LMCE foci at the Month 12 visit in the LMCE- positive group.

    Measured: Baseline, Month 12

  2. The change from the Baseline visit in LMCE foci at the Month 12 visit in the LMCE-negative group

    Measured: Baseline, Month 12

  3. The change from the Baseline visit in LMCE foci at the Month 24 visit in the LMCE-negative group

    Measured: Baseline, Month 24

  4. Time until 3-months composite confirmed disability progression in the LMCE-positive group and the LMCE-negative group

    Measured: Baseline to 3 months

  5. Time until 3-months confirmed disability progression in the LMCE-positive group and the LMCE-negative group

    Measured: Baseline to 3 months

  6. Time until 3-months confirmed 20% worsening in arm function (9-HPT) in the LMCE-positive group and the LMCE-negative group

    Measured: Baseline to 3 months

  7. Time until 3-months confirmed 20% worsening of gait function (T25FWT) in the LMCE-positive group and the LMCE-negative group

    Measured: Baseline to 3 months

  8. Percentage of Participants with Adverse Events

    Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0.

    Measured: Baseline up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2022
  2. Study start15 Sep 2023 (estimated)
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion31 Jan 2026 (estimated)

Why it stopped: Due to deterioration of the geopolitical situation and escalation of conflict between Russia and Ukraine ML42302 study was put on hold.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05208840
Sponsor's protocol ID
ML42302
Acronym
LEGATO
Status last verified
Jan 2024
First submitted
12 Jan 2022
Last updated
23 Jan 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ocrelizumab in people with Multiple Sclerosis, run by Hoffmann-La Roche at 2 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of LMCE foci at the Month 24 visit compared to the number of LMCE foci at the Baseline visit in the LMCE-positive group (time frame: Baseline, Month 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05208840.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.

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